- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04572386
Clinical Performance of Low Technique Sensitive Self Cured Universal Adhesive Vrs Light Cured Universal Adhesive in Patients With (NCCLs): 18 m RCT
September 26, 2020 updated by: Aya Gamal ashour
Clinical Performance of Low Technique Sensitive Self-cured Universal Adhesive Versus Light Cured Universal Adhesive in Patients With Non-carious Cervical Lesions (NCCLs): 18 Month Randomized Clinical Trial
This study will be conducted to evaluate the clinical performance of self-cured adhesive versus light cured universal adhesive in non-carious cervical lesions (NCCL) resin composite restorations after 18 month
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
28
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Aya Gamal, masters
- Phone Number: 01004222615
- Email: yoyo_ga@hotmail.com
Study Contact Backup
- Name: Rawda husien, Phd
- Phone Number: 01001097200
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- particepant with age rang 18-55
- particepant with non carious cervical lesion
Exclusion Criteria:
- particepant outside age rang
- particepant with periodontal problem that might affect the teeth to be treated
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Light cure universal bond
light cured 3m single bond universal
|
light -cure universal bond
|
Active Comparator: self cure universal bond
self-cure universal bond (Palfique, Tokuyama, Japan)
|
Self-cure universal bond with no light cure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of fracture restoration
Time Frame: 18 month
|
Frist visual evaluation to ensure that there is no complete loss of retention of the restoration then tactile evaluation will be done using probe tip that will be held gently at right angle to the labial surface and move from restoration to tooth and vice versa to insure no rocking /fracture /ditching in the restoration following FDI criteria ( first visually for total loss .followed
by tactile inspection using fdi prob for any fracture /rocking or loss of retention
|
18 month
|
number of restoration with retention loss
Time Frame: 18-month
|
Frist visual evaluation to ensure that there is no complete loss of retention of the restoration then tactile evaluation will be done using probe tip that will be held gently at right angle to the labial surface and move from restoration to tooth and vice versa to insure no rocking /fracture /ditching in the restoration following FDI criteria
|
18-month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of restoration with change in colour or texture
Time Frame: 18 month
|
Evaluation will be done visually following FDI criteria to ensure no change in colour or texture of the restoration
|
18 month
|
Number of restoration caused biological harm
Time Frame: 18 month
|
Evaluation will be done following FDI criteria using FDI prob to ensure no change in restoration that caused any harm to the health of biological strucure
|
18 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2020
Primary Completion (Anticipated)
May 1, 2022
Study Completion (Anticipated)
July 1, 2022
Study Registration Dates
First Submitted
September 11, 2020
First Submitted That Met QC Criteria
September 26, 2020
First Posted (Actual)
October 1, 2020
Study Record Updates
Last Update Posted (Actual)
October 1, 2020
Last Update Submitted That Met QC Criteria
September 26, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- gsda.1986.2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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