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Injectable Bioactive Composites vs RMGI for Proximal Cavities in Primary Molars

ConditionDental Caries
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-8
SponsorCairo University

About this trial

This randomized clinical trial aims to evaluate and compare the clinical performance of injectable bioactive composite (Beautifil Flow Plus X, Shofu) versus Resin Modified Glass Ionomer (RMGI) in restoring proximal cavities (Class II) in primary molars of children aged 3-8 years over a 12-month follow-up period, using revised FDI criteria.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children aged 3-8 years of both genders

Cooperative behavior manageable by operators

Willing to sign informed consent

Accepts the follow-up period

Disqualifiers

Allergy to any restorative materials

Patients undergoing orthodontic treatment with fixed appliances

Patients with debilitating systemic diseases

Children with special needs

Trial design

Design model

Parallel

Treatments tested in this trial

  • giomer

    Other intervention

    restoration of proximal cavities in primary molars using an injectable bioactive composite (Giomer) material. Cavities will be prepared following minimally invasive principles, isolated appropriately, and restored according to the manufacturer's instructions using adhesive bonding. Clinical performance will be evaluated in terms of retention, marginal adaptation, secondary caries, postoperative sensitivity, and overall restoration success during the follow-up period.

  • RMGI

    Other intervention

    Resin-Modified Glass Ionomer (RMGI) is a fluoride-releasing restorative material used for the restoration of carious primary teeth. It combines the properties of conventional glass ionomer cement with resin components to improve mechanical strength, adhesion, and moisture tolerance. In this study, RMGI will be used for restoring cavitated carious lesions in primary teeth following caries removal according to minimally invasive dentistry principles.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: RMGICActive comparator 1 intervention
Group B: giomerExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Secondary Caries

Assessed using revised FDI criteria (B1: caries at restoration margin). Evaluated by visual examination and short air drying. Scored on ordinal scale 1-5.

Time frame
Baseline, 3, 6, and 12 months

Secondary outcomes

1

Postoperative sensitivity / pulp status

Presence of caries at restoration margin assessed by visual examination using revised FDI criteria (B1), scored 1-5.

Time frame
Baseline, 3, 6, and 12 months
2

Marginal Adaptation

Quality of marginal seal between restoration and tooth structure assessed using revised FDI criteria (F2), scored 1-5.

Time frame
Baseline, 3, 6, and 12 months
3

Proximal Contact Point

Presence and quality of proximal contact between restored tooth and adjacent tooth assessed using revised FDI criteria (F3), scored 1-5

Time frame
Baseline, 3, 6, and 12 months
4

Occlusal Wear

Degree of wear of restoration surface under occlusal loading assessed using revised FDI criteria (F5), scored 1-5

Time frame
Baseline, 3, 6, and 12 months

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: