NCT07700394

Brief Summary

A randomized control trial which aim to compare the healing potential for the following treatment options for mature teeth with apical periodontitis: Group I: Conventional root canal treatment (CRT) Group II: Regenerative endodontic treatment (RET) using a blood clot scaffold Group III: RET using a blood clot scaffold loaded with recombinant human BMPs (rhBMPs)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
Last Updated

July 15, 2026

Status Verified

June 1, 2026

Enrollment Period

4.3 years

First QC Date

July 1, 2026

Last Update Submit

July 14, 2026

Conditions

Apical Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Healing in terms of volumetric change of lesion analyzed by CBCT

    1 year

Study Arms (3)

Conventional RCT

ACTIVE COMPARATOR
Procedure: root canal treatment and intracanal medicament

RET using a BMPs

EXPERIMENTAL
Procedure: Regeneration with BMPs

Regenerative endodontic treatment

EXPERIMENTAL
Procedure: Regeneration

Interventions

root canal treatment and intracanal medicamentPROCEDURE

conventional root canal treatment with obturation

Conventional RCT
RegenerationPROCEDURE

Regeneration using induction of bleeding

Regenerative endodontic treatment
Regeneration with BMPsPROCEDURE

RET using a blood clot scaffold loaded with recombinant human BMPs (rhBMPs)

RET using a BMPs

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients aged 18-30 years
  • Healthy patients with no systemic diseases or known allergic reactions
  • Mature permanent molars diagnosed with pulp necrosis
  • Presence of a medium sized periapical lesion confirmed clinically and radiographically (PAI=3,4,5)

You may not qualify if:

  • Patients with generalized chronic periodontitis
  • Presence of small periapical lesions (PAI=1,2)
  • Periodontal pockets \> 3 mm
  • Presence of systemic diseases or known hypersensitivity to any material used in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dentistry ain shams university

Cairo, Egypt

Location

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Regeneration

Condition Hierarchy (Ancestors)

Periapical DiseasesJaw DiseasesStomatognathic DiseasesPeriodontal DiseasesMouth DiseasesPeriodontitis

Intervention Hierarchy (Ancestors)

Biological Phenomena

Study Officials

  • Shehab El Din Mohamed Saber, PHD

    Faculty of dentistry Ain Shams University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 14, 2026

Study Start

December 1, 2021

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

July 15, 2026

Record last verified: 2026-06

Locations

EG(1)