Clinical Evaluation of Short Dentin Etching
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age35-50
SponsorMansoura University
About this trial
To evaluate and compare the two-year clinical performance of Class I resin composite restorations utilizing a universal adhesive used in different etch-and-rinse strategies (15-second and 5-second etching) and self-etch strategies for bonding.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients with three primary occlusal caries of upper or lower posterior teeth.
Patients must have a good oral hygiene;
Patients with tooth gives a positive response to testing with an electric pulp tester
Patients with normal and full occlusion,
Disqualifiers
High caries risk patients with extremely poor oral hygiene
Patients involved in orthodontic treatment or periodontal surgery,
Patients with periodontally involved teeth (chronic
Trial design
Design model
Crossover
Treatments tested in this trial
Resin composite restoration bonded using universal adhesive in etch and rinse mode (15 seconds etching)
Procedure/SurgeryResin composite restoration bonded using universal adhesive in etch and rinse mode (15 seconds etching)
Resin composite restoration bonded using universal adhesive in etch and rinse mode (5 seconds etching)
Procedure/SurgeryResin composite restoration bonded using universal adhesive in etch and rinse mode (5 seconds etching)
Resin composite restoration bonded using universal adhesive in self-etch mode
Procedure/SurgeryResin composite restoration bonded using universal adhesive in self-etch mode
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Dentin etching and rinse (15 seconds etching)Placebo comparator 1 intervention
Group B: Dentin etching and rinse (5 seconds etching)Active comparator 1 intervention
Group C: Dentin self-etchPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Postoperative hypersensitivity/pulp status
The postoperative hypersensitivity/pulp status will be assessed based on the updated FDI criteria. This parameter is evaluated by scoring the pain experienced during chewing and/or with cold or warm food items, as reported by the patient. The criteria consist of five scores: scores 1-3 indicate success, score 4 indicates the need for restoration repair, and score 5 indicates the need for restoration replacement.
Time frame
Two years after restoration2
Marginal adaptation
The marginal adaptation will be evaluated through visual examination using a 250 µm probe and brief air drying. This assessment will be conducted according to the updated FDI criteria. The criteria consist of five scores: scores 1-3 indicate success, score 4 indicates the need for restoration repair, and score 5 indicates the need for restoration replacement.
Time frame
Two years after restorationSponsors and contacts
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Source ClinicalTrials.gov