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OpenTrials
Completed

NCT Number: NCT07427615

Regenerative Endodontics of Immature Teeth in Multiple Visits Versus Single Visit

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.

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Key information

Conditions

Regenerative Endodontic Procedures

Age range

9 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Tanta, Gharbia Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Clinical Success Rate at 12 Months

    Time frame: 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.

Secondary outcomes

  1. Change in Root Length Measured by CBCT

    Time frame: Baseline, 6 months, 12 months

    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.

  2. Change in Root Canal Width Measured by CBCT

    Time frame: Baseline, 6 months, 12 months

    Root canal width will be measured in millimeters (mm) using CBCT imaging and OnDemand 3D software.

  3. Change in Apical Diameter Measured by CBCT

    Time frame: Baseline, 6 months, 12 months

    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.

  4. Change in Periapical Lesion Size Measured by CBCT

    Time frame: Baseline, 6 months, 12 months

    Periapical lesion size will be measured in millimeters (mm) using CBCT imaging and OnDemand 3D software.

Sponsors and collaborators

Lead sponsor

Ahmed Ibrahim Salim

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Feb 23, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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