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

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries; Pulp Disease, Dental
• Intervention / Treatment: Other: Bioactive Glass; Other: Light cured calcium hydroxide

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • AlAzhar University, Faculty of Dentistry for Girls

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of dentine thickness	Thickness in millimeters using CBCT	baseline, one month, 3 months and 6 months

Collaborators and Investigators

• Sponsor: Al-Azhar University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2017
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: February 10, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (Actual): February 18, 2020

Study Record Updates

• Last Update Posted (Actual): February 18, 2020
• Last Update Submitted That Met QC Criteria: February 17, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Tooth Demineralization; Tooth Diseases; Dental Caries; Dental Pulp Diseases; Stomatognathic Diseases; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: REC16-071

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No