Different Treatment Options For Mature Teeth With Apical... | NCT07700394

Studies
Different Treatment Options For Mature Teeth With Apical Periodontitis

NCT07700394

Sponsor

Sara Tariq Elemam

Status

Completed

Last Update Posted

Jul 15, 2026Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Apical Periodontitis

Interventions

root canal treatment and intracanal medicament
Regeneration
Regeneration with BMPs

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2021Actual

Primary Completion Date

Apr 1, 2026Actual

Completion Date

Apr 1, 2026Actual

First Submitted Date

Jul 1, 2026

First Submission Date that Met QC Criteria

Jul 11, 2026

First Posted Date

Jul 14, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 14, 2026

Last Update Posted Date

Jul 15, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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)

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
root canal treatment and intracanal medicament	Procedure	conventional root canal treatment with obturation	Conventional RCT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Healing in terms of volumetric change of lesion analyzed by CBCT		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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)

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Shehab El Din Mohamed Saber, PHD	Faculty of dentistry Ain Shams University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of dentistry ain shams university		Cairo			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010485	Periapical Periodontitis

Ancestor Terms

ID	Term
D010483	Periapical Diseases
D007571	Jaw Diseases
D009057	Stomatognathic Diseases
D010510	Periodontal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided