Systematically Testing the Evidence on Marijuana

Hippocampal Sclerosis (HS) leads to anterograde amnesia mimicking early Alzheimer's disease (AD) (so called HSA-nonAD). Recent studies showed that (a) the deficit of episodic memory as well as the level of hippocampal atrophy in bvFTD may be of similar severity to that observed in AD, even at initial presentation, leading to misdiagnosis in 22% of cases with post mortem diagnosis; (b) amnesia with HS due to microvascular lesion and microinfarcts can also cause impairment of episodic memory mimicking AD, without subcortical cognitive profile. Because these diseases involve distinct pathophysiological processes, they require different specific care and treatment. In consequence, it is very important to improve our knowledge about HS in order to identify its mechanism and improve the diagnosis.

First Posted: October 15, 2015

Condition(s): Patients With Cognitive Disturbances

Intervention(s): Neurological examinations, Neuropsychological examinations, Clinical examinations, MRI 3T, MRI 7T

Status: Recruiting

Enrollment (expected or actual): 140

Allocation: Non-Randomized

Sponsor: Centre Hospitalier St Anne

Principal Investigator:

Completion Date (primary or actual): January 2020

CT.gov Identifier: NCT02576821

The study is designed to study the efficacy of IV OsrHSA or positive control HSA (10 g and 20 g IV everyday) for 14 days. After a screening period of up to 14 days, the eligible subjects will be randomized in a 4:1 ratio to OsrHSA and positive control HSA, respectively, in each cohort. Each enrolled subject will receive multiple assigned doses of OsrHSA. The Investigator and subjects will be blind to treatment assignment (OsrHSA or positive control HSA) in each cohort. During the study, subjects will be evaluated for efficacy, safety, tolerability, and immunogenicity. In each cohort, subjects will be stratified by baseline serum albumin level. If serum albumin reaches 35 g/L or more, the study drug or control drug administration may be terminated early. Subjects will have 3 follow-up visits in 2 weeks.

First Posted: April 8, 2021

Condition(s): Cirrhotic Ascites

Intervention(s): OrsHSA, HSA

Status: Recruiting

Enrollment (expected or actual): 220

Allocation: Randomized

Sponsor: Healthgen Biotechnology Corp.

Principal Investigator:

Completion Date (primary or actual): June 30, 2022

CT.gov Identifier: NCT04835480

A first-in-human study using TT-816 as a single agent and in combination with a PD-1 inhibitor in advanced cancers.

First Posted: September 1, 2022

Condition(s): Advanced Cancer, Advanced Solid Tumor, Cancer, Oncology

Intervention(s): TT-816, A PD-1 inhibitor

Status: Terminated

Enrollment (expected or actual): 9

Allocation: Non-Randomized

Sponsor: Teon Therapeutics, Inc.

Principal Investigator:

Completion Date (primary or actual): September 7, 2023

CT.gov Identifier: NCT05525455

This will be a randomised, double-blind, placebo-controlled, parallel-arm trial, designed to study the efficacy and safety of co-micronised palmithoylethanolamide/polydatin in pediatric patients (> 10 years) with Irritable bowel syndrome (IBS)

First Posted: May 22, 2023

Condition(s): Irritable Bowel Syndrome

Intervention(s): palmithoylethanolamide/polydatin, placebo

Status: Recruiting

Enrollment (expected or actual): 70

Allocation: Randomized

Sponsor: University of Roma La Sapienza

Principal Investigator: Prof. Giovanni Di Nardo, Professor

Completion Date (primary or actual): October 19, 2023

CT.gov Identifier: NCT05867693

This research is an experimental study with a randomized pre-test-post-test control group to evaluate the effect of the cognitive behavioral approach-based stress coping skills training program carried out by tele-nursing on the palliative care nurses' perception of stress, resilience and compassion fatigue. The main questions it aims to answer are: Question 1. Will the cognitive behavioral approach-based stress coping skills training program to be carried out through tele-nursing have an effect on the increase in the stress coping score of the palliative care nurses in the intervention group? Question 2. Will the cognitive behavioral approach-based stress coping skills training program to be carried out through tele-nursing have an effect on the reduction of stress perception among palliative care nurses in the intervention group? Question 3. Will the cognitive behavioral approach-based stress coping skills training program to be carried out through tele-nursing have an impact on the increase in resilience of palliative care nurses in the intervention group? Question 4. Will the cognitive behavioral approach-based stress coping skills training program to be carried out through tele-nursing have an effect on the reduction of compassion fatigue in palliative care nurses in the intervention group? The research was planned as a randomized controlled experimental design with the required ethics committee and institution permissions, a three-month announcement and initiation period, and an eight-week intervention period. Data will be collected twice at baseline and after intervention (Week 9). Personal information form, Perceived Stress Scale, Coping with Stress Scale, Connor-Davidson Resilience Scale, Quality of Life Scale for Employees will be used in the pre-test phase of data collection. Participants meeting the inclusion criteria will be assigned to the intervention and control groups by randomization. In order to support nurses in the intervention group to gain awareness of stress and anxiety and develop positive coping skills with stress, a total of 8 sessions of 40 minutes are planned, including interaction steps based on education and cognitive approach. Individuals will be given homework from the second week and they will be asked to deliver these homeworks to the researcher 2 days before the next interview, and it is planned to send reminder messages from the WastApp group created. Participants who do not deliver the assignments given in this study to the researcher on time will be excluded from the research even if they participate in online training. No intervention will be applied to individuals assigned to the control group. Participants will be informed about the Mobile Mental Health Support System created by the Turkish Ministry of Health and will be directed to this application. It is planned to apply Perceived Stress Scale, Coping with Stress Scale, Connor-Davidson Resilience Scale, Quality of Life Scale for Employees at the 9th week for the application of post-tests.

First Posted: April 26, 2023

Condition(s): Stress Perception, Psychological Resilience, Compassion Fatigue

Intervention(s): Cognitive Behavioral Therapy, T.R. Mobile Mental Health Support System produced by the Ministry of Health

Status: Recruiting

Enrollment (expected or actual): 42

Allocation: Randomized

Sponsor: Eskisehir Osmangazi University

Principal Investigator: Ozge AYDOGAN ASIR, Principal İnvestigator

Completion Date (primary or actual): January 15, 2023

CT.gov Identifier: NCT05830448

Accurate patient information disclosure is critical to provide optimal treatment. Methods that can detect and then increase the truthfulness of information are relatively unknown. To investigate the impact of communication about privacy, benefits, and risk on patient truthfulness, the investigators test two new methods to detect patient truthfulness and demonstrate the effects of privacy notices (e.g. HIPPA statements). Participants include a national online sample randomly assigned to one of six treatment statements that might be typically given before health information was requested. The assigned treatments include one or mix of the following: privacy notice, statement of the benefits of accurate disclosure, and statement of the risks of inaccurate disclosure and control of no statement before being asked typical health questions. The investigators propose that based on elaboration likelihood model, statements reminding participants of their privacy will increase lying. The investigators hypothesis the use of a new biometric mouse movement lie detection method and answer adjustment can measure patient lies. The investigators hypothesis that reminders of the risk of not telling the truth will reduce lying due to risk aversion. Lastly the investigators hypothesis that statements of benefits of answering truthfully will increase truthfulness.

