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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-9
SponsorMansoura University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children aged 6 to 9 years.

Non-contributory medical history (healthy otherwise).

Deep caries extending to ≥2/3 of dentin.

Positive response to cold testing.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • MTA Pulpotomy without photobiomodulation

    Procedure/Surgery

    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 with Photobiomodulation (LLLT)

    Procedure/Surgery

    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.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: MTA Pulpotomy without PhotobiomodulationActive comparator 1 intervention
Group B: MTA Pulpotomy with PhotobiomodulationExperimental treatment 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Radiographic Healing

Assessment of radiographic evidence of healing, including no periapical rarefaction, root resorption, or new furcal pathosis. Success is determined by achieving a PAI (Periapical Index) score of 1 or 2, or reduction in PAI score if preoperative rarefaction is present. Periapical Index (PAI) Scale: 1 to 5 Interpretation: 1: Normal periapical structures (better outcome) 5: Severe changes with evident bone destruction (worse outcome).

Time frame
15 months post-treatment (assessed at 6, 12, and 15 months).
2

Root Development Progression

Radiographic evaluation of root maturity and the formation of a hard tissue bridge

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

Other outcomes

1

Postoperative Pain Intensity

Measured using the Wong-Baker Faces Pain Rating Scale to assess postoperative pain levels. Wong-Baker Facial Pain Rating Scale Scale: 0 to 10 Interpretation: 0: No pain (better outcome) 10: Worst pain imaginable (worse outcome).

Time frame
2 days post-treatment.

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