Clinical trial NCT07003360: Clinical Evaluation of Bioactive Restorative Materials
Official title: Biofilm Inhibition and Remineralizing Potential of Bioactive Restorative Materials: Two-Year Randomized Clinical Trial in Class I Cavities
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Class I Dental Caries
Keywords: class I dental caries
bioactive materials
biofilm inhibition
remineralizing potential
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative hypersensitivity/pulp status
timeFrame: Two years after restoration
measure: Marginal adaptation
timeFrame: Two years after restoration]
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Dentistry, Mansoura University, Egypt
state: Dakahliya, Egypt,
Study officials:
References: