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PulptomyCTNCT07324928

Effect of Ferric Sulphate and Putty MTA as Pulpotomy Agent in Vital Primary Teeth

A study testing Ferric sulphate and Putty MTA in people with Pulptomy and Dental Caries, run by University of Jazan at 1 site in Saudi Arabia.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

The pulp in primary teeth has a high potential for repair because of high degree of cellularity and vascularity. The rationale for the pulpotomy procedure is that the radicular pulp tissue is healthy and capable of healing after surgical amputation of the affected or the infected coronal pulp. Read more about this study

Who is it for?
Ages 6 to 10 yearsHealthy volunteers can take part
Conditions the study is for
Pulptomy, Dental Caries, Pulp Therapy
What is being tested?
Ferric sulphate and Putty MTA
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSaudi Arabia
Study dates
7 Mar 2026to 28 May 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 6 to 10 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy children with no systemic illness, allergies
  • Co-operative child
  • Patient requiring pulpotomy on deciduous molars with carious /mechanical pulp exposure
  • children with proper parental consent
  • No clinical or radiographical signs of pulp pathoses
  • Possibility of proper restoration of tooth after the procedure
  • Haemostasis should be easily achievable after pulp amputation

Who cannot join

  • Children with systemic illness and allergy
  • Un co-operative child
  • clinical or radiographical signs of pulp pathoses
  • unrestorable tooth
  • Haemostasis not achieved after pulp amputation

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Saudi Arabia1 site
  • College of Dentistry

    Jizan, Jazan Region, 45142

Other trials in Saudi Arabia

About this study

Official title: Evaluate and Compare the Effect of Ferric Sulphate and Putty MTA as Pulpotomy Agent in Vital Primary Teeth

The pulp in primary teeth has a high potential for repair because of high degree of cellularity and vascularity. The rationale for the pulpotomy procedure is that the radicular pulp tissue is healthy and capable of healing after surgical amputation of the affected or the infected coronal pulp. There is ample information about pulpotomy in deciduous molars using formocresol, glutaraldehyde, electrosurgery, ferric sulphate, calcium hydroxide, MTA etc. The vital pulpotomy process using formocresol has been widely accepted in primary tooth pulp therapy because of its simplicity and good prognosis. However, much concern as arisen over the mutagenic and carcinogenic potential of formaldehyde containing products, the cytotoxic effects of formocresol and the possible diffusion into the surrounding and systemic tissues. In order to avoid the possible harmful effects of formocresol; other pulpotomy agents for vital pulpotomy procedure is being sought such as ferric sulphate and MTA with promising results due to their advantages such as devitalization and regenerative agents respectively.

Ferric sulphate [Fe2(SO4)3] as a 15.5% solution is a coagulative and local hemostatic agent.

Read more

Ferric sulphate is a material with minimal devitalization and non-induction of pulp tissue. It is used as a coagulative and hemostatic retraction agent. Ferric sulfate is proposed as a pulpotomy agent on the theory that its mechanism of controlling hemorrhage might minimize the chances for inflammation. Ranly proposes the possibility that the metal-protein clot at the surface of the pulp stumps may act as a barrier to the irritative components of the sub-base which helps in minimizing the complications from the material. The hemostatic properties of ferric sulfate and the favorable pulpal response make it a promising medicament for pulpotomy. Erdem AP et al in their study observed no significant differences among 3 experimental materials MTA, Formocresol and Ferric sulphate. Fei AL et al observed clinical ad radiographic success than the Formocresol group at the end of one year.

Mineral trioxide aggregate (MTA) is one such regenerative material recognized as the reference material for conservative pulp vitality treatments in primary teeth, with high pulpotomy success rates (90%-100%) in clinical, radiographic, and histopathologic studies. However, MTA has difficult handling characteristics, contains heavy metals such as alumina and bismuth oxide, and is expensive. Technological improvements in the medical meteorology led to development and innovations in bioceramic nanotechnology (Bioceramics) which exhibit excellent biocompatibility with properties in unison with hydroxyapatite. Recently, bioceramic putty, a calcium silicate based nanoparticulate material, was introduced into dentistry as a root repairing material. It is an insoluble, radiopaque, aluminum free, and zirconium oxide incorporated material developed for potential dental surgery applications. Moreover, it stimulates the deposition of hydroxyapatite on its surface when exposed to tissue fluids, forms well organized dentin, and has low cytotoxicity. Despite its ease of handling, high viscosity, shorter setting time, better physical properties over MTA and the biomimetic property of bioceramics, its clinical application in the field of vital pulp therapy in primary teeth has not been explored so far. Kumar KR et al in their study showed clinical success rate of 95 % and radiographic success rate of around 90% with MTA.

Some studies have reported internal resorption seen with ferric sulphate pulpotomy, sensitivity, premature tooth loss , furcation radiolucency, gingival swelling but not attributed the exact reason for the same. They attributed to tooth selection for the procedure. Hence proper tooth selection is a criteria for the success of pulpotomy.

Read the detailed description

Pilot study will not be conducted as we are not testing the feasibility of the methodology.

This study will be performed on 60 patients aged 6 to 10 years attending the clinics of department of paediatric dentistry, college of dentistry, Jazan university will be considered for the study.

Before starting; the procedure will be explained; verbal and written consent will be obtained by the parent or guardian. After obtaining consent a total of 60 molars will be randomly divided into two groups, Group A with ferric sulphate and Group B with Putty MTA using a lottery randomization technique.

Pulpotomy will be done in both the groups followed by GIC restoration. Immediate post operative radiograph will be taken for all the patients. The patients will be recalled at 1month and 3 month and 6-month interval for clinical and radiographic evaluation.

In recall visits all the teeth will be evaluated to grade them as either success or failure based on the clinical and radiographic criteria. This will be evaluated by investigators unaware of the group assignment.

Criteria for evaluating the success:

Teeth which presented with no symptoms of pain. Tenderness to percussion, swelling, fistulation, or pathologic mobility clinically as well as no evidence of radicular radiolucency, internal or external root resorption or periodontal ligament space widening radiographically will be considered successful. Any tooth which showed signs of symptoms of failure will be treated with pulpectomy

Being tested
Ferric sulphate, Putty MTA
Medical subject headings
Dental Caries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ferric sulphateProcedure or surgery

    already described

  • Putty MTAProcedure or surgery

    already described

Study groups in NCT07324928
Study groupRoleWhat they receive
Group A (Ferric Sulphate)Experimentalalready described
Receives: Procedure: Ferric sulphate
Group B ( Putty MTA)Experimentalalready described
Receives: Procedure: Putty MTA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical criteria

    Clinical Teeth which presented with

    • no symptoms of pain.
    • Tenderness to percussion,
    • swelling,
    • fistulation, or
    • pathologic mobility

    Measured: 1 month, 3 month , 6 month

  2. Radiographic criteria

    • Evidence of radicular radiolucency,
    • Internal or external root resorption
    • Periodontal ligament space widening

    Measured: 1 month, 3 month, 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2026
  2. Study start7 Mar 2026
  3. Primary completion28 May 2026 (estimated)
  4. Study completion28 May 2026 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07324928
Sponsor's protocol ID
Jazan college of Dentistry
Acronym
CT
Status last verified
Mar 2026
First submitted
23 Dec 2025
Last updated
9 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Ferric sulphate and Putty MTA in people with Pulptomy and Dental Caries, run by University of Jazan at 1 site in Saudi Arabia.

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 7 inclusion and 5 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: enrolling by invitation, as of the sponsor's last update on 9 Mar 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 Saudi Arabia. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

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?

Clinical criteria (time frame: 1 month, 3 month , 6 month). 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 9 Mar 2026.

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