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

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

Study Overview

• Status: Completed
• Conditions: Pulpotomy
• Intervention / Treatment: Combination product: (Ferric Sulphate); Procedure: Group B (Diode Laser)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 3

Contacts and Locations

Study Locations

• Pakistan
  • Islamabad, Pakistan, 44000
    • Shaheed Zulfiqar Ali Bhutto Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A (Ferric Sulphate)	Combination product: (Ferric Sulphate); 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.
Experimental: (Diode Laser); 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); Group B (Diode Laser)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Shaheed Zulfiqar Ali Bhutto Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): January 1, 2021

Study Registration Dates

• First Submitted: March 27, 2026
• First Submitted That Met QC Criteria: April 3, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Equipment and Supplies; Lasers; Optical Devices; Radiation Equipment and Supplies; Lasers, Semiconductor
• Other Study ID Numbers: F.1-1/2015/ERB/SZABMU/418

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No