An interventional study of universal adhesive without Acid resistant silane coupling agent and universal adhesive with Acid resistant silane coupling agent in Carious Lesion and Cervical Caries, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 21 Years to 67 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-04.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
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.
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.
39 studies on the registry are indexed under Root Caries; 14 are open to participants now.
This study's planned enrollment of 80 is above the median of 62 across 35 interventional studies indexed under Root Caries.
Browse Root Caries studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
Compared within Root Caries, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Dental Caries. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants Inclusion:
Teeth Inclusion:
Exclusion Criteria:
Participants Exclusion:
Teeth Exclusion:
Universal adhesive with normal silane (comparator) After the acid etching and rinsing and drying step, the universal adhesive with normal silane will be actively applied for 20 second , then light cured for 20 seconds then the restoration will be placed
Procedure: universal adhesive without Acid resistant silane coupling agent
Universal adhesive with acid resistant silane coupling agent (Intervention) After the acid etching and rinsing and drying step, the universal adhesive with acid resistant silane coupling agent will be actively applied for 20 second , then light cured for 20 seconds then the restoration will be placed
Procedure: universal 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 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.
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.
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.
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.
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.
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.
Plan to share: No
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This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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