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

NCT07522268 | Completed Phase 3 DMC

• 1 other identifier: F.1-1/2015/ERB/SZABMU/418
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pulpotomy

Outcome Measures

Primary Outcomes (2)

• Presence of Pain or tenderness or mobility

  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.

  1,3,6,9, and 12 months intervals

• Presence of resorption or periapical pathology

  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.

  1,3,6,9 and 12 months interval

Study Arms (2)

Group A (Ferric Sulphate)

ACTIVE COMPARATOR

Group A (Ferric Sulphate)

Combination Product: (Ferric Sulphate)

(Diode Laser)

EXPERIMENTAL

A diode laser (Fona, Germany) with a surgical fiber optic tip of 0.4-0.5mm diameter was used and pulp was ablated till the level of the canal orifice. Settings of laser were of wavelength between 810-980nm, set at 3W power in continuous wave/pulse mode for not more than 2-3 seconds. The operator, assistant and the patient were wearing protective eye wear during this procedure. Afterwards MTA (Cerkamed, Poland) was placed in 1mm thickness over the amputated pulp.

Procedure: Group B (Diode Laser)

Interventions

Group B (Diode Laser) PROCEDURE

Group B (Diode Laser)

(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.

Group A (Ferric Sulphate)

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shaheed Zulfiqar Ali Bhutto Medical University: lead

Study Sites (1)

Shaheed Zulfiqar Ali Bhutto Medical University

Islamabad, 44000, Pakistan

Location

MeSH Terms

Interventions

Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor (Clinical)

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 13, 2026
• Study Start: June 1, 2019
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

PA (1)