Periapical HealingMTANCT07853183
Evaluation of Pulpotomy Techniques (Formocresol, Ferric Sulphate, Mineral Trioxide Aggregate)
A study testing FORMOCRESOL PULPOTOMY MATERIAL in people with Periapical Healing, run by Foundation University Islamabad.
Trial 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… Read more about this study
- Who is it for?
- Ages 4 to 9 years
- Conditions the study is for
- Periapical Healing
- What is being tested?
- FORMOCRESOL PULPOTOMY MATERIAL
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Jun 2027
- Phase
- Interventional
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 4 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- -
Who cannot join
- 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.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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 .
Read the 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.
- Conditions
- Periapical Healing
- Being tested
- FORMOCRESOL PULPOTOMY MATERIAL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FORMOCRESOL PULPOTOMY MATERIALDrug
Also called FERRIC SULPHATE PULPOTOMY MATERILA, MINERAL TRIOXIDE AGGREGATE 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
| Study group | Role | What they receive |
|---|---|---|
| PULPOTOMY MATERIAL | Experimental | 3 GROUPS GROUP 1:FORMOCRESOL,GROUP 2:FERRIC SULPHATE,GROUP 3 :MINERAL TRIOXIDE AGGREGATE Receives: Drug: FORMOCRESOL PULPOTOMY MATERIAL |
What is being measured
The primary outcome is the main question the study is designed to answer.
PAIN RELIEF
PAIN RELIEF ASSESMENT BY SCALE 0-10 (O no pain ,1-3 mild pain, 4-7 moderate pain ,8-10 extreme pain)
Measured: 2WEEKS ,1 MONTH ,6 MONTHS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periapical HealingStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Foundation University Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shoaib Rahim, Foundation University Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07853183
- Sponsor's protocol ID
- FUCD-PEADS- 2601
- Acronym
- MTA
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: PATIENT CONFIDENTIALITY NEEDS TO BE MAINTAINED.
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;