An interventional study of Diode laser and Sodium Hypochlorite Solution in Irreversible Pulpitis (Toothache), sponsored by Rana Hegaz. Recruiting at 1 site in Egypt. Open to participants aged 16 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-12-17.
Sponsored by Rana Hegaz · Not applicable, Interventional, and Treatment
this clinical trial is evaluating the outcome of laser assisted pulpotomy compared to conventional pulpotomy in mature teeth with symptomatic irreversible pulpitis (SIP) assessed by CBCT followed by automated segmentation using Artificial intelligence (AI).
Sixty human permanent molar teeth having irreversible pulpitis will be selected. Teeth will be randomly divided into 3 groups according to the type of pulpotomy; Group A: Photobiomodulation (PBM) pulpotomy, Group B: photocoagulation pulpotomy and Group C: Conventional pulpotomy which will serve as control. All 3 groups will be capped with bioceramic putty material. Post operative pain will be assessed at 24, 48 and 72 hours then after one week using numerical rating scale (NRS). Clinical and radiographic assessment using periapical radiograph of the healing progress will be done simultaneously during the follow up at one, three, six and 12 months intervals. CBCT will be done immediate postoperative and at the end of the follow up period to assess the dentin bridge formation and for automated segmentation to assess the radicular pulp volume changes.
142 studies on the registry are indexed under Toothache; 28 are open to participants now.
This study's planned enrollment of 60 is below the median of 84 across 123 interventional studies indexed under Toothache.
Browse Toothache studies →This is the only study on the registry with Rana Hegaz as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
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.
Device: Diode laser
Device: Diode laser
Other: Sodium Hypochlorite Solution
a contact-type laser, it selectively and precisely affects only the tissues directly beneath it, thereby preserving the surrounding radicular tissue
A disinfecting agent used in conventional pulpotomy procedures
Assessment of healing progress
evaluating clinically the signs and symptoms of pain and it will be recorded as yes and no question. \-
Time frame: one year
Radiographic assessment of the dentin bridge formation
evaluating the dentin bridge formation using periapical radiographs and CBCT
Time frame: one year
Automated segmentation of the radicular pulp space
this will be done using CBCT imaging
Time frame: one year
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2025 (actual). Primary completion is estimated for May 2026, 6 months after the start.
Of 44 non-industry interventional studies with no phase under Toothache, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 15. This study's planned 6 months is above that.
Counting every sponsor, half of 45 studies reached it within 5 months; a quarter within 3 and three quarters within 12.
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