Clinical Evaluation of Bioactive Restorative Materials

Not Applicable

Active, not recruiting

• Conditions: Class I Dental Caries

• Registration Number: NCT07003360
• Lead Sponsor: Mansoura University

Brief Summary

The objectives of this study are to evaluate and compare the biofilm inhibition and re-mineralizing potential at tooth restoration interface and their 2-year clinical performance in class I cavities.The patients will be selected from the Outpatient clinic at Faculty of Dentistry, Mansoura University. Patients will be informed about the steps of the study, whom will approve, will sign a written consent form. The form and protocol will be approved by the Ethics Committee. Each patient should have 4 frank carious dentinal lesions (ICDAS score 4 or 5) in posterior teeth. A periapical radiograph will be performed to evaluate the extension of the carious lesion and to ensure that there is no radiolucency in the periapical or furcation area. The teeth have to be vital, not sensitive to percussion and/or spontaneous pain. The patients will be required to have complete and normal occlusion as well as good oral hygiene.

Detailed Description

This study will be intended to evaluate and compare the biofilm inhibition and re-mineralizing potential at tooth restoration interface and their 2-year clinical performance in class I cavities.

Null hypothesis This study will be designed to test the null hypothesis that there will be no significant difference in neither biofilm inhibition nor remineralizing potential at tooth-restoration interface of the used tested materials. Also, that there will be no significant difference in the 2-year clinical outcomes of the bioactive restorative materials in class I cavities.

Sample size calculation was based on clinical performance according to FDI criteria between different bioactive restorative materials that was retrieved from previous research.19 Using G power program version 3.1.9.7 to calculate sample size, using 2-tailed test, α error =0.05 and power = 80%, the total calculated sample size will be 30 cases at least in each group Patient selection The patients will be selected from the Outpatient clinic at Faculty of Dentistry, Mansoura University. Patients will be informed about the steps of the study, whom will approve, will sign a written consent form. The form and protocol will be approved by the Ethics Committee. Each patient should have 4 frank carious dentinal lesions (ICDAS score 4 or 5) in posterior teeth. A periapical radiograph will be performed to evaluate the extension of the carious lesion and to ensure that there is no radiolucency in the periapical or furcation area. The teeth have to be vital, not sensitive to percussion and/or spontaneous pain. The patients will be required to have complete and normal occlusion as well as good oral hygiene.

Study Design:

The total number of patients will be 30 patients. Each patient will receive restorative materials studied in this investigation.

Clinical procedures All restorations will be done by a single experienced operator and with proper magnification aids. The restorative procedures will be performed under local anesthesia and rubber dam isolation. Cavity preparations for resin composite restoration will be prepared using high speed handpiece.

Evaluation procedures All restorations will be clinically evaluated immediately after finishing and polishing (baseline), 6 months, 12 months, 18 months and finally after 24 months by two independent examiners. If any restoration failed, repair or replacement of the restoration will be considered.

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-03-02
• Study First Submitted: 2025-05-12
• Study First Submitted QC: 2025-05-25
• Last Update Submitted: 2025-05-25
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04
• Primary Completion: 2026-11-02
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with four primary occlusal caries of upper or lower posterior teeth.

  • Patients must have a good oral hygiene;
  • Patients with tooth gives a positive response to testing with an electric pulp tester
  • Patients with normal and full occlusion,
  • Patients with opposing teeth should be natural with no restorations.

Exclusion Criteria

• • High caries risk patients with extremely poor oral hygiene

  • Patients involved in orthodontic treatment or periodontal surgery,
  • Patients with periodontally involved teeth (chronic

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Postoperative hypersensitivity/pulp status	Two years after restoration	Postoperative hypersensitivity/pulp status.The postoperative hypersensitivity/pulp status will be assessed based on the updated FDI criteria; - Intensity was assessed with Visual Analogue Scale. Postoperative sensitivity was evaluated by blowing a stream of compressed air for 3 seconds at a distance of 2-3 cm from the restoration. -Vitality was tested with application of cold (dry ice) and compared the reaction with the adjacent vital teeth . This parameter is evaluated by scoring the pain experienced during chewing and/or with cold or warm food items, as reported by the patient. The criteria consist of five scores: scores 1-3 indicate success, score 4 indicates the need for restoration repair, and score 5 indicates the need for restoration replacement.
Marginal adaptation	Two years after restoration]	The marginal adaptation will be evaluated through visual examination using a - A magnifying aid (loupe 4.5 x) was used for evaluation. Two special probes with different blunt tips (150 and 250 μm). This assessment will be conducted according to the updated FDI criteria. The criteria consist of five scores: scores 1- 3 indicate success, score 4 indicates the need for restoration repair, and score 5 indicates the need for restoration replacement.

Trial Locations

Locations (1)

Faculty of Dentistry, Mansoura University, Egypt; 🇪🇬 Mansoura, Dakahliya, Egypt,, Egypt