CClinicalTrials.gg
RecruitingNCT06393699Updated Feb 27, 2025

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

An interventional study of composite restoration in Retention, sponsored by Ain Shams University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-27.

Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 3 months after the study started (first participant enrolled May 2022, registered Aug 2023).
  • Started May 2022; still recruiting 4 years 4 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Retention
03

In context

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
52 participants (estimated)

Study arms

  • Experimental
    incremental

    application of increments of packable composite in non carious cervical lesions

    Procedure: composite restoration

  • Experimental
    bulk fill heated

    application of heated composite as bulk in the lesions without incrementation after heating with caps warmer

    Procedure: composite restoration

  • Experimental
    incremental heated

    application of composite in increments after being heated by caps warmer

    Procedure: composite restoration

  • Experimental
    flowable

    application of flowable composite in non carious cervical lesions

    Procedure: composite restoration

Interventions

  • Procedurecomposite restoration

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

06

What researchers measure

Primary outcomes

  1. Retention

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

    Time frame: 18-24 months

Secondary outcomes

  1. marginal staining

    will be assessed visually by blinded evaluator

    Time frame: 18-24 months

Other outcomes

  1. Marginal adaptation

    will be assessed by explorer done by blinded evaluator

    Time frame: 18-24 months

  2. postoperative sensitivity

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

    Time frame: 18-24 months

07

Study locations

1 of 1 sites recruiting
  • Ain shams university
    Cairo, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06393699
Lead sponsor
Ain Shams University
Responsible party
Aisha Ahmed Elbaz (Principle investigator, Ain Shams University) — Principal investigator
First posted
May 1, 2024
Start date
May 14, 2022
Primary completion
Dec 14, 2025 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
Feb 27, 2025

Study contacts

Aisha Elbaz
Contact
aishareda@dent.asu.edu.eg
01156686680
Farid El-Askary
Contact
faridelaskary@asfd.asu.edu.eg
01002500177

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion