Carious Lesion, Cervical Caries
Conditions
Brief summary
Evaluation of composite restorations done in carious cervical lesions restored by a conventional universal adhesive in comparison to a universal adhesive that contains and resistant silane coupling agent according to the Modified United States Public Health Service (USPHS) criteria over 18 months.
Detailed description
The presence of acidic monomers in the bottle during storage can lead to the hydrolysis of silane contained in universal adhesives, potentially reducing its effectiveness and causing instability,The acid resistant silane coupling agent has a protective structure against attacks from acidic monomers. Therefore, long-term storage stability can be expected by suppressing hydrolysis. The protective structure is removed when the concentration of acidic monomers increases by air drying after application. This activates ARS, exerting the silane coupling effect.
Interventions
PROCEDUREuniversal adhesive without Acid resistant silane coupling agent
After cavity preparations, enamel margins will be etched for 30 seconds then rinsed and dried, then the Universal adhesive without acid resistant silane coupling agent will be actively applied for 20 seconds then air thinned for 5 seconds then cured for 20 seconds.Then the composite restoration will be placed.
PROCEDUREuniversal adhesive with Acid resistant silane coupling agent
After cavity preparations, enamel margins will be etched for 30 seconds then rinsed and dried, then the Universal adhesive which contains acid resistant silane coupling agent will be actively applied for 20 seconds then air thinned for 5 seconds then cured for 20 seconds.Then the composite restoration will be placed.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 67 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants Inclusion: • Adults aging from 21-67 years old who were in need of restoration of at least one notch-shaped cervical lesion * Teeth Inclusion: * Vital teeth with carious cervical lesions in incisors , canines ,premolars& molars
Exclusion criteria
* Participants Exclusion: * Patients with fewer than 20 teeth * Poor oral hygiene * Uncontrolled periodontal disease * Xerostomia * Known allergy to resin-based materials * Medically compromised, pregnant, or breast-feeding * Teeth Exclusion: * Non vital teeth * Teeth that are out of occlusion * Previously restored teeth
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Retention (Success rate) | T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative. | Alpha (A) Present Bravo (B) Partial loss but clinically acceptable Charlie (C)Clinically unacceptable partial loss or absent |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Marginal adaptation | T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative. | Alpha (A) Restoration adapts closely to the tooth structure; there is no visible crevice. Bravo (B) There is a visible crevice, the explorer will penetrate, without dentin exposure. Charlie(C)The explorer penetrates into a crevice in which dentin or the base is exposed. |
| Marginal discoloration | T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative. | Alpha (A) No marginal discoloration. Bravo (B) Minor marginal discoloration without staining toward the pulp, only visible using a mirror and operating light. Charlie(C) Deep discoloration with staining toward the pulp, visible at a speaking distance of 60 to 100 cm. |
| Secondary caries | T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative. | Alpha (A) No active caries present Charlie(C) Active caries is present in contact with the restoration |
Countries
Egypt
Contacts
Primary ContactAhmed El-Kotaby, Master
Outcome results
None listed