Restoration of Non-carious Cervical Lesions With Different Resin Composites and Universal Adhesive

Restoration of Non-carious Cervical Lesions: The Effect of Different Resin Composites Bonded With A Universal Adhesive Utilizing Two Adhesion Approaches: A Randomized Clinical Study

patients with non carious cervical lesions suffer from dentin sensitivity and presence of cavitations and gingival recession. Restoring these lesions with different composites and evaluation of restorations every 6 months will be done to know the effect of different composite types and consistencies in retention of restorations of such lesions.

Study Overview

• Status: Recruiting
• Conditions: Retention
• Intervention / Treatment: Procedure: composite restoration

Detailed Description

A split-mouth randomized clinical trial (RCT), based on the adhesion strategy, will be held on 52 patients attending to the outpatient clinics of the department of operative dentistry, Faculty of Dentistry, Ain Shams University with 2 non-carious cervical lesions in each side. Patients included in this study are those who seek restorative treatment of non-carious cervical lesions (NCCLs) in premolars and canines, which are due to chemical and/or mechanical predisposing factors. An informed consent will be signed by all participants who will be allocated in this study before being involved in the study. Male and female patients will be selected according to the inclusion and exclusion criteria. The patients will be randomly assigned into 4 main groups (n=13 patients/group) according to the type of restorative material will be inserted. In each group, two adhesive approaches will be employed, either etch-and-rinse (E&R) or self-etching (SE)approach. For each patient's mouth, one side will receive restorations with the etch-and-rinse approach (n=26 restorations/E&R approach), while the other side will receive restorations using the self-etching approach (n=26 restorations/SE approach). This will result in a total of 208 restorations will be inserted in this study. A treatment follow-up will be performed every six months for two years to investigate the clinical performance of the different resin composite restorations/the two different adhesive approaches.

Restorations will be evaluated at baseline and every 6 months by two blinded examiners, who will not be involved in the study. During evaluation, the examiners will not be informed about the type of restoration used or the adhesive approach and will have a code for each patient and the restored tooth. Restorations will be evaluated according to the modified United State Public Health Service criteria (USPHS).(6,9,13,30) Primary outcome will be the retention of the restoration, but the following secondary outcomes as marginal discoloration and adaptation, anatomic form, secondary caries, texture, and postoperative sensitivity will be also evaluated.

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aisha Elbaz; Phone Number: 01156686680; Email: aishareda@dent.asu.edu.eg
• Study Contact Backup: Name: Farid El-Askary; Phone Number: 01002500177; Email: faridelaskary@asfd.asu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • Ain shams university

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

- Patients' age will range from 18 to 65 years.

• Presence of at least 2 NCCLs in one side.
• Patients with no medical condition could interfere with the routine dental care.
• Patients who will be able to attend for each recall visit.
• Patients with healthy periodontal tissues.
• Cavities presenting no more than 50% of margins in enamel.

Exclusion Criteria:

• Medically compromised patients.

  • Pregnant or breast-feeding patients.
  • Patients undergoing orthodontic treatment or bleaching treatment in the time of the study.
  • Patients with periodontal disease in the target area.
  • Patients presented with less than 20 teeth in the oral cavity.
  • Patients without antagonists.
  • Lesions superimposed with caries

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: incremental; application of increments of packable composite in non carious cervical lesions	Procedure: composite restoration; different types of resin composite restorations will be used to restore NCCL
Experimental: bulk fill heated; application of heated composite as bulk in the lesions without incrementation after heating with caps warmer	Procedure: composite restoration; different types of resin composite restorations will be used to restore NCCL
Experimental: incremental heated; application of composite in increments after being heated by caps warmer	Procedure: composite restoration; different types of resin composite restorations will be used to restore NCCL
Experimental: flowable; application of flowable composite in non carious cervical lesions	Procedure: composite restoration; different types of resin composite restorations will be used to restore NCCL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention	ability of resin composite restorations to be retained in the non carious cervical lesions	18-24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
marginal staining	will be assessed visually by blinded evaluator	18-24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal adaptation	will be assessed by explorer done by blinded evaluator	18-24 months
postoperative sensitivity	will be assessed using triple way syringe with air done by blinded evaluator	18-24 months

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2022
• Primary Completion (Estimated): December 14, 2025
• Study Completion (Estimated): December 30, 2026

Study Registration Dates

• First Submitted: August 29, 2023
• First Submitted That Met QC Criteria: April 26, 2024
• First Posted (Actual): May 1, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 969

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: expecting to have all data by october 2026
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No