Clinical Evaluation of Bioactive Restorative Materials

NCT ID: NCT07003360

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-02
• Study Completion Date: 2027-12-30

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.

Conditions

Class I Dental Caries

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

application of beautiful blukfill II shofu composite

Operative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece . Cavities were prepared following common principles for moderate to large class I adhesive resin composite restorations.

cavities without a liner, beautiful blukfill II shofu composite were placed in bulk (a maximum 4mm thickness layer) with manual filling instruments and burnishers and cured for 40 seconds. Occlusal adjustments were performed using fine grit yellow-coded tapered with round ends and flame-shaped diamond stones (Komet, USA).

Polishing was done using rubber points and polishing brushes (Occlubrush, Kerr, Switzerland) operated at low-speed with water coolant and minimal pressure.

Group Type: ACTIVE_COMPARATOR

application of beautiful blukfill II shofu composite

Intervention Type: PROCEDURE

Operative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece. Remaining infected carious dentin was excavated using a hand excavator. Cavities were finished using fine grit yellow-coded tapered diamond stones. 37% phosphoric acid gel was applied for 15 seconds on enamel margins, rinsed with water for 15 seconds and cavities were air-dried with Teflon protection on dentin. Self-etching universal adhesive was actively rubbed on cavity surfaces. Light curing was performed for 20 seconds. In cavities without a liner, beautiful bluk fill II composite were placed in bulk (maximum 4mm thickness layer) and cured for 40 seconds, Occlusal adjustments were performed.

application of Ivoclar vivadent bulkfill composite

Operative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece .Cavities were prepared following common principles for moderate to large class I adhesive resin composite restorations.

cavities without a liner, Ivoclar vivadent bulkfill composite were placed in bulk (maximum 4mm thickness layer) with manual filling instruments and burnishers, and cured for 40 seconds ,Occlusal adjustments were performed using fine grit yellow-coded tapered with round end and flame-shaped diamond stones (Komet, USA).

Polishing was done using rubber points and polishing brushes (Occlubrush, Kerr, Switzerland) operated at low-speed with water coolant and minimal pressure.

Group Type: ACTIVE_COMPARATOR

application of Ivoclar vivadent bulkfill composite

Intervention Type: PROCEDURE

Operative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece. Remaining infected carious dentin was excavated using a hand excavator. Cavities were finished using fine grit yellow-coded tapered diamond stones. 37% phosphoric acid gel was applied for 15 seconds on enamel margins, rinsed with water for 15 seconds and cavities were air-dried with Teflon protection on dentin. Self-etching universal adhesive was actively rubbed on cavity surfaces. Light curing was performed for 20 seconds. In cavities without a liner, Ivoclar vivadent bulkfill composite were placed in bulk (maximum 4mm thickness layer) and cured for 40 seconds, Occlusal adjustments were performed.

application of Predicta bulk fill composite

Operative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece .Cavities were prepared following common principles for moderate to large class I adhesive resin composite restorations.

cavities without a liner, Predicta bulk fill composite were placed in bulk (maximum 4mm thickness layer) with manual filling instruments and burnishers, and cured for 40 seconds ,Occlusal adjustments were performed using fine grit yellow-coded tapered with round end and flame-shaped diamond stones (Komet, USA).

Polishing was done using rubber points and polishing brushes (Occlubrush, Kerr, Switzerland) operated at low-speed with water coolant and minimal pressure.

Group Type: ACTIVE_COMPARATOR

application of Predicta bulk fill composite

Intervention Type: PROCEDURE

Operative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece. Remaining infected carious dentin was excavated using a hand excavator. Cavities were finished using fine grit yellow-coded tapered diamond stones. 37% phosphoric acid gel was applied for 15 seconds on enamel margins, rinsed with water for 15 seconds and cavities were air-dried with Teflon protection on dentin. Self-etching universal adhesive was actively rubbed on cavity surfaces. Light curing was performed for 20 seconds. In cavities without a liner, Predicta bulk fill composite were placed in bulk (maximum 4mm thickness layer) and cured for 40 seconds, Occlusal adjustments were performed

application of Stela self-cure bulk fill composite

Operative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece .Cavities were prepared following common principles for moderate to large class I adhesive resin composite restorations.

cavities without a liner, Stela self-cure bulk fill composite placed in bulk (maximum 4mm thickness layer) with manual filling instruments and burnishers, and cured for 40 seconds , Occlusal adjustments were performed using fine grit yellow-coded tapered with round end and flame-shaped diamond stones (Komet, USA).

Polishing was done using rubber points and polishing brushes (Occlubrush, Kerr, Switzerland) operated at low-speed with water coolant and minimal pressure.

Group Type: ACTIVE_COMPARATOR

application of Stela self-cure bulk fill composite

Intervention Type: PROCEDURE

Operative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece. Remaining infected carious dentin was excavated using a hand excavator. Cavities were finished using fine grit yellow-coded tapered diamond stones. 37% phosphoric acid gel was applied for 15 seconds on enamel margins, rinsed with water for 15 seconds and cavities were air-dried with Teflon protection on dentin. Self-etching universal adhesive was actively rubbed on cavity surfaces. Light curing was performed for 20 seconds. In cavities without a liner, Stela self-cure bulk fill composite were placed in bulk (maximum 4mm thickness layer) and cured for 40 seconds, Occlusal adjustments were performed.

Interventions

application of beautiful blukfill II shofu composite

Operative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece. Remaining infected carious dentin was excavated using a hand excavator. Cavities were finished using fine grit yellow-coded tapered diamond stones. 37% phosphoric acid gel was applied for 15 seconds on enamel margins, rinsed with water for 15 seconds and cavities were air-dried with Teflon protection on dentin. Self-etching universal adhesive was actively rubbed on cavity surfaces. Light curing was performed for 20 seconds. In cavities without a liner, beautiful bluk fill II composite were placed in bulk (maximum 4mm thickness layer) and cured for 40 seconds, Occlusal adjustments were performed.

Intervention Type: PROCEDURE

application of Ivoclar vivadent bulkfill composite

Operative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece. Remaining infected carious dentin was excavated using a hand excavator. Cavities were finished using fine grit yellow-coded tapered diamond stones. 37% phosphoric acid gel was applied for 15 seconds on enamel margins, rinsed with water for 15 seconds and cavities were air-dried with Teflon protection on dentin. Self-etching universal adhesive was actively rubbed on cavity surfaces. Light curing was performed for 20 seconds. In cavities without a liner, Ivoclar vivadent bulkfill composite were placed in bulk (maximum 4mm thickness layer) and cured for 40 seconds, Occlusal adjustments were performed.

Intervention Type: PROCEDURE

application of Predicta bulk fill composite

Operative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece. Remaining infected carious dentin was excavated using a hand excavator. Cavities were finished using fine grit yellow-coded tapered diamond stones. 37% phosphoric acid gel was applied for 15 seconds on enamel margins, rinsed with water for 15 seconds and cavities were air-dried with Teflon protection on dentin. Self-etching universal adhesive was actively rubbed on cavity surfaces. Light curing was performed for 20 seconds. In cavities without a liner, Predicta bulk fill composite were placed in bulk (maximum 4mm thickness layer) and cured for 40 seconds, Occlusal adjustments were performed

Intervention Type: PROCEDURE

application of Stela self-cure bulk fill composite

Operative procedures were performed under local anesthesia and rubber dam isolation. Cavities were prepared using round diamond points (for enamel) and straight fissure and round carbide burs (for cutting in dentin) in a high-speed handpiece. Remaining infected carious dentin was excavated using a hand excavator. Cavities were finished using fine grit yellow-coded tapered diamond stones. 37% phosphoric acid gel was applied for 15 seconds on enamel margins, rinsed with water for 15 seconds and cavities were air-dried with Teflon protection on dentin. Self-etching universal adhesive was actively rubbed on cavity surfaces. Light curing was performed for 20 seconds. In cavities without a liner, Stela self-cure bulk fill composite were placed in bulk (maximum 4mm thickness layer) and cured for 40 seconds, Occlusal adjustments were performed.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Faculty of Dentistry, Mansoura University, Egypt

Al Mansurah, Dakahliya, Egypt,, Egypt

Countries

Egypt

Other Identifiers

M0202025CD

Identifier Type: -

Identifier Source: org_study_id