MedPath

Comparison of two plasma derivates as pulpotomy agents in human immature molars

Phase 1
Not yet recruiting
Conditions
Patients are normal and healthy. Only carious permanent molars will be treated.
Registration Number
CTRI/2020/06/025938
Lead Sponsor
Terna Dental College
Brief Summary

This study is a randomized, split mouth design, single blind trail comparing the efficacy of Platelet Rich Plasma (PRP) and Platelet Rich Fibrin (PRF) as a pulpotomy agent in 25 children 7 to 10 year old  with 50 young permanent molars present bilaterally in maxillary or mandibular arch. The study will be conducted in Terna Dental college, Navi mumbai, India. Pulpotomy procedure will be carried  out in young permanent molars. The patient will be recalled after 3, 6 and 12 months for clinical and radiographical evaluation. The primary outcome measures will be efficacy of both the materials at 3 months follow up. The secondary outcomes will be efficacy of both the materials as pulpotomy agent at 6 month and 12 month follow up.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
All
Target Recruitment
50
Inclusion Criteria
  • Large carious or mechanical exposure (more than 1 mm) of the vital coronal pulp 2.
  • Absence of symptoms indicative of advanced pulpal inflammation such as spontaneous pain or history of nocturnal pain 3.
  • Absence of clinical signs or symptoms suggesting a nonvital tooth such as suppurating sinus, soft tissue swelling.
  • Restorable tooth structure.
  • No evidence of external and/or internal root resorption 7.
  • No widening of periodontal ligament (PDL) space 8.
  • Absence of furcal or periapical radiolucency 9.
  • Absence of canal calcification or pulp stone.
Exclusion Criteria
  • Uncontrolled bleeding during the amputation of coronal pulp tissue 2.
  • Children with medical conditions or any associated systemic condition.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Comparison of clinical success of PRP and PRF3 months
Secondary Outcome Measures
NameTimeMethod
Comparison of clinical and radiographic success of PRP and PRF6 months and 12 months

Trial Locations

Locations (1)

Terna Dental College

🇮🇳

(Suburban), MAHARASHTRA, India

Terna Dental College
🇮🇳(Suburban), MAHARASHTRA, India
Dr Devendra Patil
Principal investigator
9930372999
dev1987endra@gmail.com

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.