Clinical trial NCT05029479: 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)
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-carious Cervical Lesions
Geriatric Patients
Keywords: Non-Carious cervical lesions
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-08-31
Enrollment: 28
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of fractured restorations
timeFrame: 12 months
measure: Number of restorations with retention loss
timeFrame: 12 months
Secondary outcomes:
measure: Number of restoration with change in colour or texture
timeFrame: 12 months
measure: Number of restoration caused biological harm
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry , Cairo University
Study officials:
References:
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