Bioactive Restorative Materials for Class II Restorations

NCT07552350 | Active Not Recruiting

• 1 other identifier: KA-24028
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized split-mouth clinical trial aims to evaluate the clinical performance of bioactive restorative materials used in Class II restorations in permanent posterior teeth. The study compares a giomer-based bulk-fill restorative material, a giomer restorative material, and a resin-modified glass ionomer cement in terms of clinical success and overall clinical performance. Patients requiring at least three Class II restorations in posterior teeth are treated under standardized clinical conditions. Clinical evaluations are performed at baseline and follow-up visits to assess short- and long-term outcomes.

Conditions

Class II Dental Caries; Bioactive Dental Restorative Materials

Keywords

Bioactive restorative materials; Class II restoration; Split-mouth trial; Giomer; Resin-modified glass ionomer cement

Outcome Measures

Primary Outcomes (5)

• Retention and fracture of restorations

  Retention and fracture of Class II restorations will be evaluated using modified FDI World Dental Federation criteria by a single examiner. Restorations will be scored based on the presence of loss of retention, fracture, or chipping. A score of 1 (excellent) or 2 (good) will be considered clinically successful.

  6 Months after restoration placement"

• Marginal adaptation of restorations

  Marginal adaptation will be assessed using modified FDI criteria by a single examiner. The presence of marginal gaps or discrepancies will be evaluated using visual inspection.

  6 Months after restoration placement"

• Surface luster of restorations

  Surface luster will be assessed using modified FDI criteria by a single examiner. The surface gloss and texture of restorations will be evaluated.

  6 Months after restoration placement"

• Postoperative sensitivity

  Postoperative sensitivity will be assessed using modified FDI criteria by a single examiner. Sensitivity will be evaluated based on clinical examination and patient-reported symptoms.

  6 Months after restoration placement"

• Secondary caries

  Secondary caries will be evaluated using clinical and radiographic examination according to modified FDI World Dental Federation criteria by a single examiner. Radiographic evaluation will be used to detect recurrent caries and any pathological findings adjacent to the restorations.

  6 Months after restoration placement"

Secondary Outcomes (1)

• Restoration survival

  12 and 24 months after restoration placement

Study Arms (3)

Giomer Restorative Material

EXPERIMENTAL

Class II posterior restorations restored with a giomer restorative material under standardized clinical conditions.

Device: Giomer Restorative Material

Giomer-Based Bulk-Fill Restorative Material

EXPERIMENTAL

Class II posterior restorations restored with a giomer-based bulk-fill restorative material under standardized clinical conditions.

Device: Giomer-Based Bulk-Fill Restorative Material

Resin-Modified Glass Ionomer Cement

EXPERIMENTAL

Class II posterior restorations restored with a resin-modified glass ionomer cement under standardized clinical conditions.

Device: Resin-Modified Glass Ionomer Cement

Interventions

Giomer Restorative Material DEVICE

Class II posterior restorations restored with a giomer restorative material according to the manufacturer's instructions under standardized clinical conditions.

Giomer Restorative Material

Giomer-Based Bulk-Fill Restorative Material DEVICE

Class II posterior restorations restored with a giomer-based bulk-fill restorative material according to the manufacturer's instructions under standardized clinical conditions.

Giomer-Based Bulk-Fill Restorative Material

Resin-Modified Glass Ionomer Cement DEVICE

Class II posterior restorations restored with a resin-modified glass ionomer cement according to the manufacturer's instructions under standardized clinical conditions.

Resin-Modified Glass Ionomer Cement

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy individuals without any systemic disease that could contraindicate restorative treatment
• Individuals aged between 18 and 50 years
• Individuals who agreed to participate in the study and signed the informed consent form
• Individuals with at least three proximal carious lesions in premolar or molar teeth, classified as D2 (lesions extending to the middle third of dentin) or D3 (lesions extending to the inner third of dentin) according to the ICDAS classification
• Teeth with intact enamel and dentin structure that had not been previously restored
• Individuals who brushed their teeth at least twice a day
• Individuals without physical disabilities that could prevent attendance at follow-up visits
• Individuals with at least 20 teeth in occlusion and with antagonist teeth in the opposing arch
• Vital teeth without signs of periapical pathology
• Periodontally healthy teeth that were not used as abutments for any prosthetic restoration
• Teeth without displacement or mobility
• Individuals who had undergone initial periodontal therapy

You may not qualify if:

• Pregnant or breastfeeding individuals
• Individuals with advanced periodontal disease
• Individuals using removable partial dentures
• Individuals with bruxism
• Individuals with severe malocclusion
• Individuals with known allergies to resin-based restorative materials or adhesive agents
• Individuals with a history of allergy to local anesthetics or their administration
• Individuals with latex allergy
• Individuals with poor oral hygiene
• Teeth that had been previously restored or were undergoing orthodontic treatment

Sponsors & Collaborators

• Hacettepe University: lead

Study Sites (1)

Hacettepe University Faculty of Dentistry, Department of Restorative Dentistry

Ankara, 06230, Turkey (Türkiye)

Location

Study Officials

• Elif Öztürk, PhD

  Hacettepe University Faculty of Dentistry, Department of Restorative Dentistry

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors were blinded to the restorative material assigned to each treatment site. The operator was aware of the material allocation during the restorative procedures.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant, Department of Restorative Dentistry

Model Details: This study uses a split-mouth design in which each participant receives different restorative materials in separate Class II cavities.

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 27, 2026
• Study Start: February 14, 2025
• Primary Completion: March 3, 2026
• Study Completion (Estimated): September 3, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Locations

TU (1)