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.
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.
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
- Conditions
- Pulptomy, Dental Caries, Pulp Therapy
- 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 group | Role | What they receive |
|---|---|---|
| Group A (Ferric Sulphate) | Experimental | already described Receives: Procedure: Ferric sulphate |
| Group B ( Putty MTA) | Experimental | already described Receives: Procedure: Putty MTA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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.
- First posted8 Jan 2026
- Study start7 Mar 2026
- Primary completion28 May 2026 (estimated)
- Study completion28 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PulptomyStudies 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 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)
Sponsor and investigators
- Lead sponsor
- University of Jazan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, satish vishwanathaiah, University of Jazan
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate and Compare the Effect of Ferric Sulphate and Putty MTA as Pulpotomy Agent in Vital Primary Teeth
- ClinicalTrials.gov ID
- NCT07324928
- Acronym / sponsor ID
- CT / Jazan college of Dentistry
- Conditions
- Pulptomy, Dental Caries, Pulp Therapy
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of JazanOther government
- Study start
- 7 Mar 2026 (actual)
- Primary completion
- 28 May 2026 (estimated)
- Study completion
- 28 May 2026 (estimated)
- First posted
- 8 Jan 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.
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.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (Ferric Sulphate) | Experimental | Procedure: Ferric sulphatealready described |
| Group B ( Putty MTA) | Experimental | Procedure: Putty MTAalready described |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Ferric sulphatealready described | Procedure or surgery | Group A (Ferric Sulphate) |
| Putty MTAalready described | Procedure or surgery | Group B ( Putty MTA) |
Primary outcome
Clinical criteria
Time frame: 1 month, 3 month , 6 month
Clinical Teeth which presented with * no symptoms of pain. * Tenderness to percussion, * swelling, * fistulation, or * pathologic mobility
Radiographic criteria
Time frame: 1 month, 3 month, 6 month
* Evidence of radicular radiolucency, * Internal or external root resorption * Periodontal ligament space widening
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Pulptomy
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.
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 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.