Outcomes of Conventional Root Canal Treatment Compared to Regenerative Endodontics, and Cleaning and Shaping Only in Mature Upper First Premolars

June 1, 2026 updated by: Maram Reda Afifi, Ain Shams University

The Effect of Regenerative Endodontic Procedures and Only Cleaning and Shaping on The Outcome of Adult Mature Permanent Necrotic Teeth: A Randomized Clinical Trial

It was to compare clinically between the success of the primary endodontic treatment, regeneration, and only cleaning and shaping in necrotic mature first premolars with apical periodontitis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

a- Fifty four patients were enrolled and screened for eligibility b- Participants were randomly assigned to three groups (n=18 per group) i- Group [CRCT]: Conventional root canal treatment (n=18) ii- Group [REP] : Regenerative endodontic treatment (REP) (n=18), cell homing technique was used , and MTA was placed 3mm into the canals , the access was sealed by light cured glass ionomer then composite iii- Group [C.S]: Only cleaning and shaping (n=18) the same steps of REP but without bleeding induction and MTA was placed 3mm into the canals , the access was sealed by light cured glass ionomer then composite

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt
        • Faculty of dentistry Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age: 20-50 years
  • Medically free
  • The patient should have the upper first premolar that needs endodontic treatment with apical periodontitis
  • Necrotic teeth
  • Participants were willing to commit to the entire period of the trial and agreed to sign the written consent after a full explanation of the study.

Exclusion Criteria:

  • Symptomatic irreversible pulpitis
  • If the premolar is non restorable
  • If the premolar will need a post and core
  • Vertical root fracture
  • Open apex
  • Presence of any systemic disease or allergic reactions.
  • Vulnerable group; prisoners, pregnant females, mentally ill, etc…

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
conventional endodontic treatment, the canals were filled by conventional gutta percha with proper coronal seal
Active Comparator: Regeneration group
Cell homing via bleeding induction was done, MTA was applied into the canals at a depth of 3mm, and the access was sealed by light-cured glass ionomer, then composite restorations were placed
Other: cell homing
it is done by bleeding induction into the canals
Experimental: Cleaning and shaping only group
Aseptic techniques were used while using the irrigation activation technique to enhance the irrigation effects, after then MTA was applied into the canals at a depth of 3mm, and the access was sealed by light-cured glass ionomer then composite restorations were placed to ensure proper coronal seal
Procedure: Cleaning and shaping only
proper canal disinfection and mechanical instrumentation followed by proper coronal seal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution of the clinical and radiographic sign and symptoms
Time Frame: follow ups 3, 6 12 months

Clinically, no pain upon percussion or palpation, and no sinus tracts. Signs of radiographic bone healing it is going to be recorded as a yes/ no answer. No sign and symptoms= no pain upon percussion, palpation, and no sinus tract was observed Yes, there are signs and symptoms= that one or more of these criteria will be present [ pain upon percussion, presence of a bulge upon palpation, sinus tract exists] Radiographic healing will be assessed by 2 ways.

  1. Qualitative test by using the Periapical Index Score; score 1 indicates bone healing, and score 5 indicates Severe apical periodontitis, with exacerbating features
  2. Quantitative assessment measured the percent of lesion reduction using ImageJ software to measure the area of the lesion preoperatively and at follow-ups. This rule will be used: [preoperative area - postoperative area] / preoperative area = ... X100= ..%
follow ups 3, 6 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
restoring of the pulp vitality which will be recorded by electric pulp tester
Time Frame: 3,6,12 months
The reading at each follow-up will be a yes/ no answer Yes, there is sensation if the patient feels tingling while using the electric pulp tester No, no sensation if the patient didn't feel the tingling
3,6,12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2024

Primary Completion (Actual)

April 7, 2025

Study Completion (Actual)

April 11, 2026

Study Registration Dates

First Submitted

May 13, 2026

First Submitted That Met QC Criteria

May 19, 2026

First Posted (Actual)

May 27, 2026

Study Record Updates

Last Update Posted (Actual)

June 2, 2026

Last Update Submitted That Met QC Criteria

June 1, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 28/2/1993

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Regenerative Endodontic Treatment

Clinical Trials on cell homing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cote d'Ivoire

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe