Health TrialsbyHealthPanel

The Effectiveness RMGI and Giomer, Individually and Combined Anterior Cervical Caries

ConditionsDental CariesCervical Caries
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-55
SponsorCairo University

About this trial

This study compares the effectiveness of three dental materials for restoring anterior cervical caries in high-risk patients: resin-modified glass ionomer (RMGI), Giomer, and a combination technique where RMGI is veneered with Giomer. The 18-month randomized clinical trial will assess 75 patients (25 per group), primarily evaluating secondary caries formation, with additional measurements of restoration integrity, appearance, and sensitivity at baseline, 6, 12, and 18 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient age range from 18-55 years

Presence of anterior cervical caries on the labial surface (ICDAS 4 & 5)

High caries risk

Good general health

Disqualifiers

Severe or chronic periodontal disease

Bruxism

Non-vital teeth

Fractured or cracked teeth

Trial design

Design model

Parallel

Treatments tested in this trial

  • Low shrinkage Giomer restorative material (Beautifil II LS)

    Procedure/Surgery

    Enamel margins are etched with 37% phosphoric acid for 15 seconds, then the cavity is bonded using FL bond two-step self-etch adhesive. Giomer is applied in increments (maximum 2mm thickness) and light-cured for 20 seconds with a properly calibrated LED curing light.

  • RMGI alone - Control

    Procedure/Surgery

    Cavities will be restored with light-cured resin modified glass ionomer (GC Fuji II LC) only. After applying conditioner for 20 seconds, rinsing, and gentle drying, the RMGI will fill the entire cavity and be light-cured

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Group 2 (RMGI + Giomer Lamination)Experimental treatment 1 intervention
Group B: Group 3 (RMGI alone - Control)Active comparator 1 intervention
Group C: Group 1 (Giomer)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Secondary Caries

The methodology includes visual examination, short air drying, and the use of a 250-μm probe to assess for the presence of secondary caries around the restorations.

Time frame
6 months
2

Secondary Caries

The methodology includes visual examination, short air drying, and the use of a 250-μm probe to assess for the presence of secondary caries around the restorations.

Time frame
12 months
3

Secondary Caries

The methodology includes visual examination, short air drying, and the use of a 250-μm probe to assess for the presence of secondary caries around the restorations.

Time frame
18 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: