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

January 26, 2021 updated by: Mohamed Sherif, Cairo University

Evaluation of Marginal Integrity Using Modified USPHS Criteria of a Bioactive Cement in Comparison to Resin Cement in Cementation of Indirect Composite Blocks: A Randomized Clinical Trial 12 Month Follow up

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • EL Manial
      • Cairo, EL Manial, Egypt, 12566
        • Cairo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Control Group Resin cement
Control group Using resin cement
Drug: Resin Cement
Resin Cement Convinonal
Active Comparator: Intervention Group Active Cement
Intervention Group Using active cement bio activa
Drug: Active bio Activa
Cement that release fluoride
Other Names:
  • Active Cement Pulpodent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Marginal Discoloration
Time Frame: 12 Months
Check Marginal Discoloration Using Modified USPH criteria
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

October 30, 2019

Study Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

September 11, 2020

First Submitted That Met QC Criteria

September 15, 2020

First Posted (Actual)

September 21, 2020

Study Record Updates

Last Update Posted (Actual)

January 28, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CEBD-CU-2019-07-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual patient Data can be shared Upon request

IPD Sharing Time Frame

1 Year

IPD Sharing Access Criteria

Mail

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Resin Cement

Clinical Trials on Resin Cement

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe