Clinical Performance of Low Technique Sensitive Self Cured Universal Adhesive Vrs Light Cured Universal Adhesive in Patients With (NCCLs): 18 m RCT

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Non Carious Cervical Lesion

Intervention / Treatment
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* Other: light cure 3m single bond universal bond
* Other: Self-cure universal bond (Palfique, Tokuyama, Japan)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Light cure universal bond<br>light cured 3m single bond universal | Other: light cure 3m single bond universal bond<br>* light -cure universal bond<br>|
| Active Comparator: self cure universal bond<br>self-cure universal bond (Palfique, Tokuyama, Japan) | Other: Self-cure universal bond (Palfique, Tokuyama, Japan)<br>* Self-cure universal bond with no light cure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of fracture restoration | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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universal bond, NCCls, 3m single bond universal, Palfique, Tokuyama, Japan, self cure, non carious cervical lesions