First Posted: March 17, 2021

Condition(s): Patient Lying, Privacy Statements, Risk Statements, Benefit Statements, Patient Lie Detection

Intervention(s): Benefit statement, Risk Statement, Privacy Statement, Benefit + Privacy, Risk + Privacy

Status: Completed

Enrollment (expected or actual): 619

Allocation: Randomized

Sponsor: University of Utah

Principal Investigator: Tamara Masters, PhD, Assistant Professor

Completion Date (primary or actual): April 19, 2020

CT.gov Identifier: NCT04803448

Endoscopic bile duct stone (BDS) removal is a well-established treatment; however, the preference for basket or balloon catheters for extraction is operator-dependent It is reported that complete endoscopic treatment with a single catheter is more likely when choosing a balloon catheter over a basket catheter for extraction of BDSs≤10mm. However, a study comparing the two catheter types in patients with periampullary diverticulum has not been performed, and there is no strong basis on which to recommend the balloon catheter as a first-line stone removal device. The investigators therefore conducted a multicenter prospective randomized trial to compare catheter performance in patients with periampullary diverticulum.

First Posted: September 21, 2016

Condition(s): Biliary Calculi

Intervention(s): Balloon catheter, Basket catheter

Status: Completed

Enrollment (expected or actual): 80

Allocation: Randomized

Sponsor: Anhui Provincial Hospital

Principal Investigator:

Completion Date (primary or actual): November 2016

CT.gov Identifier: NCT02909595

The goal of this clinical trial is to investigate efficacy and safety of an herbal medicinal product of (NW Low-Glu®) in patients with Type 2 Diabetes Mellitus (T2DM). The main question[s] it aims to answer are: • What will be the mean change in HbA1c levels in the experimental arm (NW Low-Glu®) compared to the active-control arm (metformin) after 6 months of treatment? Participants will randomized in a 1:1 allocation ratio, into one of the two treatment groups, to receive either Metformin or NW Low-Glu®. Researchers will compare the mean change in HbA1C, fasting blood glucose, and weight between the experimental arm and the active-control arm.

First Posted: November 20, 2023

Condition(s): Diabetes Mellitus, Type 2

Intervention(s): NW Low-Glu®, Metformin

Status: Not yet recruiting

Enrollment (expected or actual): 400

Allocation: Randomized

Sponsor: Natural Wellness Egypt

Principal Investigator:

Completion Date (primary or actual): September 2025

CT.gov Identifier: NCT06140485

Previous studies have demonstrated that coached EMS practice at the beginning of ERCP training could improve the trainees' skill. However, it is not known whether continuously coached practice using EMS can provide additional benefit.

First Posted: December 30, 2013

Condition(s): Selective Cannulation Rate of Trainees Receiving ERCP Training

Intervention(s): Hands-on EMS training, Standard training

Status: Suspended

Enrollment (expected or actual): 400

Allocation: Randomized

Sponsor: Air Force Military Medical University, China

Principal Investigator: Yanglin Pan, Associated professor

Completion Date (primary or actual): December 2016

CT.gov Identifier: NCT02022605

The purpose of this study is to determine the long term safety and clinical utility of IPX066 in subjects with Parkinson's Disease.

First Posted: March 31, 2010

Condition(s): Parkinson's Disease

Intervention(s): IPX066 95 mg, IPX066 145 mg, IPX066 195 mg, IPX066 245 mg

Status: Completed

Enrollment (expected or actual): 617

Allocation: N/A

Sponsor: Impax Laboratories, LLC

Principal Investigator:

Completion Date (primary or actual): October 2011

CT.gov Identifier: NCT01096186

This study examines the efficacy of three doses of IPX066 as compared to placebo in Parkinson's disease.

First Posted: April 14, 2009

Condition(s): Parkinson's Disease

Intervention(s): Placebo, IPX066 95 mg LD, IPX066 145 mg LD, IPX066 195 mg LD, IPX066 245 mg LD

Status: Completed

Enrollment (expected or actual): 381

Allocation: Randomized

Sponsor: Impax Laboratories, LLC

Principal Investigator:

Completion Date (primary or actual): October 2010

CT.gov Identifier: NCT00880620

This is a first in human, randomized, double-blind, placebo-controlled SAD (with food effect) followed by a MAD study of Trichomylin® conducted in healthy adult participants.

First Posted: April 30, 2021

Condition(s): Healthy, Osteoarthritis

Intervention(s): Trichomylin for SAD, Placebo for SAD, Trichomylin for MAD, Placebo for MAD

Status: Completed

Enrollment (expected or actual): 41

Allocation: Randomized

Sponsor: ZYUS Life Sciences Inc.

Principal Investigator:

Completion Date (primary or actual): February 18, 2022

CT.gov Identifier: NCT04867057

This study aims to demonstrate the efficacy and safety of BIA 9-1067, compared with entacapone or placebo, when administered with the existing treatment of L-DOPA plus a Dopa Decarboxylase Inhibitor (DDCI), in patients with Parkinson's Disease (PD) and end-of-dose motor fluctuations.

First Posted: April 2, 2012

Condition(s): Parkinson's Disease

Intervention(s): BIA 9-1067, Entacapone, Placebo, Levodopa, Carbidopa, Benserazide

Status: Completed

Enrollment (expected or actual): 600

Allocation: Randomized

Sponsor: Bial - Portela C S.A.

Principal Investigator:

Completion Date (primary or actual): November 2013

CT.gov Identifier: NCT01568073

A significant number of patients with Parkinson's disease (PD) face motor fluctuations even after repeated titration of the dosing of Levodopa. Dealing with OFF state really becomes problematic for them. Aggravation of bradykinesia, rigidity, tremor and gait difficulty are the common problems in OFF state. Studies are going on drugs like Apomorphine as rescue therapy in OFF state. Recently there are studies with Noninvasive brain stimulation, as an evolving therapeutic option in different neurodegenerative diseases. In this study, the investigators are to evaluate the efficacy of transcranial pulsed current stimulation (tPCS) in the OFF state in PD patients. The investigators will give stimulation via tPCS (active/sham). EEG, Kinematic measurement of upper limb movement via KinArm, Unified Parkinson's Disease Rating Scale (UPDRS) scoring will be done and gait will be assessed via Gait Carpet - pre and post-stimulation. The investigators will evaluate the effectiveness of tPCS as a single modality or in combination with Levodopa in managing OFF state of PD.

First Posted: August 13, 2019

Condition(s): Parkinson Disease

Intervention(s): Active tPCS, Sham tPCS, Levodopa tablet

Status: Not yet recruiting

Enrollment (expected or actual): 15

Allocation: Randomized

Sponsor: Western University, Canada

Principal Investigator: Mandar Jog, Professor

Completion Date (primary or actual): September 2021

CT.gov Identifier: NCT04054960

The primary objective of this study is to enroll an observational cohort of approximately 60 patients with PSP over the course of 24 months using a multicenter study design and to follow each of them for 12 months. The secondary objective of this study is to develop a robust solution for multi-modal remote monitoring of motor symptoms and function in PSP that can be applied to other Frontotemporal lobar degeneration (FTLD) syndromes.

First Posted: July 21, 2023

Condition(s): PSP, CBD, Progressive Supranuclear Palsy, FTD, Corticobasal Degeneration, Frontotemporal Dementia, Frontotemporal Lobar Degeneration

Intervention(s): PAMSys, LEGSys

Status: Recruiting

Enrollment (expected or actual): 60

Allocation:

Sponsor: Massachusetts General Hospital

Principal Investigator: Anne-Marie Alexandra Wills, MD, Assistant Professor of Neurology

Completion Date (primary or actual): July 30, 2025

CT.gov Identifier: NCT05956834

In Denmark, more than 7500 cholecystectomies are performed every year. Common bile duct gallstones (CBDS) are found in 3.4% to 18% of patients undergoing cholecystectomy. A two-step approach including endoscopic retrograde cholangiography (ERC) with stone extraction and papillotomy with subsequent laparoscopic cholecystectomy has become gold standard for treatment of CBDS in Denmark. However, ERC is associated with a high risk of complications and more than 50% of patients require multiple ERCs. Recent meta analyses find that a one-step approach might be superior in terms of safety, CBDS clearance rate, hospital stay, operative time, hospital cost and stone recurrence, but much more data is needed. The preGallstep trial is an investigator-initiated multicentre randomised clinical pilot trial with blinded outcome assessment investigating a novel one-step laparoscopic cholecystectomy with common bile duct exploration and stone extraction versus conventional two-step endoscopic retrograde cholangiography with stone extraction plus a subsequent laparoscopic cholecystectomy for patients with CBDS. After enrolment, the participant will be randomised to one of the two treatment approaches. Adult patients with imaging confirmed CBDS are eligible for inclusion. Potential postoperative complications will be assessed within 90 days following the procedure. The primary outcome is the proportion of serious adverse events (corresponding to a Clavien-Dindo score II or above) requiring re-intervention within 90 days of the initial procedure. This outcome will be used for a future sample size calculation. The sample size estimate, the inclusion rate and the estimated length of subsequent trial will be used to determine the feasibility of a large pragmatic and confirmatory trial. We hypothesize that the one-step approach will significantly reduce the risk of complications and number of treatments needed thereby making a difference to hundreds of people in Denmark each year.

First Posted: March 16, 2021

Condition(s): Pancreatitis, Cholangitis, Cholecystitis; Gallstone, Jaundice, Obstructive

Intervention(s): LCBDE + LC, ERC + LC

Status: Recruiting

Enrollment (expected or actual): 150

Allocation: Randomized

Sponsor: Lars Tue Sorensen

Principal Investigator: Lars Tue Sorensen, Head of Surgical Department

Completion Date (primary or actual): December 31, 2023

CT.gov Identifier: NCT04801238

The investigators aim to learn more about symptoms suggestive of a neurodegenerative process.

First Posted: December 22, 2020

Condition(s): PSP, CBD, PCA, LPA, Semantic Dementia, Semantic Aphasia, Behavioral Variant of Frontotemporal Dementia, FTD, PPA, Apraxia of Speech, MSA - Multiple System Atrophy, Parkinson Disease

Intervention(s): C-11 PiB, AV1451 Tau, C-11 ER176

Status: Enrolling by invitation

Enrollment (expected or actual): 500

Allocation:

Sponsor: Mayo Clinic

Principal Investigator: Keith A. Josephs, Professor of Neurology

Completion Date (primary or actual): November 2050

CT.gov Identifier: NCT04680130

The plant Melissa officinalis L. is commonly used to treat disorders related to anxiety and sleep quality. It contains several phytochemicals that give it antioxidant, anti-inflammatory, antispasmodic, antimicrobial, and neuroprotective properties. A study on subjects with mild to moderate anxiety and sleep disorders showed that an extract of Melissa officinalis reduced anxiety manifestations by 18%, improved symptoms associated with anxiety by 15%, and reduced insomnia by 42%. However, that study did not have a control group, so a randomized trial with a control group is needed. The objective of the study will be to evaluate the beneficial effects of a phytosome-formulated Melissa officinalis extract on sleep duration and different stages of sleep, which will be monitored using a wrist device. She will be provided with a wrist device that will be used for sleep monitoring. The trial will last for 45 days, in which she will be asked to take the phytosome-formulated Melissa supplement for two 14-day periods (2 tablets, 30 minutes before bedtime). There will be a 7-day break in the intake period between the two periods. At the beginning, middle, and end of the trial, you will be asked to answer some questionnaires.

First Posted: July 18, 2023

Condition(s): Sleep Disorder, Anxiety, Quality of Life

Intervention(s): Melissa phytosome, Placebo

Status: Not yet recruiting

Enrollment (expected or actual): 40

Allocation: Randomized

Sponsor: University of Urbino "Carlo Bo"

Principal Investigator: Davide Sisti, PhD

Completion Date (primary or actual): March 2024

CT.gov Identifier: NCT05950932

To test the benefits of ERCP Mechanical Simulator (EMS) practice in improving ERCP cannulation success rate of novice surgical trainees.

First Posted: July 20, 2016

Condition(s): Hands-on Training

Intervention(s): ERCP Mechanical Simulator (EMS)

Status: Completed

Enrollment (expected or actual): 12

Allocation: Randomized

Sponsor: Hepatopancreatobiliary Surgery Institute of Gansu Province

Principal Investigator:

Completion Date (primary or actual): December 26, 2018

CT.gov Identifier: NCT02838498

As a first-in-class (Central Pattern Generator or CPG activator) approach, this tritherapy candidate called SPINALON has been identified and is currently under development for its capacity to temporarily induce episodes of involuntary locomotor movements. The primary objective of this Phase I/IIa study is to assess safety and tolerability of a single escalating dose of SPINALON (levodopa + carbidopa + buspirone) in chronic spinal cord-injured patients. As a secondary objective, preliminary evidence of efficacy will also be sought.

First Posted: December 2, 2011

Condition(s): Spinal Cord Injury

Intervention(s): SPINALON (buspirone + levodopa + cardidopa)

Status: Completed

Enrollment (expected or actual): 50

Allocation: Randomized

Sponsor: Nordic Life Science Pipeline Inc.

Principal Investigator:

Completion Date (primary or actual): August 2015

CT.gov Identifier: NCT01484184

The aim of the planned research is to assess the dynamics of changes in the elements of the gut-brain axis (GBA), the cytokine profile and the endocannabinoid system markers, after dietary supplementation with probiotics Lactobacillus helveticus Rosell-52 and Bifidobacterium longum Rosell-175 by professional dancers. Although in recent years there has been growing interest in the influence of the gut microbiota on the body's adaptation to stress stimuli and on overall health, there is a lack of information on the influence of probiotics on systems involved in maintaining neuropsychiatric balance, such as the endocannabinoid system. In order to determine the validity of the applied therapy with selective probiotics, the following will be assessed: intestinal bacteria and bacterial metabolites in the stool, cannabinoids and cannabinoid receptors and enzymes in the blood, indicators of mental distress in the blood, cytokines responsible for the modulation of the gut-brain axis in the blood, as well as questionnaires regarding the functioning of the digestive tract, fatigue, stress and sleep quality. The study will involve active dancers of the Polish Theater in Poznan, the Polish Dance Theater, the Private School of Dance Art in Poznan and students of the Academy of Physical Education in the field of Dance. Dancers are a group of athletes that is exposed to particular injuries and work-overload. Professional dancers spend multiple hours a week on intensive physical training. The largest percentage of injuries occurring in the group of professional dancers are chronic injuries, including: inflammation of soft tissues, muscle strains and tears. Professional dance is one of the most physically demanding forms of physical activity, and at the same time it is associated with a high burden on the nervous system problems caused by performances in front of an audience or subjective jury, frequent traveling and disturbances in the circadian rhythm.

First Posted: October 5, 2022

Condition(s): Fatigue, Stress, Job

Intervention(s): Lactobacillus helveticus Rosell-52 and Bifidobacterium longum Rosell-175 (Sanprobi Stress), Starch (placebo)

Status: Recruiting

Enrollment (expected or actual): 60

Allocation: Randomized

Sponsor: Poznan University of Physical Education

Principal Investigator: Jakub Wiącek, Principal Investigator

Completion Date (primary or actual): October 2022

CT.gov Identifier: NCT05567653

The overall median survival of nonresectable malignant hilar obstruction in most series has been less than 6 months. Most patients with malignant hilar obstruction present with advanced disease, making allative endoscopic drainage the principal therapeutic option. However, the optimal endoscopic management strategy is contentious. In malignant hilar obstruction, exclusively endoscopic placement of bilateral metal stents has been considered very difficult and complex, and it may require multiple procedures, with an increased risk of complications and mortality. To overcome this difficulty and strategize plan of management, the investigators evaluated the technical and clinical efficacy of endoscopic bilateral placement of newly designed stents, Y-configuration, followed by side-by-side insertion in failure of stent-in-stent method for the management of malignant hilar obstruction.

First Posted: June 10, 2010

Condition(s): Malignant Hilar Stricture, Bilateral Stent Insertion

Intervention(s): Bilateral stent-in-stent insertion, Bilateral side-by-side insertion

Status: Recruiting

Enrollment (expected or actual): 80

Allocation: Randomized

Sponsor: Soon Chun Hyang University

Principal Investigator: Tae Hoon Lee, MD, PhD

Completion Date (primary or actual): March 30, 2018

CT.gov Identifier: NCT01141088

The aim of this study is to increase norepinephrine levels in a population of young adults where NE levels are very low or undetectable. In order to achieve this, the optimal dose will be determined in a titration step. In the titration step, different doses of L-DOPS will be tested in order to find the optimal and safest dose suitable for each individual enrolled in the study. Because L-DOPS has never been used in the US in children or young adults, with this titration step investigators will also determine the safest dose for this population. Currently, L-DOPS is being used in our center to treat othostatic hypotension in autonomic failure. The titration step for this study starts with the dose of 100 mg and increases in an escalating manner up to a maximum of 600 mg a day (see investigational brochure attached). L-DOPS has been developed in capsules for oral used and all the previous safety data has been performed using this route. Oral route is the one that will used during study. Carbidopa is well tolerated, safe in children and it has been used in this population in the US without severe adverse effects.

First Posted: December 8, 2015

Condition(s): HSAN Type IV

Intervention(s): Droxidopa (L-DOPS), Placebo

Status: Withdrawn

Enrollment (expected or actual): 0

Allocation: Randomized

Sponsor: NYU Langone Health

Principal Investigator:

Completion Date (primary or actual): January 2019

CT.gov Identifier: NCT02624310

The purpose of this study is to determine the relative bioavailability (rBA; Period 1) and bioequivalence (BE; Period 2 and 3) of various strengths and formulations of niraparib and abiraterone acetate (AA) at steady state under modified fasted conditions in participants with metastatic castration-resistant prostate cancer (mCRPC).

First Posted: October 8, 2020

Condition(s): Prostatic Neoplasms

Intervention(s): Niraparib, Abiraterone Acetate (AA), Prednisone

Status: Active, not recruiting

Enrollment (expected or actual): 136

Allocation: Randomized

Sponsor: Janssen Research & Development, LLC

Principal Investigator:

Completion Date (primary or actual): October 15, 2021

CT.gov Identifier: NCT04577833

Dental fluorosis is a clinical manifestation of chronic exposure to high intakes of fluoride during the tooth development. The present study is planned to evaluate the efficacy of Resin Infiltration technique in improving the esthetics of non-pitted fluorosis stains on permanent anterior teeth. Resin infiltration is a novel method that has shown its efficacy in improving the esthetics of various types of white spot lesions (WSLs), particularly post orthodontics WSLs, in in-situ and in-vivo studies. The Resin Infiltration technique is also known to stop the progression of caries in non cavitated lesions in both, smooth surface and interproximal lesions. Therefore, the following trial will be conducted to assess the esthetic improvement of fluorosed permanent anterior teeth after resin infiltration and compare it with standard bleaching procedure and a combination of bleaching and Resin infiltration therapy in children with fluorosed teeth.

First Posted: November 27, 2012

Condition(s): Caries Infiltration, Fluorosis, Dental Care

Intervention(s): Office Bleaching, Resin Infiltration, Resin Infiltration twice, Bleaching + Resin Infiltration

Status: Completed

Enrollment (expected or actual): 80

Allocation: Randomized

Sponsor: DMG Dental Material Gesellschaft mbH

Principal Investigator:

Completion Date (primary or actual): December 2013

CT.gov Identifier: NCT01733888