Regenerative Endodontics of Immature Teeth in Multiple Visits Versus Single Visit

Regenerative Endodontics of Immature Teeth in Multiple Visits Versus Single Visit Using LASER Activation Irrigation Technique

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.

Study Overview

• Status: Completed
• Conditions: Regenerative Endodontic Procedures
• Intervention / Treatment: Procedure: Regenerative Endodontic Procedure; Procedure: Laser-Activated Irrigation

Detailed Description

Thirty patients aged 9-25 years with non-vital immature permanent maxillary anterior teeth were included. Patients were randomly allocated into three equal groups based on the irrigation activation technique and number of visits. Regenerative endodontic procedures were performed following standardized protocols. Clinical evaluations were conducted at multiple follow-up intervals, while radiographic assessments using CBCT were performed at baseline, 6, and 12 months to evaluate root development and periapical healing.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Gharbia Governorate
    • Tanta, Gharbia Governorate, Egypt
      • Outpatient clinic, Department of Endodontics Faculty of Dentistry, Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Regenerative endodontic procedures (REPs) without laser activation; Regenerative endodontic procedures performed in two visits using sodium hypochlorite irrigation without laser activation.	Procedure: Regenerative Endodontic 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.; Procedure: Laser-Activated Irrigation; 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.
Experimental: Regenerative endodontic procedures (REPs) with laser activation (two visits); Regenerative endodontic procedures performed in two visits using sodium hypochlorite irrigation with 810-nm diode laser activation.	Procedure: Regenerative Endodontic 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.; Procedure: Laser-Activated Irrigation; 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.
Experimental: Regenerative endodontic procedures (REPs) with laser activation (single visit); Regenerative endodontic procedures completed in a single visit using sodium hypochlorite irrigation with 810-nm diode laser activation.	Procedure: Regenerative Endodontic 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Root Length Measured by CBCT	Root length will be measured in millimeters (mm) using cone beam computed tomography (CBCT) imaging with a slice thickness of 0.5 mm, voxel size of 0.5 mm, and exposure parameters of 90 kV and 11 mA. Measurements will be obtained using OnDemand 3D software. The change in root length from baseline to 6 and 12 months will be calculated.	Baseline, 6 months, 12 months
Change in Root Canal Width Measured by CBCT	Root canal width will be measured in millimeters (mm) using CBCT imaging and OnDemand 3D software.	Baseline, 6 months, 12 months
Change in Apical Diameter Measured by CBCT	Periapical lesion size will be measured in millimeters (mm) using CBCT imaging and OnDemand 3D software. The reduction in lesion size from baseline to 6 and 12 months will be calculated.	Baseline, 6 months, 12 months
Change in Periapical Lesion Size Measured by CBCT	Periapical lesion size will be measured in millimeters (mm) using CBCT imaging and OnDemand 3D software.	Baseline, 6 months, 12 months

Collaborators and Investigators

• Sponsor: Ahmed Ibrahim Salim
• Investigators: Study Director: Abeer M Darrag, Professor of Endodontics

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Actual): November 29, 2024
• Study Completion (Actual): November 29, 2025

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 20, 2026
• First Posted (Actual): February 23, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Immature permanent teeth
• Other Study ID Numbers: END-5-23-1

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