Injectable Bioactive Composites vs RMGI for Proximal Cavities in Primary Molars

NCT07561216 | Not Yet Recruiting DMC

• 1 other identifier: CairoU-Injectable VS RMGI
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Dental Caries

Keywords

Randomized Clinical Trial; Primary Dentition; Giomer; RMGI; FDI criteria

Outcome Measures

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.

  Baseline, 3, 6, and 12 months

Secondary Outcomes (5)

• Postoperative sensitivity / pulp status

  Baseline, 3, 6, and 12 months

• Marginal Adaptation

  Baseline, 3, 6, and 12 months

• Proximal Contact Point

  Baseline, 3, 6, and 12 months

• Occlusal Wear

  Baseline, 3, 6, and 12 months

• Fracture and Retention

  Baseline, 3, 6, and 12 months

Study Arms (2)

RMGIC

ACTIVE COMPARATOR

cavity restorations in primary molars using a resin-modified glass ionomer cement. Following standard cavity preparation, the RMGI material will be placed according to the manufacturer's instructions. Clinical performance will be evaluated over the follow-up period in terms of restoration retention, marginal adaptation, secondary caries, postoperative sensitivity, and overall clinical success.

Other: giomer

giomer

EXPERIMENTAL

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

Interventions

giomer OTHER

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.

RMGIC

RMGI OTHER

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.

giomer

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Nadine Elshayal

  Cairo University

  PRINCIPAL INVESTIGATOR

• Dina Ez Mohamed

  Cairo University

  PRINCIPAL INVESTIGATOR

• Osama Elshahawy

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Nadine Elsayed Ahmed Elshayal

CONTACT

01069995861; nadine.elshayal@dentistry.cu.edu.eg

Dina Mohamed

CONTACT

dina.ezz@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding of operators, patients, parents and outcome assessors was not possible as both materials differ in appearance and application technique.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's Student

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: May 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share