Clinical Performance of ARS Containing Universal Adhesives in Carious Cervical Lesions
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-67
SponsorCairo University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Vital teeth with carious cervical lesions in incisors , canines ,premolars& molars
Disqualifiers
Patients with fewer than 20 teeth
Poor oral hygiene
Uncontrolled periodontal disease
Xerostomia
Trial design
Design model
Parallel
Treatments tested in this trial
universal adhesive without Acid resistant silane coupling agent
Procedure/SurgeryAfter 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.
universal adhesive with Acid resistant silane coupling agent
Procedure/SurgeryAfter 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Universal adhesive without acid resistant silane coupling agentActive comparator 1 intervention
Group B: Universal adhesive with acid resistant silane coupling agentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Retention (Success rate)
Alpha (A) Present Bravo (B) Partial loss but clinically acceptable Charlie (C)Clinically unacceptable partial loss or absent
Time frame
T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.Secondary outcomes
1
Marginal adaptation
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.
Time frame
T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.2
Marginal discoloration
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.
Time frame
T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.3
Secondary caries
Alpha (A) No active caries present Charlie(C) Active caries is present in contact with the restoration
Time frame
T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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