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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Number of fractured restorations
Study Overview
Brief Summary
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •High caries activity
- •Non-vital pulp
- •Severe periodontal diseases
- •Severe dysgnathia/traumatic occlusion
- •Undergoing orthodontic treatments
- •Undergoing bleaching procedures
Arms & Interventions
Yamakin TMR-Aquabond0
Novel Moisture Resistant, M-TEG-P Phosphate Monomer Based Universal Adhesive (YAMAKIN TMR-Aquabond0)
Intervention: Bonding in NCCLs (Other)
3m ESPE Single Bond Universal Adhesive
Conventional Universal Adhesive
Intervention: Bonding in NCCLs (Other)
Outcomes
Primary Outcomes
Number of fractured restorations
Time Frame: 12 months
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.
Number of restorations with retention loss
Time Frame: 12 months
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
Secondary Outcomes
- Number of restoration with change in colour or texture(12 months)
- Number of restoration caused biological harm(12 months)
Investigators
Hend Taha Hanafi Mahmoud
Resident in Conservative dentistry department , Cairo University
Cairo University