Regenerative Endodontics of Immature Teeth in Multiple Visits Versus Single Visit

NCT07427615 | Completed

• 1 other identifier: END-5-23-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial evaluated the clinical and radiographic outcomes of regenerative endodontic procedures performed using different irrigation activation protocols in immature permanent maxillary anterior teeth. Thirty patients were randomly assigned into three groups according to the use of laser-activated irrigation and number of visits. Clinical and cone beam computed tomographic (CBCT) outcomes were assessed over a 12-month follow-up period.

Conditions

Regenerative Endodontic Procedures

Keywords

Immature permanent teeth

Outcome Measures

Primary Outcomes (1)

• Clinical Success Rate at 12 Months

  Clinical success defined as the absence of pain, tenderness to percussion, swelling, or sinus tract, assessed through standardized clinical examination. The outcome will be reported as the number and percentage of treated teeth demonstrating clinical success.

  12 months

Secondary Outcomes (4)

• Change in Root Length Measured by CBCT

  Baseline, 6 months, 12 months

• Change in Root Canal Width Measured by CBCT

  Baseline, 6 months, 12 months

• Change in Apical Diameter Measured by CBCT

  Baseline, 6 months, 12 months

• Change in Periapical Lesion Size Measured by CBCT

  Baseline, 6 months, 12 months

Study Arms (3)

Regenerative endodontic procedures (REPs) without laser activation

ACTIVE COMPARATOR

Regenerative endodontic procedures performed in two visits using sodium hypochlorite irrigation without laser activation.

Procedure: Regenerative Endodontic Procedure; Procedure: Laser-Activated Irrigation

Regenerative endodontic procedures (REPs) with laser activation (two visits)

EXPERIMENTAL

Regenerative endodontic procedures performed in two visits using sodium hypochlorite irrigation with 810-nm diode laser activation.

Procedure: Regenerative Endodontic Procedure; Procedure: Laser-Activated Irrigation

Regenerative endodontic procedures (REPs) with laser activation (single visit)

EXPERIMENTAL

Regenerative endodontic procedures completed in a single visit using sodium hypochlorite irrigation with 810-nm diode laser activation.

Procedure: Regenerative Endodontic Procedure

Interventions

Regenerative Endodontic Procedure PROCEDURE

Regenerative endodontic procedure performed using sodium hypochlorite irrigation, intracanal double antibiotic paste, platelet-rich fibrin scaffold, and bioceramic coronal barrier according to a standardized clinical protocol.

Regenerative endodontic procedures (REPs) with laser activation (single visit); Regenerative endodontic procedures (REPs) with laser activation (two visits); Regenerative endodontic procedures (REPs) without laser activation

Laser-Activated Irrigation PROCEDURE

Irrigation activation using an 810-nm diode laser with a power of 1 W, applied for three cycles of 15 seconds with 15-second intervals, performed 1 mm short of the working length.

Regenerative endodontic procedures (REPs) with laser activation (two visits); Regenerative endodontic procedures (REPs) without laser activation

Eligibility Criteria

• Age: 9 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Non-vital immature permanent maxillary anterior teeth due to trauma or caries
• Incomplete root formation with apical foramen \> 1 mm
• Medically healthy patients

You may not qualify if:

• Allergy to medications used in the study Teeth requiring post and core restorations Periodontal pockets \> 4 mm Apical foramen \< 1 mm Periapical radiolucency \> 10 mm Internal or external root resorption History of major systemic surgeries (e.g., cardiac surgery, kidney transplantation, hemodialysis)

Sponsors & Collaborators

• Ahmed Ibrahim Salim: lead

Study Sites (1)

Outpatient clinic, Department of Endodontics Faculty of Dentistry, Tanta University

Tanta, Gharbia Governorate, Egypt

Location

Study Officials

• Abeer M Darrag

  Professor of Endodontics

  STUDY DIRECTOR

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: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Endodontics

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 23, 2026
• Study Start: March 1, 2023
• Primary Completion: November 29, 2024
• Study Completion: November 29, 2025
• Last Updated: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)