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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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07427615
Enrollment
30
Registered
2026-02-23
Start date
2023-03-01
Completion date
2025-11-29
Last updated
2026-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Regenerative Endodontic Procedures

Keywords

Immature permanent teeth

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.

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.

Interventions

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.

PROCEDURELaser-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.

Sponsors

Ahmed Ibrahim Salim
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
9 Years to 25 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Clinical Success Rate at 12 Months12 monthsClinical 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

MeasureTime frameDescription
Change in Root Length Measured by CBCTBaseline, 6 months, 12 monthsRoot 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.
Change in Root Canal Width Measured by CBCTBaseline, 6 months, 12 monthsRoot canal width will be measured in millimeters (mm) using CBCT imaging and OnDemand 3D software.
Change in Apical Diameter Measured by CBCTBaseline, 6 months, 12 monthsPeriapical 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.
Change in Periapical Lesion Size Measured by CBCTBaseline, 6 months, 12 monthsPeriapical lesion size will be measured in millimeters (mm) using CBCT imaging and OnDemand 3D software.

Countries

Egypt

Contacts

STUDY_DIRECTORAbeer M Darrag

Professor of Endodontics

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026