Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06393699

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain shams university

Cairo, Egypt

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

composite restoration

Procedure

different types of resin composite restorations will be used to restore NCCL

Primary outcomes

  1. Retention

    Time frame: 18-24 months

    ability of resin composite restorations to be retained in the non carious cervical lesions

Secondary outcomes

  1. marginal staining

    Time frame: 18-24 months

    will be assessed visually by blinded evaluator

Other outcomes

  1. Marginal adaptation

    Time frame: 18-24 months

    will be assessed by explorer done by blinded evaluator

  2. postoperative sensitivity

    Time frame: 18-24 months

    will be assessed using triple way syringe with air done by blinded evaluator

Study contacts

Contact information is provided by the study sponsor or research team.

Aisha Elbaz

CONTACT

[email protected]

01156686680

Farid El-Askary

CONTACT

[email protected]

01002500177

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
May 1, 2024
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.