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Completed

NCT Number: NCT07522268

Laser Pulpotomy: a Modern-non Pharmacological Alternate to Ferric Sulphate Pulpotomy

Diode lasers could be a viable alternative to ferric sulphate in pulpotomy.

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Key information

Conditions

Pulpotomy

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shaheed Zulfiqar Ali Bhutto Medical University

Islamabad, 44000, Pakistan

About this study

Ferric sulphate (FS) has recently replaced formocresol as it has comparable clinical and radiographic outcomes, and is more biocompatible, making it the current material of choice. 6,7 However, some histological studies report inflammatory response caused by FS in the remaining pulp, similar to FC, which may lead to internal resorption and eventually, premature tooth exfoliation.

In contrast to ferric sulphate, diode lasers due to their better antimicrobial action, cell regenerative properties, localized/controlled, and quick mechanism of action, are now being considered as an effective method of pulpotomy in dentistry.

Even with several studies that have been conducted on the efficacy and success of laser pulpotomy, there is still a need for additional data and evidence that would further advocate its use in pulpotomy. Furthermore, there hasn't been any such study conducted in this region, which also highlights the importance of this study.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Primary molars( either mandibular or maxillary or both) of children in the age range of 4 to 8 years.
  • Absence of spontaneous pain, associated swelling, tenderness to percussion, pathological mobility, sinus tract

Exclusion criteria

  • Periapical Abscess
  • Necrotic pulp
  • Teeth nearing exfoliation
  • Non cooperative patients
  • Patients with poor oral hygiene
  • Parents/patients not willing to be a part of study
  • Any drug allergies
  • Any medical history contraindicating the pulp treatment

Treatment and study plan

Group B (Diode Laser)

Procedure

Group B (Diode Laser)

(Ferric Sulphate)

Combination Product

After hemostasis was achieved a sterile cotton pellet soaked in 15.5% ferric sulphate solution (Quickstat-FS, USA) was placed over amputated root stumps for 15-20 seconds.

Primary outcomes

  1. Presence of Pain or tenderness or mobility

    Time frame: 1,3,6,9, and 12 months intervals

    Teeth will be scored as clinical success if they had absence of pain, tenderness, pathological mobility, and sinus or abscess formation.

    Presence of any of these signs and symptoms will be scored as clinical failure.

  2. Presence of resorption or periapical pathology

    Time frame: 1,3,6,9 and 12 months interval

    Radiographic assessment included evaluation of pathological external or internal root resorption, periapical or inter-radicular radiolucency and widening of the periodontal ligament (PDL). Presence of any of these signs on the periapical radiograph will be recorded as a radiographic failure.

Sponsors and collaborators

Lead sponsor

Shaheed Zulfiqar Ali Bhutto Medical University

Other

Registry information

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 13, 2026
Registry last updated
Apr 14, 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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