Menu
Not yet recruiting NCT07561216

Injectable Bioactive Composites vs RMGI for Proximal Cavities in Primary Molars

No phase Interventional Dental Caries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: giomer, RMGI.
Who it may be relevant to
Registry conditions: Dental Caries. Basic parameters: 3 years — 8 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Evaluation of Injectable Bioactive Composites Versus Resin Modified Glass Ionomer for Restoring Proximal Cavities in Primary Molars: A Randomized Clinical Tria

Overview

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.

Detailed description

Dental caries remains the most prevalent chronic disease in children. The choice of restorative material for primary teeth significantly impacts treatment outcomes and longevity. This study compares two fluoride-releasing restorative materials in proximal cavities of primary molars.

Eligible children aged 3-8 years with ICDAS 3 or 4 proximal carious lesions in primary molars will be randomly allocated into two equal groups (24 teeth each):

Group I (Intervention): Restoration with injectable bioactive giomer (Beautifil Flow Plus X F00, Shofu) using BeautiBond Xtreme adhesive Group II (Control): Restoration with Resin Modified Glass Ionomer (RMGI)

Restorations will be clinically evaluated at baseline, 3, 6, and 12 months using revised FDI criteria assessing biological properties (secondary caries, sensitivity, tooth integrity), functional properties (marginal adaptation, proximal contact, occlusal wear, fracture/retention), and aesthetic properties.

Interventions

  • Other giomer
    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.
  • Other RMGI
    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.

Primary outcome measures

  • Secondary Caries [Time frame: Baseline, 3, 6, and 12 months]
Secondary outcome measures (5)
  • Postoperative sensitivity / pulp status [Time frame: Baseline, 3, 6, and 12 months]
  • Marginal Adaptation [Time frame: Baseline, 3, 6, and 12 months]
  • Proximal Contact Point [Time frame: Baseline, 3, 6, and 12 months]
  • Occlusal Wear [Time frame: Baseline, 3, 6, and 12 months]
  • Fracture and Retention [Time frame: Baseline, 3, 6, and 12 months]

Eligibility criteria

Inclusion criteria

  • Children aged 3-8 years of both genders
  • Cooperative behavior manageable by operators
  • Willing to sign informed consent
  • Accepts the follow-up period
  • Moderate to low caries risk according to Cariogram application
  • Posterior primary molar with proximal carious lesion (ICDAS 3 or 4) with no signs or symptoms of pulpal involvement
  • Radiographically extending to outer 1/3 of dentin

Exclusion criteria

  • Allergy to any restorative materials
  • Patients undergoing orthodontic treatment with fixed appliances
  • Patients with debilitating systemic diseases
  • Children with special needs
  • Teeth with previous restorations
  • Periapical radiolucencies or sensitivity to percussion
  • Mobile teeth
  • External or internal resorption
  • Cervical carious lesions

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07561216 · CairoU-Injectable VS RMGI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