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NCT Number: NCT07761962

Laser Assisted Pulpotomy Versus MTA Pulpotomy in Permanent Teeth With Irreversible Pulpitis

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

10 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan university of science and Technology

Irbid, 3030, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Non -contributory medical history (SAI, II).
  • Premolar or Molar permanent tooth
  • Age range 10-60 years
  • Deep caries extending>= 2/3 of dentin or exposing the pulp on the radiograph
  • The tooth should give positive response to cold sensibility testing
  • Clinical diagnosis of irreversible pulpitis based on the symptoms and results of cold testing.
  • The tooth is restorable, probing pocket depth and mobility are within normal limits
  • No signs of pulpal necrosis including sinus tract or swelling

Exclusion criteria

  • Medically compromised patient.
  • Non-restorable tooth.
  • Signs of pulpal necrosis including sinus tract or swelling.
  • No enough bleeding after the pulpotomy procedure.
  • Inability to achieve hemostasis within 10 min after the pulpotomy.

Treatment and study plan

Diode laser full pulpotomy

Procedure

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.

Sodium hypochlorite pulpotomy

Procedure

The use of Sodium hypochlorite to achieve hemostasis after full pulpotomy

Primary outcomes

  1. Postoperative pain after pulpotomy

    Time frame: One week after treatment

    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.

Secondary outcomes

  1. Success of pulpotomy

    Time frame: Six and 12 months after treatment

    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.

Other outcomes

  1. Tooth survival

    Time frame: 12 months after treatment

    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.

Sponsors and collaborators

Lead sponsor

King Abdullah University Hospital

Other

Registry information

Official study title

Comparative Evaluation of Diode Laser-Assisted Pulpotomy Versus MTA Pulpotomy in Permanent Teeth With Irreversible Pulpitis: A Randomized Clinical Trial

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Aug 13, 2026
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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