Evaluation of Pulpotomy Techniques (Formocresol, Ferric Sulphate, Mineral Trioxide Aggregate) (MTA)

Evaluation of Pulpotomy Techniques (Formocresol ,Ferric Sulphate, Mineral Trioxide Aggregate)

The goal of this interventional study is to evaluate the different materials used for pulpotomy procedures in deciduous molars. this will help us find out which medicament is more effective in releving which medicament is more effective in releving pain and resolution of signs of infection.it will help us find out less chair time for procedure and cooperation of child .

Study Overview

• Status: Not yet recruiting
• Conditions: Periapical Healing
• Intervention / Treatment: Drug: FORMOCRESOL PULPOTOMY MATERIAL

Detailed Description

This interventional study will randomly allocate patients in three groups ( Formocresol, Ferric Sulphate , Mineral trioxide aggregate) based on the inclusion criteria procedure will be started by local local anesthesia with 2% lignocaine. Once anesthesia is achieved caries removal and access opening will be done with a round carbide bur number 6 or 8 and 330 respectively. Coronal pulp tissue will be removed by sharp spoon excavator. Hemostasis will be achieved with a sterile cotton pellet soaked with saline.Teeth in which hemostasis could not be achieved with in 5 minutes will be excluded from the study.these initial steps will be same for all three groups wile subsequent steps will varry according to the treatment group.

For formocresol group a sterile cotton pellet soaked with formocrsol will be placed on radicular pulp stumps for 5 minutes and then removed. Later the pulp stumps will be covered by zinoxide eugenol cement and tooth restored with glass ionomer cement.

For ferric suplahte a solution of 15.5% will be applied on sterile cotton and placed on pulp stumps for 15 seconds .later the pulp stumps will be covered by zinc oxide eugenol cement and tooth restored with glass ionomer cement.

For mineral trioxide aggregate pulpotomy pulp stumps will be covered with mineral trioxide aggregate and tooth will be restored with glass ionomer cement.

Patient will then be recalled for follow up at 2 weeks ,1 month and 6 months. Assessment will be done clinically and radiographically to determine treatment sucess and failure.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: HUMA ZAHIR, FCPS; Phone Number: 923360119081; Email: HUMA.ZAHIR@FUI.EDU.PK
• Study Contact Backup: Name: SANA QASIM, BDS; Phone Number: 03338885560; Email: SANAQASIM@HOTMAIL.COM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Symptomless carious teeth with vital pulp exposure

2. No clinical sign/symptoms of spontaneous and nocturnal pain, and tenderness to percussion or palpation, history of swelling or sinus tracts, pathologic mobility.

3. Teeth restorable.

4. No radiographic evidence of pulp degeneration such as internal or external resorption, inter-radicular or periapical bone destruction.

5. No clinical evidence of pulp degeneration such as excessive bleeding from root canals.

6. Teeth having no more than one third of their roots undergoing physiologic resorption.

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Exclusion Criteria:

1. Teeth diagnosed with irreversible pulpitis

2. Teeth having Pulp necrosis / periapical abscess

3. Teeth with previous pulp therapy(pulpotomy/pulpectomy)

4. Children with systemic medical conditions that may affect healing or contraindicate treatment.

5. Children with special healthcare needs

6. Children with known allergy to any of the materials used in the study.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PULPOTOMY MATERIAL; 3 GROUPS GROUP 1:FORMOCRESOL,GROUP 2:FERRIC SULPHATE,GROUP 3 :MINERAL TRIOXIDE AGGREGATE	Drug: FORMOCRESOL PULPOTOMY MATERIAL; FORMOCRESOL PULPOTOMY MATERIAL FOR 5MINUTES PACKED WITH STERILE COTTON PELLETS ON PULP STUMPS FERRIC SULPHATE 15.5 % PACKED ON PULP STUMPS WITH STERILE COTTON PELLET FOR 15 SECONDS. MINERAL TRIOXIDE AGGREGATE PLACED ON PULP STUPMS; Other Names: FERRIC SULPHATE PULPOTOMY MATERILA; MINERAL TRIOXIDE AGGREGATE PULPOTOMY MATERIAL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PAIN RELIEF	PAIN RELIEF ASSESMENT BY SCALE 0-10 (O no pain ,1-3 mild pain, 4-7 moderate pain ,8-10 extreme pain)	2WEEKS ,1 MONTH ,6 MONTHS

Collaborators and Investigators

• Sponsor: Foundation University Islamabad

Publications and helpful links

General Publications

• Igna A. Vital pulp therapy in primary dentition: Pulpotomy-a 100-year challenge. Children. 2021;8(10). 2. A randomized controlled trial comparing - PubMed Mobile [Internet]. Available from: http://www.ncbi.nlm.nih.gov/m/pubmed/20801246/?i=4&from=leaver+maher 3. Roy S, Garg N, Pathivada L, Choudhary R, Kaur H, Yeluri R. Comparative Evaluation of Low-level Diode Laser and Electrosurgical Pulpotomy in Primary Molars. Int J Clin Pediatr Dent. 2023;16(4):612-8. 4. Tewari N, Goel S, Mathur VP, O'Connell AC, Johnson RM, Rahul M, et al. Success of medicaments and techniques for pulpotomy of primary teeth: An overview of systematic reviews. Int J Paediatr Dent. 2022;32(6):828-42. 5. Eshghi A, Hajiahmadi M, Nikbakht MH, Esmaeili M. Comparison of Clinical and Radiographic Success between MTA and Biodentine in Pulpotomy of Primary Mandibular Second Molars with Irreversible Pulpitis: A Randomized Double-Blind Clinical Trial. Int J Dent. 2022;2022. 6. Philip N, Cherian JM, Mathew MG, Thomas AM, Jodhka S, John N, et al. Treatment outcomes of pulpotomy versus pulpectomy in vital primary molars diagnosed with symptomatic irreversible pulpitis: protocol for a non-inferiority randomised controlled trial. BMC Oral Health [Internet]. 2024;24(1):1-10. Available from: https://doi.org/10.1186/s12903-024-04411-6 7. Yildiz E, Tosun G. Evaluation of formocresol , calcium hydroxide , ferric sulfate , and MTA primary molar pulpotomies. 2019;8(2). 8. Guo J, Zhang N, Cheng Y. Comparative efficacy of medicaments or techniques for pulpotomy of primary molars: a network meta-analysis. Clin Oral Investig. 2023;27(1):91-104. 9. Simonoska J, Bjelica R, Dimkov A, Simjanovska J, Gabrić D, Gjorgievska E. Efficacy of Laser Pulpotomy vs. Conventional Vital Pulpotomy in Primary Teeth: A Comparative Clinical Analysis. Children. 2025;12(3):1-11. 10. Pulpotomy E. Original Article. 2018;

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: September 14, 2026
• First Submitted That Met QC Criteria: September 28, 2026
• First Posted (Actual): October 1, 2026

Study Record Updates

• Last Update Posted (Actual): October 1, 2026
• Last Update Submitted That Met QC Criteria: September 28, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: FUCD-PEADS- 2601

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

PATIENT CONFIDENTIALITY NEEDS TO BE MAINTAINED.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No