An interventional study of regenerative endodontic procedure (REP) and 810 nm diode laser-assisted canal disinfection in Mature Teeth and Endodontic Regeneration, sponsored by Future University in Egypt. Not yet recruiting at 1 site in Egypt. Open to participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Future University in Egypt · Not applicable, Interventional, and Treatment
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.
Future University in Egypt is the lead sponsor of 105 studies on the registry; 32 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Procedure: regenerative endodontic procedure (REP)
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.
Procedure: regenerative endodontic procedure (REP) · Device: 810 nm diode laser-assisted canal disinfection
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.
Procedure: regenerative endodontic procedure (REP) · Device: 810 nm diode laser-assisted canal disinfection · Device: Photobiomodulation (810 nm diode laser)
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.
Change in periapical lesion volume (mm3) measured on CBCT
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.
Time frame: baseline and 12 month
Postoperative pain intensity (Numeric Rating Scale)
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.
Time frame: Preoperative (baseline), 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours
Postoperative analgesic intake
Whether any analgesic was taken since the previous assessment, with the number of doses and dose per intake, recorded at each telephone contact.
Time frame: 6 hours, 12 hours, 24 hours, 48 hours, and 72 hours
Resolution of clinical signs and symptoms
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.
Time frame: Preoperative (baseline), second visit, 3 months, 6 months, and 12 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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