NCT07853183

Brief Summary

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 .

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Oct 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Jun 2027

First Submitted

Initial submission to the registry

September 14, 2026

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 1, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

7 months

First QC Date

September 14, 2026

Last Update Submit

September 28, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

PULPOTOMY MATERIAL

EXPERIMENTAL

3 GROUPS GROUP 1:FORMOCRESOL,GROUP 2:FERRIC SULPHATE,GROUP 3 :MINERAL TRIOXIDE AGGREGATE

Drug: FORMOCRESOL PULPOTOMY MATERIAL

Interventions

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

Also known as: FERRIC SULPHATE PULPOTOMY MATERILA, MINERAL TRIOXIDE AGGREGATE PULPOTOMY MATERIAL
PULPOTOMY MATERIAL

Eligibility Criteria

Age4 Years - 9 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Symptomless carious teeth with vital pulp exposure
  • No clinical sign/symptoms of spontaneous and nocturnal pain, and tenderness to percussion or palpation, history of swelling or sinus tracts, pathologic mobility.
  • Teeth restorable.
  • No radiographic evidence of pulp degeneration such as internal or external resorption, inter-radicular or periapical bone destruction.
  • No clinical evidence of pulp degeneration such as excessive bleeding from root canals.
  • Teeth having no more than one third of their roots undergoing physiologic resorption.

You may not qualify if:

  • Teeth diagnosed with irreversible pulpitis
  • Teeth having Pulp necrosis / periapical abscess
  • Teeth with previous pulp therapy(pulpotomy/pulpectomy)
  • Children with systemic medical conditions that may affect healing or contraindicate treatment.
  • Children with special healthcare needs
  • Children with known allergy to any of the materials used in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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;

    BACKGROUND

Central Study Contacts

HUMA ZAHIR, FCPS

CONTACT

SANA QASIM, BDS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 14, 2026

First Posted

October 1, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

October 1, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

PATIENT CONFIDENTIALITY NEEDS TO BE MAINTAINED.