Clinical and Radiographic Assessment of Photobiomodulated MTA Pulpotomy in Immature First Permanent Molars with Irreversible Pulpitis

NCT06730360 | Recruiting

• 1 other identifier: A0109024PP
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effectiveness of photobiomodulation (PBM) in conjunction with mineral trioxide aggregate (MTA) pulpotomy for treating irreversible pulpitis in immature first permanent molars. PBM, also known as low-level laser therapy (LLLT), is used to enhance healing, reduce inflammation, and manage pain in young teeth. The randomized clinical trial involves 72 children aged 6-9 years, divided into two groups: one receiving MTA pulpotomy alone and the other receiving MTA pulpotomy with PBM. Clinical and radiographic outcomes will be assessed at intervals over 15 months. This research aims to determine the combined therapy's efficacy in improving pulp healing and reducing post-operative discomfort compared to MTA alone.

Conditions

Dental Caries; Irreversible Pulpitis

Keywords

Irreversible pulpitis; Immature permanent molars; Vital pulp therapy (VPT); Mineral trioxide aggregate (MTA); Photobiomodulation (PBM)

Outcome Measures

Primary Outcomes (1)

• Clinical Success of Pulpotomy Treatment

  Evaluation of clinical signs and symptoms (absence of pain, tenderness to percussion, sinus tract, or swelling). Treatment is considered successful if these are absent at all follow-up visits.

  15 months post-treatment (assessed at 3, 6, 12, and 15 months).

Secondary Outcomes (2)

• Radiographic Healing

  15 months post-treatment (assessed at 6, 12, and 15 months).

• Root Development Progression

  15 months post-treatment (assessed at 6, 12, and 15 months)

Other Outcomes (1)

• Postoperative Pain Intensity

  2 days post-treatment.

Study Arms (2)

MTA Pulpotomy without Photobiomodulation

ACTIVE COMPARATOR

Participants will receive MTA (Mineral Trioxide Aggregate) pulpotomy as a standard treatment without the application of photobiomodulation (low-level laser therapy).

Procedure: MTA Pulpotomy without photobiomodulation

MTA Pulpotomy with Photobiomodulation

EXPERIMENTAL

Participants will receive MTA (Mineral Trioxide Aggregate) pulpotomy treatment enhanced with photobiomodulation (low-level laser therapy). The laser will be applied to pulp stumps before the placement of MTA to promote healing and reduce inflammation. These entries should resolve the error and align with your protocol.

Procedure: MTA Pulpotomy with Photobiomodulation (LLLT)

Interventions

MTA Pulpotomy without photobiomodulation PROCEDURE

This intervention involves the application of Mineral Trioxide Aggregate (MTA) to the pulp chamber after the removal of the coronal pulp tissue in first permanent molars with irreversible pulpitis. The procedure is performed without the use of photobiomodulation (low-level laser therapy). The MTA is placed as a seal to preserve the vitality of the remaining radicular pulp.

MTA Pulpotomy without Photobiomodulation

MTA Pulpotomy with Photobiomodulation (LLLT) PROCEDURE

This intervention combines MTA pulpotomy with photobiomodulation (low-level laser therapy). After performing the MTA pulpotomy, low-level laser therapy is applied to the pulp stumps to reduce inflammation, promote healing, and modulate pain. The laser therapy uses specific wavelengths of light to stimulate cellular activity and enhance the regeneration of pulp tissue.

MTA Pulpotomy with Photobiomodulation

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6 to 9 years.
• Non-contributory medical history (healthy otherwise).
• Presence of carious first permanent molars with the following characteristics:
• Deep caries extending to ≥2/3 of dentin.
• Positive response to cold testing.
• Clinical diagnosis of irreversible pulpitis (moderate or severe), with or without periapical periodontitis.
• Restorable tooth.
• Probing pocket depth and mobility within normal limits.
• No signs of pulpal necrosis, including sinus tract or swelling.

You may not qualify if:

• Insufficient bleeding after pulp exposure (indicating necrotic or partially necrotic pulp).
• Presence of systemic or medical conditions that may contraindicate participation.
• Teeth with unrestorable structure.
• Teeth showing signs of pulpal necrosis, such as the presence of a sinus tract or swelling.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Faculty of Dentistry

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

MeSH Terms

Conditions

Dental Caries

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

peter samir abdelshahed, assistant lecture

CONTACT

+201141859508; petersamir@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 12, 2024
• Study Start: October 10, 2024
• Primary Completion: January 1, 2026
• Study Completion: April 5, 2026
• Last Updated: December 17, 2024

Record last verified: 2024-09

Locations

EG (1)