An interventional study of Diode laser full pulpotomy and Sodium hypochlorite pulpotomy in Irreversible Pulpitis (Toothache), sponsored by King Abdullah University Hospital. Active, not recruiting at 1 site in Jordan. Open to participants aged 10 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by King Abdullah University Hospital · Not applicable, Interventional, and Treatment
This study compares two methods used during full pulpotomy, a treatment for teeth with deep tooth decay that has exposed the dental pulp.
In the first method, the dentist removes the affected pulp tissue using a high-speed dental bur and then controls the bleeding using a sodium hypochlorite solution.
In the second method, the dentist also removes the affected pulp tissue using a high-speed dental bur, but a diode laser is used to control the bleeding. The laser may provide additional disinfection and achieve bleeding control more quickly.
After treatment, participants will be monitored to assess their level of pain relief. They will also return for follow-up visits at 6 months and 12 months, when dental X-rays will be taken to evaluate the success of the treatment.
Vital pulp therapy (VPT) is a minimally invasive treatment that aims to preserve the vitality and function of the dental pulp after exposure caused by deep caries. Compared with root canal treatment, VPT preserves the remaining healthy pulp tissue, allowing the tooth to maintain its natural defense mechanisms and reparative capacity. Full pulpotomy has become an accepted treatment option for permanent teeth with carious pulp exposure when the radicular pulp is considered healthy and capable of healing. Clinical studies have demonstrated high success rates for full pulpotomy in appropriately selected cases.
Successful pulpotomy depends on adequate removal of the inflamed coronal pulp tissue, effective control of pulpal bleeding, reduction of bacterial contamination, and placement of a suitable biocompatible pulp-capping material. Conventionally, hemostasis is achieved using sodium hypochlorite following removal of the coronal pulp tissue with a high-speed bur. Although this technique has demonstrated favorable outcomes, alternative methods that may improve hemostasis and enhance tissue healing continue to be investigated.
Diode lasers have been increasingly used in dentistry for soft tissue procedures because of their ability to provide precise tissue interaction, coagulation, and effective hemostasis. In addition to controlling bleeding, diode lasers have antimicrobial properties and may promote wound healing through biostimulatory effects that support tissue repair and reparative dentin formation. These characteristics suggest that diode laser-assisted pulpotomy may offer clinical advantages over the conventional technique.
Despite the increasing use of diode lasers in dentistry, clinical evidence regarding their use in full pulpotomy of permanent teeth with carious pulp exposure remains limited. Most published studies have evaluated diode laser pulpotomy in primary teeth or animal models, and randomized clinical trials in permanent teeth are lacking.
This randomized clinical trial is designed to compare diode laser-assisted full pulpotomy with the conventional full pulpotomy technique in permanent teeth with carious pulp exposure. In both study groups, the coronal pulp tissue will be removed using a conventional high-speed bur. In the control group, hemostasis will be achieved using sodium hypochlorite. In the experimental group, a diode laser will be used to achieve hemostasis following pulp removal. The same pulp-capping material and definitive restoration protocol will be used in both groups to ensure that the method of achieving hemostasis is the primary variable under investigation.
Participants will be evaluated for postoperative pain following treatment. Clinical and radiographic outcomes will be assessed at 6 and 12 months to determine treatment success. The study aims to determine whether diode laser-assisted full pulpotomy provides clinical and radiographic outcomes comparable to or better than those of the conventional technique.
142 studies on the registry are indexed under Toothache; 28 are open to participants now.
This study's planned enrollment of 70 is below the median of 84 across 123 interventional studies indexed under Toothache.
Browse Toothache studies →King Abdullah University Hospital is the lead sponsor of 55 studies on the registry; 22 are open to participants now.
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Non -contributory medical history (SAI, II).
Exclusion Criteria:
Medically compromised patient.
Diode laser used after the full pulpotomy to achieve hemostasis following cutting of the pulp tissue.
Procedure: Diode laser full pulpotomy
The use of sodium hypochlorite to achieve hemostasis after cutting the pulp tissue to th level of root canal orifices
Procedure: Sodium hypochlorite pulpotomy
The use of diode laser to achieve hemostasis after cutting the coronal part of the pulp tissue which is present in the tooth crown, down to the level of the canal orifices.
The use of Sodium hypochlorite to achieve hemostasis after full pulpotomy
Postoperative pain after pulpotomy
Postoperative pain will be assessed using an 11-point Numeric Rating Scale (NRS), where 0 indicates "no pain" and 10 indicates "the worst pain imaginable." Participants will record their pain intensity at the prespecified postoperative time points.
Time frame: One week after treatment
Success of pulpotomy
Clinical and radiographic success will be evaluated at the follow-up visits. Clinical success is defined as the absence of spontaneous pain, tenderness to percussion, swelling, sinus tract, pathological mobility, or other signs and symptoms indicating pulpal or periapical disease. Radiographic success is defined as the absence of periapical radiolucency, furcation involvement, external or internal root resorption, widening of the periodontal ligament space, or other radiographic evidence of treatment failure.
Time frame: Six and 12 months after treatment
Tooth survival
Tooth survival will be defined as the percentage of treated teeth remaining in the mouth and functioning without extraction during the follow-up period, regardless of the radiographic findings as far as the tooth is asymptomatic.
Time frame: 12 months after treatment
Plan to share: Undecided — Individual participant data will not be shared because of institutional data-sharing policies and the need to protect participant confidentiality.
Started Oct 2025 (actual). Primary completion is estimated for Jun 2027, 20 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 20 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.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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King Abdullah University Hospital