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Clinical Trials/NCT04274920
NCT04274920CompletedNot Applicable

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

Al-Azhar University1 site in 1 country36 target enrollmentStarted: March 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
36
Locations
1
Primary Endpoint
Change of dentine thickness

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
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.

Arms & Interventions

Bioactive Glass

Experimental

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.

Intervention: Bioactive Glass (Other)

Light cured calcium hydroxide

Active Comparator

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.

Intervention: Light cured calcium hydroxide (Other)

Outcomes

Primary Outcomes

Change of dentine thickness

Time Frame: baseline, one month, 3 months and 6 months

Thickness in millimeters using CBCT

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Heba Arafa Abd El wahab Zahran

Principal Investigator

Al-Azhar University

Study Sites (1)

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