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NCT Number: NCT07552350

Bioactive Restorative Materials for Class II Restorations

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.

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Key information

Conditions

Bioactive Dental Restorative Materials Class II Dental Caries

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hacettepe University Faculty of Dentistry, Department of Restorative Dentistry

Ankara, 06230, Turkey (Türkiye)

About this study

This is a single-center, randomized, controlled split-mouth clinical trial conducted at Hacettepe University Faculty of Dentistry. The aim of the study is to compare the clinical performance of bioactive restorative materials used in Class II posterior restorations.

Eligible patients requiring at least three Class II restorations in permanent posterior teeth are included in the study. Each patient receives restorations with different bioactive restorative materials in separate treatment sites according to a split-mouth design. The tested materials include a giomer-based bulk-fill restorative material, a giomer restorative material, and a resin-modified glass ionomer cement. Randomization is used to assign the restorative materials to the treatment sites.

All restorative procedures are performed under standardized clinical protocols. Clinical performance is evaluated using modified FDI criteria.

Follow-up evaluations are planned at 6, 12, and 24 months after treatment. The 6-month results are used for interim analysis, while long-term follow-up will assess the durability and clinical success of the restorative materials.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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-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.

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.

Primary outcomes

  1. Retention and fracture of restorations

    Time frame: 6 Months after restoration placement"

    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.

  2. Marginal adaptation of restorations

    Time frame: 6 Months after restoration placement"

    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.

  3. Surface luster of restorations

    Time frame: 6 Months after restoration placement"

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

  4. Postoperative sensitivity

    Time frame: 6 Months after restoration placement"

    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.

  5. Secondary caries

    Time frame: 6 Months after restoration placement"

    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.

Secondary outcomes

  1. Restoration survival

    Time frame: 12 and 24 months after restoration placement

    Restoration survival will be evaluated at 12 and 24 months based on the presence of restorations in function without the need for repair or replacement. Failures will include restoration loss, fracture requiring replacement, or the presence of secondary caries leading to restoration replacement.

Sponsors and collaborators

Lead sponsor

Hacettepe University

Other

Registry information

Official study title

Evaluation of Bioactive Dental Restorative Materials in Class II Restorations: A Controlled Randomized Split-Mouth Study

Acronym: BIO-CLASS II

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 27, 2026
Registry last updated
Apr 27, 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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