Clinical Performance of ARS Containing Universal Adhesives in Carious Cervical Lesions

NCT06572124 | Not Yet Recruiting

• 1 other identifier: CairoU ARS
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Carious Lesion; Cervical Caries

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Marginal adaptation

  T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.

• Marginal discoloration

  T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.

• Secondary caries

  T0=baseline 24 hours postoperative. T1=12 months postoperative. T2=18 months postoperative.

Study Arms (2)

Universal adhesive without acid resistant silane coupling agent

ACTIVE COMPARATOR

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

EXPERIMENTAL

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

Interventions

universal adhesive without Acid resistant silane coupling agent PROCEDURE

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.

Universal adhesive without acid resistant silane coupling agent

universal adhesive with Acid resistant silane coupling agent PROCEDURE

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.

Universal adhesive with acid resistant silane coupling agent

Eligibility Criteria

• Age: 21 Years - 67 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aging from 21-67 years old who were in need of restoration of at least one notch-shaped cervical lesion
• Vital teeth with carious cervical lesions in incisors , canines ,premolars\& molars

You may not qualify if:

• 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
• Non vital teeth
• Teeth that are out of occlusion
• Previously restored teeth

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Dental Caries; Root Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Ahmed El-Kotaby, Master

CONTACT

Egypt +201150961970; ahmed.elkotaby@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal investigator

Study Record Dates

• First Submitted: August 23, 2024
• First Posted: August 26, 2024
• Study Start: September 1, 2024
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)