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

NCT07761962 | Active Not Recruiting

• 1 other identifier: 510/2025
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Irreversible Pulpitis (Toothache)

Keywords

Carious pulp exposure; Laser; Pulpotomy

Outcome Measures

Primary Outcomes (1)

• 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.

  One week after treatment

Secondary Outcomes (1)

• Success of pulpotomy

  Six and 12 months after treatment

Other Outcomes (1)

• Tooth survival

  12 months after treatment

Study Arms (2)

Full pulpotomy using diode laser for hemostasis

EXPERIMENTAL

Diode laser used after the full pulpotomy to achieve hemostasis following cutting of the pulp tissue.

Procedure: Diode laser full pulpotomy

Full pulpotomy using sodium hypochlorite for hemostasis

ACTIVE COMPARATOR

The use of sodium hypochlorite to achieve hemostasis after cutting the pulp tissue to th level of root canal orifices

Procedure: Sodium hypochlorite pulpotomy

Interventions

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.

Full pulpotomy using diode laser for hemostasis

Sodium hypochlorite pulpotomy PROCEDURE

The use of Sodium hypochlorite to achieve hemostasis after full pulpotomy

Full pulpotomy using sodium hypochlorite for hemostasis

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdullah University Hospital: lead

Study Sites (1)

Jordan university of science and Technology

Irbid, 3030, Jordan

Location

Related Links

• Publication on the protocol of pulpotomy published previously by the principal investigator
• A review on the treatment modality and biological bases published by the principal investigator

MeSH Terms

Conditions

Toothache

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nessrin Taha, PhD

  Jordan University of Science and Technology

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professsor

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel treatment groups. The experimental group will undergo full pulpotomy with diode laser-assisted hemostasis, while the control group will undergo conventional full pulpotomy with sodium hypochlorite for hemostasis. Participants will receive only the assigned intervention and will be followed for postoperative pain and clinical and radiographic outcomes at 6 and 12 months.

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 13, 2026
• Study Start: October 23, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2030
• Last Updated: August 13, 2026

Record last verified: 2026-08

Locations

JO (1)