Clinical Performance of ARS Containing Universal Adhesives in Carious Cervical Lesions

Not Applicable

Not yet recruiting

• Conditions: Cervical Caries; Carious Lesion

• Registration Number: NCT06572124
• Lead Sponsor: Cairo University

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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-23
• Study First Submitted QC: 2024-08-23
• Study First Posted: 2024-08-26
• Last Update Submitted: 2024-08-26
• Last Update Posted: 2024-08-28
• Study Start: 2024-09-01
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.