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NCT04646538 Clinical Trial

Volume Assessment of the Periapical Healing Following Regenerative Endodontic Procedures Using Cone- Bean Computed Tomography

Necrotic Pulp Clinical Trial

Official title:
3 D Volume Assessment of the Periapical Healing Following Regenerative Endodontic Procedures Using Cone- Bean Computed Tomography

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04646538
Other study ID # 19832009
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date June 5, 2017
Est. completion date December 30, 2018

Study information
Verified date November 2020
Source Alexandria University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

3D volume assessment was done to evaluate the periapical healing following REPs in mature teeth.

Description:

REPs were done for 10 mature maxillary necrotic teeth with periapical lesions confirmed by digital periapical radiographs. Instrumentation was done using Protaper Next till size X3 (size 30). Pre-operative radiographs also included CBCT scans to measure the 3D volume and area of the periapical lesion to be used as baseline data. The postoperative radiographic examination included: a) digital periapical radiographs taken at 3,6,9, and 12 months to monitor the lesion through out the follow-up period. b)CBCT scan to measure quantitatively the volume and area of the periapical lesion after 12 months follow up

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date December 30, 2018
Est. primary completion date August 20, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - Necrotic Mature Maxillary anterior teeth with periapical lesions. Exclusion Criteria: - Patients with mobile and fractured teeth

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Regenerative Endodontics Procedures (REPs)
REPs was done for 10 mature maxillary necrotic teeth with periapical lesions. Instrumentation was done using Protaper Next system till size X3. Irrigation with 1.5 % NaOCl was done in the first visit. in the second visit, bleeding was induced in the canal by irritating the periapical area followed by the application of Biodentine as cervical plug then completion of the coronal restoration.

Locations
Country Name City State
Egypt Alexandria University Alexandria

Sponsors (1)
Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measurement the volume of periapical lesion preoperatively and comparing it with the new volume after REPs using cone-beam computed tomography. Measuring the volume in mm3 12 months
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