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

Primary Purpose

Necrotic Pulp, Periapical; Infection

Status

Completed

Phase

Early Phase 1

Locations

Egypt

Study Type

Interventional

Intervention

Regenerative Endodontics Procedures (REPs)

About this trial

This is an interventional treatment trial for Necrotic Pulp focused on measuring REPs, CBCT, volume, Mature teeth

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Necrotic Mature Maxillary anterior teeth with periapical lesions.

Exclusion Criteria:

Patients with mobile and fractured teeth

Sites / Locations

Alexandria University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

X3 group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT04646538

First Posted

November 18, 2020

Last Updated

November 25, 2020

Sponsor

Alexandria University

1. Study Identification

Unique Protocol Identification Number

NCT04646538

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

June 5, 2017 (Actual)

Primary Completion Date

August 20, 2018 (Actual)

Study Completion Date

December 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Necrotic Pulp, Periapical; Infection

Keywords

REPs, CBCT, volume, Mature teeth

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

X3 group

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Regenerative Endodontics Procedures (REPs)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Measurement the volume of periapical lesion preoperatively and comparing it with the new volume after REPs using cone-beam computed tomography.

Description

Measuring the volume in mm3

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Necrotic Mature Maxillary anterior teeth with periapical lesions. Exclusion Criteria: Patients with mobile and fractured teeth

Facility Information:

Facility Name

Alexandria University

City

Alexandria

Country

Egypt

12. IPD Sharing Statement

Citations:

PubMed Identifier

34826060

Citation

Kateb NME, Fata MM. Influence of periapical lesion size on healing outcome following regenerative endodontic procedures: a clinical investigation. Oral Radiol. 2022 Oct;38(4):480-489. doi: 10.1007/s11282-021-00578-8. Epub 2021 Nov 26.

Results Reference

derived

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

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