Clinical Performance of ARS Containing Universal Adhesives in Carious Cervical Lesions

Clinical Performance of Universal Adhesive with and Without Acid Resistant Silane Coupling Agent in Carious Cervical Lesions :A Randomized Controlled 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cervical Caries; Carious Lesion
• Intervention / Treatment: Procedure: universal adhesive with Acid resistant silane coupling agent; Procedure: universal adhesive without Acid resistant silane coupling agent

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ahmed El-Kotaby, Master; Phone Number: Egypt +201150961970; Email: ahmed.elkotaby@dentistry.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Universal adhesive without acid resistant silane coupling agent; 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; 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.
Experimental: Universal adhesive with 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention (Success rate)	Alpha (A) Present Bravo (B) Partial loss but clinically acceptable Charlie (C)Clinically unacceptable partial loss or absent	T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: August 23, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: August 30, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Root Caries
• Other Study ID Numbers: CairoU ARS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No