Laser-Assisted Disinfection With and Without Photobiomodulation in Regenerative Endodontic Procedures for Necrotic Mature Teeth (LASER)
Radiographic and Clinical Evaluation of Regenerative Endodontic Procedures in Necrotic Mature Teeth With Apical Periodontitis Using Laser-Assisted Disinfection With and Without Adjunctive Photobiomodulation: A Three-Arm Randomized Clinical Trial
This study will compare three ways of treating adult teeth with a dead nerve (pulp) and an infection at the root tip. All three groups receive a regenerative endodontic procedure, which aims to help healthy tissue grow back inside the tooth. The groups differ in how the root canal is cleaned: (1) standard cleaning without a laser, (2) standard cleaning plus a diode laser to help disinfect the canal, or (3) standard cleaning plus the diode laser plus a single session of low-level light therapy (photobiomodulation) applied over the gum to support healing. Eighty-one patients aged 20 to 40 will be randomly placed into one of the three groups. Healing of the infection at the root tip will be measured with a 3D dental scan (CBCT) before treatment and 12 months later. Pain after treatment, painkiller use, and clinical signs such as swelling, tenderness, and gum pimples (sinus tract) will also be recorded. The study aims to find out whether adding laser treatment, with or without light therapy, improves healing.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: mohamed khalid, BDSc 2021
- Phone Number: 0201100369000
- Email: mo.khalid.at@gmail.com
Study Locations
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Cairo Governorate
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Cairo, Cairo Governorate, Egypt
- Future University in Egypt
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Contact:
- mohamed khalid
- Phone Number: 02011003669000
- Email: m7mdd5alidd@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- Good general health (ASA I or II)
- Aged 20 to 40 years
- Both sexes (male and female)
- Single-rooted mature permanent tooth
- Negative response to pulp sensibility testing (cold test)
- Periapical radiolucency ranging from widening of the lamina dura/periodontal ligament space up to a periapical lesion less than 5 mm in diameter on CBCT
- Restorable tooth with adequate remaining coronal structure and periodontal support
- Patient agrees to participate and is able to sign informed consent
Exclusion Criteria:
- Analgesic or antibiotic intake within 12 hours before the procedure
- Immature teeth
- Multi-rooted teeth
- Periapical lesion 5 mm or more in diameter
- Unrestorable teeth
- Teeth with vertical root fracture, extensive internal or external resorption, grade 2 or 3 mobility, or non-restorable coronal destruction
- Previous root canal treatment
- Systemic conditions or medications affecting healing (for example uncontrolled diabetes, immunosuppression, bisphosphonate therapy)
- Pregnant or lactating patients
- Unable to understand the procedure, provide valid consent, or comply with follow-up
- Known allergy to the irrigants or medicaments used in the protocol
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: REP's with no laser disinfection (control)
Regenerative endodontic procedure (REP) with conventional chemomechanical preparation only (2.5% sodium hypochlorite, passive ultrasonic activation, 17% EDTA, and sterile saline), followed by a calcium hydroxide intracanal dressing for 2 weeks. At the second visit: EDTA irrigation, induced apical bleeding to form a blood clot, collagen matrix, bioceramic putty barrier, and coronal seal. No laser is used. |
Two-visit regenerative endodontic procedure for necrotic mature teeth single root and single canal. Visit 1: access, working length determination, crown-down chemomechanical preparation with 2.5% sodium hypochlorite, passive ultrasonic activation, 17% EDTA, final saline rinse, and calcium hydroxide dressing for 2 weeks. Visit 2: 17% EDTA irrigation, induction of apical bleeding to form a blood clot, collagen matrix, bioceramic putty barrier, and coronal seal with glass ionomer. Performed identically in all three groups. |
|
Experimental: REP's with laser-assisted disinfection, using adjunctive 810 nm diode laser irradiation.
