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NCT Number: NCT07561216

Injectable Bioactive Composites vs RMGI for Proximal Cavities in Primary Molars

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.

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Key information

Age range

3 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Secondary Caries

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

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

Secondary outcomes

  1. Postoperative sensitivity / pulp status

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

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

  2. Marginal Adaptation

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

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

  3. Proximal Contact Point

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

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

  4. Occlusal Wear

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

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

  5. Fracture and Retention

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

    Presence of cracks, fractures, or loss of restoration assessed using revised FDI criteria (F1), scored 1-5

Study contacts

Contact information is provided by the study sponsor or research team.

Dina Mohamed

CONTACT

[email protected]

Nadine Elsayed Ahmed Elshayal

CONTACT

[email protected]

01069995861

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Acronym: GIOMER-RCT

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 1, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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