NCT04646538

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 30, 2020

Completed
Last Updated

November 30, 2020

Status Verified

November 1, 2020

Enrollment Period

1.2 years

First QC Date

November 18, 2020

Last Update Submit

November 25, 2020

Conditions

Necrotic PulpPeriapical; Infection

Keywords

REPsCBCTvolumeMature teeth

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

X3 group

EXPERIMENTAL
Other: Regenerative Endodontics Procedures (REPs)

Interventions

Regenerative Endodontics Procedures (REPs)OTHER

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.

X3 group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Necrotic Mature Maxillary anterior teeth with periapical lesions.

You may not qualify if:

  • Patients with mobile and fractured teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria University

Alexandria, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 34826060DERIVED

MeSH Terms

Conditions

Dental Pulp NecrosisInfections

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

November 18, 2020

First Posted

November 30, 2020

Study Start

June 5, 2017

Primary Completion

August 20, 2018

Study Completion

December 30, 2018

Last Updated

November 30, 2020

Record last verified: 2020-11

Locations

EG(1)