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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04274920
Other study ID # REC16-071
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 1, 2017
Est. completion date July 1, 2018

Study information

Verified date February 2020
Source Al-Azhar University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date July 1, 2018
Est. primary completion date May 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Intervention

Other:
Bioactive Glass
Bioactive glass was incorporated in resin composite and its adhesive
Light cured calcium hydroxide
Light cured calcium hydroxide

Locations

Country Name City State
Egypt AlAzhar University, Faculty of Dentistry for Girls Cairo

Sponsors (1)

Lead Sponsor Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of dentine thickness Thickness in millimeters using CBCT baseline, one month, 3 months and 6 months
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