FindTrial
Sign In

comparing two innovative treatments to save adult molars with severe tooth pain.

Outcome of pulpotomy with human amniotic membrane compared to platelet rich fibrin in mature human permanent molars with symptomatic irreversible pulpitis :a randomized controlled trial - nil

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095006
Enrollment
60
Registered
2025-09-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K040- Pulpitis

Interventions

Intervention1: Pulpotomy with human amniotic membrane: The human amniotic membrane (2 2 cm) freeze dried ,which is commercially available from Tata Memorial Hospital, Mumbai will be purchased.The
Mani Inc, Utsunomiya, Japan) at high speed, followed by a sterile low speed carbide round bur (No # 4 andNo # 6 (SSWhite, Lakewood, NJ), on nearing the pulp. Access opening will be done with No # 4 an
Mani Inc, Utsunomiya, Japan) at high speed, followed by a sterile low speed carbide round bur (No # 4 andNo # 6 (SSWhite, Lakewood, N

Sponsors

Adhya Shyam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Permanent molars with symptomatic irreversible pulpitis having spontaneous/lingering/night pain. Patients above 13 years. Patients and parents of patients below the age of 18 years willing to give assent and informed consent and respectively.

Exclusion criteria

Exclusion criteria: Teeth with clinical signs or symptoms indicating pulp degeneration including swelling, sinus tract, tooth mobility and tenderness to percussion Teeth with periapical lesion ,crestal bone loss, subgingival carious lesions, internal/external resorption, calcified canals Patients with uncontrolled systemic disease

Design outcomes

Primary

MeasureTime frame
To compare the outcome of pulpotomy using human amniotic membrane and platelet rich fibrin as pulpotomy agent in mature human permanent molars with irreversible pulpitis assessed by clinical criteria at 3, 6 and 12 months and radiographic criteria at 6 and12 months follow up. Timepoint: To compare the outcome of pulpotomy using human amniotic membrane and platelet rich fibrin as pulpotomy agent in mature human permanent molars with irreversible pulpitis assessed by clinical criteria at 3, 6 and 12 months and radiographic criteria at 6 and12 months follow up.—

Secondary

MeasureTime frame
Clinical assessment of post operative sensitivity, visible coronal discoloration, radiographically visible dentin bridge formation,diffuse canal calcifications assessed as present or absent.Timepoint: clinical criteria at 3, 6 and 12 months and radiographic criteria at 6 and12 months follow up.—

Countries

India

Contacts

Public ContactAdhya shyam

Government Dental College Thiruvananthapuram

shijidinakaran@gmail.com9895402488

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026