Geriatric Patients, Non-carious Cervical Lesions
Conditions
Keywords
Non-Carious cervical lesions
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
Interventions
OTHERBonding in NCCLs
bonding agent which can resist moisture and has shorter decalcifying and curing time
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of fractured restorations | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of restoration with change in colour or texture | 12 months | Evaluation will be done visually following FDI criteria to ensure no change in colour or texture of the restoration |
| Number of restoration caused biological harm | 12 months | 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 |
Countries
Egypt
Outcome results
None listed