Dentin Bridge Formation After Indirect Pulp Capping With Bioactive Glass Incorporated in Resin Composite and Its Adhesive in Comparison With Light Cured Calcium Hydroxide

Sponsor

Al-Azhar University (Other)

Overall Status

Completed

CT.gov ID

NCT04274920

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the effect of application of bioactive glass in different protocols on the formation of dentin bridge after indirect pulp capping using resin composite with its adhesive both are containing bioactive glass.

Condition or Disease	Intervention/Treatment	Phase
Pulp Disease, Dental Dental Caries	Other: Bioactive Glass Other: Light cured calcium hydroxide	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Clinical Response of Human Pulps Capped With Bioactive Glass Incorporated in Resin Composite and Adhesive

Actual Study Start Date :

Mar 1, 2017

Actual Primary Completion Date :

May 1, 2018

Actual Study Completion Date :

Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bioactive Glass 18 teeth were capped indirectly with dental adhesive containing bioactive glass applied according to the manufacturer's instructions and cured for 20 seconds and then resin composite restoration containing bioactive glass applied by golden plated composite applicator in increments 2 mm each and cured for 40 seconds for each increment.	Other: Bioactive Glass Bioactive glass was incorporated in resin composite and its adhesive
Active Comparator: Light cured calcium hydroxide 18 teeth were capped indirectly with light cured calcium hydroxide (control group) applied according to the manufacturer's instructions by calcium hydroxide applicator and light cured for 20 seconds then resin composite restoration was applied by golden plated composite applicator in increments 2 mm each and cured for 40 seconds for each increment.	Other: Light cured calcium hydroxide Light cured calcium hydroxide

Arm

Intervention/Treatment

Experimental: Bioactive Glass

18 teeth were capped indirectly with dental adhesive containing bioactive glass applied according to the manufacturer's instructions and cured for 20 seconds and then resin composite restoration containing bioactive glass applied by golden plated composite applicator in increments 2 mm each and cured for 40 seconds for each increment.

Other: Bioactive Glass

Bioactive glass was incorporated in resin composite and its adhesive

Active Comparator: Light cured calcium hydroxide

18 teeth were capped indirectly with light cured calcium hydroxide (control group) applied according to the manufacturer's instructions by calcium hydroxide applicator and light cured for 20 seconds then resin composite restoration was applied by golden plated composite applicator in increments 2 mm each and cured for 40 seconds for each increment.

Other: Light cured calcium hydroxide

Light cured calcium hydroxide

Outcome Measures

Primary Outcome Measures

Change of dentine thickness [baseline, one month, 3 months and 6 months]
Thickness in millimeters using CBCT

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Active carious lesion in deep dentin of molars.
Absence of cavitated lesions at the buccal or lingual surfaces as determined by clinical and radiographic examination.
Absence of clinical diagnosis of pulp exposure, fistula, swelling of periodontal tissues, and abnormal tooth mobility;
Absence of clinical symptoms of irreversible pulpitis, such as spontaneous pain or sensitivity to pressure;
The extension of the carious lesion should be such that complete caries removal would risk pulp exposure, as determined by clinical and radiographic assessment;
Absence of radiolucencies at the interradicular or periapical regions, or thickening of the periodontal spaces, that would indicate the presence of irreversible pulp pathologies or necrosis;
Absence of internal or external root resorption.
Co-operative patients approving the trial.

Exclusion Criteria:

Patients with systemic medical conditions
pregnant females
Teeth with spontaneous pain or sensitivity to percussion.
Teeth with periodontal lesions, internal or external root resorption, mobility of tooth, sinus opening, or abscessed tooth.
Radiographic examination revealed, interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AlAzhar University, Faculty of Dentistry for Girls	Cairo		Egypt

Sponsors and Collaborators

Al-Azhar University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Heba Arafa Abd El wahab Zahran, Principal Investigator, Al-Azhar University

ClinicalTrials.gov Identifier:

NCT04274920

Other Study ID Numbers:

REC16-071

First Posted:

Feb 18, 2020

Last Update Posted:

Feb 18, 2020

Last Verified:

Feb 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dental Caries

Dental Pulp Diseases

Stomatognathic Diseases

Calcium

Study Results

No Results Posted as of Feb 18, 2020