Image

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

Recruiting
18 - 65 years of age
Both
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

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 details

Retention of Restorations

NCT06393699

Ain Shams University

14 May 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.