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

NCT ID: NCT04557657

Last Updated: 2021-01-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-01
• Study Completion Date: 2021-03-31

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

Conditions

Resin Cement

Study Design

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

Study Groups

Control Group Resin cement

Control group Using resin cement

Group Type: EXPERIMENTAL

Resin Cement

Intervention Type: DRUG

Resin Cement Convinonal

Intervention Group Active Cement

Intervention Group Using active cement bio activa

Group Type: ACTIVE_COMPARATOR

Active bio Activa

Intervention Type: DRUG

Cement that release fluoride

Interventions

Active bio Activa

Cement that release fluoride

Intervention Type: DRUG

Resin Cement

Resin Cement Convinonal

Intervention Type: DRUG

Other Intervention Names

Active Cement Pulpodent

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Sherif

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cairo University

Cairo, EL Manial, Egypt

Countries

Egypt

Other Identifiers

CEBD-CU-2019-07-17

Identifier Type: -

Identifier Source: org_study_id