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

NCT07324928 | Enrolling By Invitation

• 1 other identifier: Jazan college of Dentistry
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pulptomy; Dental Caries; Pulp Therapy

Outcome Measures

Primary Outcomes (2)

• Clinical criteria

  Clinical Teeth which presented with * no symptoms of pain. * Tenderness to percussion, * swelling, * fistulation, or * pathologic mobility

  1 month, 3 month , 6 month

• Radiographic criteria

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

  1 month, 3 month, 6 month

Study Arms (2)

Group A (Ferric Sulphate)

EXPERIMENTAL

already described

Procedure: Ferric sulphate

Group B ( Putty MTA)

EXPERIMENTAL

already described

Procedure: Putty MTA

Interventions

Ferric sulphate PROCEDURE

already described

Group A (Ferric Sulphate)

Putty MTA PROCEDURE

already described

Group B ( Putty MTA)

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Jazan: lead

Study Sites (1)

College of Dentistry

Jizan, Jazan Region, 45142, Saudi Arabia

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 23, 2025
• First Posted: January 8, 2026
• Study Start: March 7, 2026
• Primary Completion (Estimated): May 28, 2026
• Study Completion (Estimated): May 28, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)