Clinical Evaluation of Self- Cure Bulk-Fill Resin Composite Versus Conventional Bulk-Fill Resin Composite Versus Conventional Bulk-Fill Resin Composite Clinical Evaluation of Self- Cure Bulk-Fill Resin Composite Versus Conventional Bulk-Fill Resin Composite

Not Applicable

Not yet recruiting

• Conditions: Proximal Cavities of Posterior Teeth

• Registration Number: NCT06859086
• Lead Sponsor: Cairo University

Brief Summary

the aim of this study is To evaluate and compare the clinical performance of Self- Cure Bulk fill Composite Resin Versus Conventional Bulk fill resin composite in Restoration of Proximal Lesions over a Period of 24 months Follow-up.

Detailed Description

Examination and selection of all patients will be done according to inclusion and exclusion criteria. A class II cavity will be prepared after local anesthesia has been given as required. Sectional matricing and wedging will be done.Followed by, placement of restorative material according to the randomization sequence.

For the intervention: The sectional matrix will be applied first, followed by filling of cavity with Self-Cure bulk-fill Resin Composite. (Stela Automix or Stela Capsule, SDI Ltd, Australia) For the control group: The sectional matrix will be applied first, followed by filling of the cavity with the bulk-fill resin composite material (Tetric N-Ceram Bulk Fill, Liechtenstein). Clinical evaluation will be done using USPHS criteria at 6,12,18 and 24 monthes follow up

Study Timeline

• Study First Submitted: 2025-02-23
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-02
• Last Update Submitted: 2025-03-02
• Study First Posted: 2025-03-05
• Last Update Posted: 2025-03-05
• Study Start: 2025-04
• Primary Completion: 2027-04
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Marginal adaptation	24 months	The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation, Bravo for acceptable and charlie for clinically unacceptable and in need of replacement.

Secondary Outcome Measures

Name	Time	Method
Marginal discoloration	24 months	The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation, Bravo for acceptable and charlie for clinically unacceptable and in need of replacement.
Recurrent caries	24 months	The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation and charlie for clinically unacceptable and in need of replacement.
Retention analysis	24 months	The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation and charlie for clinically unacceptable and in need of replacement.
Surface roughness	24 months	The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation, Bravo for acceptable and charlie for clinically unacceptable and in need of replacement.
Postoperative sensitivity	24 months	The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation and charlie for clinically unacceptable and in need of replacement.
Anatomic form	24 months	The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation, Bravo for acceptable and charlie for clinically unacceptable and in need of replacement.
Proximal contact	24 months	The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation, Bravo for acceptable and charlie for clinically unacceptable and in need of replacement.
Color match	24 months	The restoration will be clinically assessed using USPHS criteria. Restoration will be given Alpha for the ideal clinical situation, Bravo for acceptable and charlie for clinically unacceptable and in need of replacement.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt