Regenerative Endodontic ProceduresNCT07427615
Regenerative Endodontics of Immature Teeth in Multiple Visits Versus Single Visit
A study testing Regenerative Endodontic Procedure and Laser-Activated Irrigation in people with Regenerative Endodontic Procedures, run by Ahmed Ibrahim Salim at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 25 years
- Conditions the study is for
- Regenerative Endodontic Procedures
- What is being tested?
- Regenerative Endodontic Procedure and Laser-Activated Irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 29 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Non-vital immature permanent maxillary anterior teeth due to trauma or caries
- Incomplete root formation with apical foramen > 1 mm
- Medically healthy patients
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Outpatient clinic, Department of Endodontics Faculty of Dentistry, Tanta University
Tanta, Gharbia Governorate
About this study
Official title: 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.
Read the 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.
- Conditions
- Regenerative Endodontic Procedures
- Being tested
- Regenerative Endodontic Procedure, Laser-Activated Irrigation
- Keywords
- Immature permanent teeth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regenerative Endodontic ProcedureProcedure or surgery
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 IrrigationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Regenerative endodontic procedures (REPs) without laser activation | Active comparator | Regenerative endodontic procedures performed in two visits using sodium hypochlorite irrigation without laser activation. Receives: 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. Receives: 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. Receives: Procedure: Regenerative Endodontic Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Mar 2023
- Primary completion29 Nov 2024
- Study completion29 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regenerative Endodontic ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Ibrahim Salim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Ibrahim Salim, Tanta University
- Investigators
- Abeer M Darrag, Study director, Professor of Endodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07427615
- Sponsor's protocol ID
- END-5-23-1
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regenerative Endodontics of Immature Teeth in Multiple Visits Versus Single Visit Using LASER Activation Irrigation Technique
- ClinicalTrials.gov ID
- NCT07427615
- Acronym / sponsor ID
- END-5-23-1
- Conditions
- Regenerative Endodontic Procedures
- Keywords
- Immature permanent teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ahmed Ibrahim SalimUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 29 Nov 2024 (actual)
- Study completion
- 29 Nov 2025 (actual)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Regenerative endodontic procedures (REPs) without laser activation | Active comparator | Procedure: Regenerative Endodontic Procedure, Procedure: Laser-Activated IrrigationRegenerative endodontic procedures performed in two visits using sodium hypochlorite irrigation without laser activation. |
| Regenerative endodontic procedures (REPs) with laser activation (two visits) | Experimental | Procedure: Regenerative Endodontic Procedure, Procedure: Laser-Activated IrrigationRegenerative endodontic procedures performed in two visits using sodium hypochlorite irrigation with 810-nm diode laser activation. |
| Regenerative endodontic procedures (REPs) with laser activation (single visit) | Experimental | Procedure: Regenerative Endodontic ProcedureRegenerative endodontic procedures completed in a single visit using sodium hypochlorite irrigation with 810-nm diode laser activation. |
Who may qualify
- Ages
- 9 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Non-vital immature permanent maxillary anterior teeth due to trauma or caries
- Incomplete root formation with apical foramen > 1 mm
- Medically healthy patients
Key exclusion criteria (1 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regenerative Endodontic ProcedureRegenerative 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 or surgery | 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 IrrigationIrrigation 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. | Procedure or surgery | Regenerative endodontic procedures (REPs) with laser activation (two visits), Regenerative endodontic procedures (REPs) without laser activation |
Primary outcome
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.
4 secondary outcomes
Change in Root Length Measured by CBCT
Time frame: Baseline, 6 months, 12 months
Change in Root Canal Width Measured by CBCT
Time frame: Baseline, 6 months, 12 months
Change in Apical Diameter Measured by CBCT
Time frame: Baseline, 6 months, 12 months
Change in Periapical Lesion Size Measured by CBCT
Time frame: Baseline, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Regenerative Endodontic Procedures
Not yet recruitingObservational study
The Effect of Using Different Scaffolds in Retreated Teeth on The Clinical and Radiological Success of Regenerative Endodontic Treatment
Endodontics, Regenerative Endodontic Procedures
Active, not recruiting
Regenerative Root Canal Treatment of Immature Teeth Using Omega-3 Fatty Acids
Immature Permanent Teeth With Open Apex, Pulp Necrosis
Enrolling by invitation
Maximum Occlusal Bite Force of Necrotic Permanent Teeth Treated by Regenerative Technique: Randomized Clinical Trial
Necrotic Pulp, Regenerative Endodontic Procedures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abeer M Darrag study director
Professor of Endodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regenerative Endodontic Procedure and Laser-Activated Irrigation in people with Regenerative Endodontic Procedures, run by Ahmed Ibrahim Salim at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Success Rate at 12 Months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.