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)

Cairo University28 enrolled

Overview

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)

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Non-carious Cervical Lesions Geriatric Patients

Interventions

Eligibility

Sex: ALLMin age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Non-carious cervical lesions in anterior and posterior teeth. 2. Geriatric patients from age 60 years and above. 3. Patients willing to commit to the whole period of the study. 4. Males \& Females included. Exclusion Criteria: 1. Lack of written informed consent to participate 2. Cervical hypersensitivities 3. Underage patients 4. Allergies to components of the materials used 5. Infectious diseases 6. Mucosal diseases with unclear diagnosis 7. Inadequate oral hygiene 8. Bruxism 9. High caries activity 10. Non-vital pulp 11. Severe periodontal diseases 12. Severe dysgnathia/traumatic occlusion 13. Undergoing orthodontic treatments 14. Undergoing bleaching procedures

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 12 months

Secondary Outcomes

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

Time frame: 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

Time frame: 12 months

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)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes