the Clinical Performance of a Moisture Resistant, M-TEG-P Phosphate Monomer Based Universal Adhesive (YAMAKIN TMR-Aquabond0) Compared to the Conventional Universal Adhesive (3m ESPE Single Bond Universal Adhesive)

Study Overview
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Brief Summary
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this trial is to test the clinical performance of a novel moisture resistant, M-TEG-P phosphate monomer based universal adhesive (YAMAKIN TMR-Aquabond0) compared to the conventional universal adhesive (3m ESPE Single Bond Universal Adhesive) in geriatric patients with Non-carious Cervical lesions (NCLLs)

Detailed Description
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To evaluate the clinical performance of a novel moisture resistant, M-TEG-P phosphate monomer based universal adhesive (YAMAKIN TMR-Aquabond0) compared to the conventional universal adhesive (3m ESPE Single Bond Universal Adhesive) in geriatric patients with Non-carious Cervical lesions (NCLLs) P: Population: Geriatric patients with non-carious cervical lesions (NCCLs) I: Intervention: Novel moisture resistant, M-TEG-P phosphate monomer based universal adhesive (YAMAKIN TMR-Aquabond0) C: Comparator : 3m ESPE Single Bond Universal Adhesive O: Outcome:Clinical Performance using FDI criteria

Official Title
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Clinical Performance of a Moisture Resistant, M-TEG-P Phosphate Monomer-based Universal Adhesive in Geriatric Patients With Non-carious Cervical Lesions (NCLLs):A Randomized Clinical Trial

Conditions
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Non-carious Cervical Lesions, Geriatric Patients

Intervention / Treatment
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* Other: Bonding in NCCLs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Non-carious cervical lesions in anterior and posterior teeth. Geriatric patients from age 60 years and above. Patients willing to commit to the whole period of the study. Males & Females included. Exclusion Criteria: Lack of written informed consent to participate Cervical hypersensitivities Underage patients Allergies to components of the materials used Infectious diseases Mucosal diseases with unclear diagnosis Inadequate oral hygiene Bruxism High caries activity Non-vital pulp Severe periodontal diseases Severe dysgnathia/traumatic occlusion Undergoing orthodontic treatments Undergoing bleaching procedures

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yamakin TMR-Aquabond0<br>Novel Moisture Resistant, M-TEG-P Phosphate Monomer Based Universal Adhesive (YAMAKIN TMR-Aquabond0) | Other: Bonding in NCCLs<br>* bonding agent which can resist moisture and has shorter decalcifying and curing time<br>|
| Active Comparator: 3m ESPE Single Bond Universal Adhesive<br>Conventional Universal Adhesive | Other: Bonding in NCCLs<br>* bonding agent which can resist moisture and has shorter decalcifying and curing time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of fractured restorations | First, visual inspection 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 there is no rocking /fracture /ditching in the restoration following FDI criteria ( first visually for total loss followed by tactile inspection using FDI probe for any fracture /rocking or loss of retention. | 12 months | 
| Number of restorations with retention loss | First, visual inspection 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 | 12 months | 

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 | 12 months | 
| Number of restoration caused biological harm | Evaluation will be done following FDI criteria using FDI probe to ensure there is no change in restoration that caused any harm to the health of biological structure | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-Carious cervical lesions