PulpotomyPhase 3NCT07522268
Laser Pulpotomy: a Modern-non Pharmacological Alternate to Ferric Sulphate Pulpotomy
A Phase 3 study testing Group B (Diode Laser) and (Ferric Sulphate) in people with Pulpotomy, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
Trial summary
Diode lasers could be a viable alternative to ferric sulphate in pulpotomy. Read more about this study
- Who is it for?
- Ages 4 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulpotomy
- What is being tested?
- Group B (Diode Laser) and (Ferric Sulphate)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2019to 1 Jan 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Shaheed Zulfiqar Ali Bhutto Medical University
Islamabad, 44000
About this study
Diode lasers could be a viable alternative to ferric sulphate in pulpotomy.
Read the 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.
- Conditions
- Pulpotomy
- Being tested
- Group B (Diode Laser), (Ferric Sulphate)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group B (Diode Laser)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A (Ferric Sulphate) | Active comparator | Group A (Ferric Sulphate) Receives: 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. Receives: Procedure: Group B (Diode Laser) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1,3,6,9 and 12 months interval
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Jun 2019
- Primary completion1 Jan 2021
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PulpotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RANA AHMAD, Shaheed Zulfiqar Ali Bhutto Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07522268
- Sponsor's protocol ID
- F.1-1/2015/ERB/SZABMU/418
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Pulpotomy: a Modern-non Pharmacological Alternate to Ferric Sulphate Pulpotomy
- ClinicalTrials.gov ID
- NCT07522268
- Acronym / sponsor ID
- F.1-1/2015/ERB/SZABMU/418
- Conditions
- Pulpotomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Shaheed Zulfiqar Ali Bhutto Medical UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diode lasers could be a viable alternative to ferric sulphate in pulpotomy.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Ferric Sulphate) | Active comparator | Combination Product: (Ferric Sulphate)Group A (Ferric Sulphate) |
| (Diode Laser) | Experimental | Procedure: Group B (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. |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- Periapical Abscess
- Necrotic pulp
- Teeth nearing exfoliation
- Non cooperative patients
- Patients with poor oral hygiene
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Group B (Diode Laser)Group B (Diode Laser) | Procedure or surgery | (Diode Laser) |
| (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. | Combination product | Group A (Ferric Sulphate) |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Group B (Diode Laser) and (Ferric Sulphate) in people with Pulpotomy, run by Shaheed Zulfiqar Ali Bhutto Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of Pain or tenderness or mobility (time frame: 1,3,6,9, and 12 months intervals). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.