Same REP protocol as the control group, with the addition of 810 nm diode laser disinfection at the first visit after the final saline rinse and before the calcium hydroxide dressing. Continuous wave mode, 1.5 W, 4 cycles of 5 seconds with 20-second intervals, using a 200 micrometer fiber placed 1 mm short of the working length and moved in a slow helical motion from apical to coronal. The canal is irrigated with 5 mL saline after each cycle. The second visit is identical to the control group. |
Two-visit regenerative endodontic procedure for necrotic mature teeth single root and single canal. Visit 1: access, working length determination, crown-down chemomechanical preparation with 2.5% sodium hypochlorite, passive ultrasonic activation, 17% EDTA, final saline rinse, and calcium hydroxide dressing for 2 weeks. Visit 2: 17% EDTA irrigation, induction of apical bleeding to form a blood clot, collagen matrix, bioceramic putty barrier, and coronal seal with glass ionomer. Performed identically in all three groups. Adjunctive canal disinfection at the first visit using an 810 nm diode laser (Elexxion, Germany), continuous wave, 1.5 W, 4 cycles of 5 seconds with 20-second intervals. A 200 micrometer fiber is placed 1 mm short of the working length and moved in a slow helical motion from apical to coronal at about 2 mm per second without touching the canal walls. The canal is irrigated with 5 mL sterile saline after each cycle. |
|
Experimental: REP's with Laser-assisted disinfection and adjunctive photobiomodulation,
Same protocol as the laser-assisted disinfection group, plus a single session of transmucosal photobiomodulation (PBM) delivered at the second visit immediately after placement of the blood scaffold and coronal restoration. 810 nm diode laser, continuous wave, 200 mW, 8 mm tip in contact with the mucosa, applied at four sites per tooth (periapical and cervical regions on the buccal and lingual/palatal sides), 15 seconds and 3 J per site, for a total of 12 J per tooth. |
Two-visit regenerative endodontic procedure for necrotic mature teeth single root and single canal. Visit 1: access, working length determination, crown-down chemomechanical preparation with 2.5% sodium hypochlorite, passive ultrasonic activation, 17% EDTA, final saline rinse, and calcium hydroxide dressing for 2 weeks. Visit 2: 17% EDTA irrigation, induction of apical bleeding to form a blood clot, collagen matrix, bioceramic putty barrier, and coronal seal with glass ionomer. Performed identically in all three groups. Adjunctive canal disinfection at the first visit using an 810 nm diode laser (Elexxion, Germany), continuous wave, 1.5 W, 4 cycles of 5 seconds with 20-second intervals. A 200 micrometer fiber is placed 1 mm short of the working length and moved in a slow helical motion from apical to coronal at about 2 mm per second without touching the canal walls. The canal is irrigated with 5 mL sterile saline after each cycle. Single session of transmucosal photobiomodulation at the second visit, immediately after placement of the blood scaffold and coronal restoration. 810 nm diode laser, continuous wave, 200 mW, 8 mm tip in contact with the mucosa. Four sites per tooth (periapical and cervical regions on the buccal and lingual/palatal sides), 15 seconds and 3 J per site, for a total of 12 J per tooth. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in periapical lesion volume (mm3) measured on CBCT
Time Frame: baseline and 12 month
|
Periapical lesion volume in cubic millimeters measured on cone-beam computed tomography (CBCT) scans (field of view 50 x 50 mm, isometric voxel size 0.125 mm) by a blinded outcome assessor. Change from baseline to 12 months is compared among the three groups. |
baseline and 12 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative pain intensity (Numeric Rating Scale)
Time Frame: Preoperative (baseline), 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours
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Patient-reported pain on the Numeric Rating Scale from 0 (no pain) to 10 (worst pain imaginable), collected by telephone by a blinded study coordinator. |
Preoperative (baseline), 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours
|
|
Postoperative analgesic intake
Time Frame: 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours
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Whether any analgesic was taken since the previous assessment, with the number of doses and dose per intake, recorded at each telephone contact. |
6 hours, 12 hours, 24 hours, 48 hours, and 72 hours
|
|
Resolution of clinical signs and symptoms
Time Frame: Preoperative (baseline), second visit, 3 months, 6 months, and 12 months
|
Presence or absence of tenderness to percussion, tenderness to palpation, swelling, and sinus tract, and need for additional intervention, assessed by clinical examination by a blinded examiner. |
Preoperative (baseline), second visit, 3 months, 6 months, and 12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FUE-ENDO-REP-LASER-2026
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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