Clinical Evaluation of Bioactive Restorative Materials

NCT07003360 | Active Not Recruiting

• 1 other identifier: M0202025CD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Class I Dental Caries

Keywords

class I dental caries; bioactive materials; biofilm inhibition; remineralizing potential

Outcome Measures

Primary Outcomes (2)

• Postoperative hypersensitivity/pulp status

  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.

  Two years after restoration

• Marginal adaptation

  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.

  Two years after restoration]

Study Arms (4)

application of beautiful blukfill II shofu composite

ACTIVE COMPARATOR

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.

Procedure: application of beautiful blukfill II shofu composite

application of Ivoclar vivadent bulkfill composite

ACTIVE COMPARATOR

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.

Procedure: application of Ivoclar vivadent bulkfill composite

application of Predicta bulk fill composite

ACTIVE COMPARATOR

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.

Procedure: application of Predicta bulk fill composite

application of Stela self-cure bulk fill composite

ACTIVE COMPARATOR

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.

Procedure: application of Stela self-cure bulk fill composite

Interventions

application of beautiful blukfill II shofu composite 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 beautiful blukfill II shofu composite

application of Ivoclar vivadent bulkfill composite 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 Ivoclar vivadent bulkfill composite

application of Predicta bulk fill composite 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 Predicta bulk fill composite

application of Stela self-cure bulk fill composite 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.

application of Stela self-cure bulk fill composite

Eligibility Criteria

• Age: 20 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• High caries risk patients with extremely poor oral hygiene
• Patients involved in orthodontic treatment or periodontal surgery,
• Patients with periodontally involved teeth (chronic

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry, Mansoura University, Egypt

Al Mansurah, Dakahliya, Egypt,, 35516, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: * The teeth will be divided randomly into four main groups according to the restorative material will be used: * Each main group (n=10) depending on the material that will be used
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2025
• First Posted: June 4, 2025
• Study Start: March 2, 2025
• Primary Completion (Estimated): November 2, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: June 4, 2025

Record last verified: 2025-02

Locations

EG (1)