Evaluation of Marginal Integrity Using Bioactive Cement Incementation of Indirect Composite Blocks

Phase 1

• Conditions: Resin Cement
• Interventions: Drug: Resin Cement; Drug: Active bio Activa

• Registration Number: NCT04557657
• Lead Sponsor: Cairo University

Brief Summary

The aim of this study is to evaluate of marginal integrity of indirect composite restoration after cementation by a bioactive cement in comparison to dual cure resin cement using Modified USPHS criteria

Detailed Description

The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University, The operator in charge will be: Mohamed Sherif . The researcher will bear ultimate responsibility for all activities associated with the conduct of a research project including recruitment of patients, explaining and performing the procedures to them,A total of 36 volunteer patients with Patients with badly broken vital teeth with minimum of two remaining walls. Patients will be randomly divided into two groups according to type of cement (S) where in group S1, Restoration will be cemented with resin cement ; while group S2,Restoration will be cemented with active cement. Each restoration will be assessed after three, six months and one year using modified USPH Criteria Marginal Discoloration, Recurrent Caries and Marginal Chipping with scale of Alpha and non alpha

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2019-10-30
• Study First Submitted: 2020-09-11
• Study First Submitted QC: 2020-09-15
• Study First Posted: 2020-09-21
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28
• Study Completion: 2021-03

Recruitment & Eligibility

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

Inclusion Criteria

• Patients with badly broken vital teeth with minimum of two remaining walls
• Adult Males or female 16- 65 years old
• Good oral hygiene measures with a good gingival condition
• Cooperative patients approving to participate in the study
• Free of any medical condition that interfere with procedures

Exclusion Criteria

• Patients with a compromised medical history.
• Severe or active periodontal disease
• Endodontically treated teeth
• Severe medical complications Lack of compliance

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group Resin cement	Resin Cement	Control group Using resin cement
Intervention Group Active Cement	Active bio Activa	Intervention Group Using active cement bio activa

Primary Outcome Measures

Name	Time	Method
Marginal Discoloration	12 Months	Check Marginal Discoloration Using Modified USPH criteria

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, EL Manial, Egypt