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

Resin Cement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04557657
• Other study ID #: CEBD-CU-2019-07-17
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: September 1, 2019
• Est. completion date: March 2021

Study information

• Verified date: January 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: March 2021
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Resin Cement

Intervention

Drug:
• Active bio Activa
Cement that release fluoride
• Resin Cement
Resin Cement Convinonal

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo	EL Manial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Marginal Discoloration	Check Marginal Discoloration Using Modified USPH criteria	12 Months