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

NCT07609732 | Completed

• 1 other identifier: 28/2/1993
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Regenerative Endodontic Treatment; Cleaning and Shaping Only With Proper Coronal Seal; Necrotic Mature First Premolar

Keywords

Regenerative endodontic treatment; Regeneration in mature teeth; cleaning and shaping only concept

Outcome Measures

Primary Outcomes (1)

• Resolution of the clinical and radiographic sign and symptoms

  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 Outcomes (1)

• restoring of the pulp vitality which will be recorded by electric pulp tester

  3,6,12 months

Study Arms (3)

Control group

NO INTERVENTION

conventional endodontic treatment, the canals were filled by conventional gutta percha with proper coronal seal

Regeneration group

ACTIVE COMPARATOR

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

Cleaning and shaping only group

EXPERIMENTAL

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

Interventions

cell homing OTHER

it is done by bleeding induction into the canals

Regeneration group

Cleaning and shaping only PROCEDURE

proper canal disinfection and mechanical instrumentation followed by proper coronal seal

Cleaning and shaping only group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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…

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty Of Dentistry Ain Shams University

Cairo, Cairo Governorate, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Endodontist

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 27, 2026
• Study Start: August 3, 2024
• Primary Completion: April 7, 2025
• Study Completion: April 11, 2026
• Last Updated: June 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)