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Comparison of three different materials used in pulpotomy of primary teeth

Comparative clinical evaluation of silk fibroin and simvastatin gel in comparison to mineral trioxide aggregate as a pulpotomy material in primary molars a randomised clinical trial - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/107722
Enrollment
45
Registered
2026-04-07
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: Silk Fibroin: New innovative material that is silk fibroin which will be used as intervention for pulpotomy medicament after removal of coronal pulp silk fibroin will be placed over vi

Sponsors

Sakshi Meghwal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Clinical Criteria Healthy patients between the age group of 3 to 9 years Patients willing to participate in the study Patients exhibiting a Frankls behavior rating scale score of 3 or 4 positive or definitely positive Primary teeth with a healthy periodontium History of localized pain of short duration that resolves following removal of the offending mechanical or thermal stimulus Achievement of hemostasis within 3 to 5 minutes during the procedure Clinical absence of abscess fistula sinus tract swelling or pathological mobility Radiographic Criteria Deep carious lesion presenting as coronal radiolucency extending beyond two-thirds of the dentin and approaching the pulp Absence of radiographic evidence of periradicular or furcal pathology Absence of pathological internal or external root resorption

Exclusion criteria

Exclusion criteria: Clinical Criteria Medically compromised patients including children with special health care needs Any clinical sign of tooth mobility grade 2 or 3 as per Miller s criteria Tooth that cannot be restored clinically History of lingering and spontaneous or nocturnal pain persisting after removal of the causative stimulus and associated with sensitivity to heat and tenderness on percussion Vestibular obliteration swelling or draining sinus tract in relation to the tooth Grossly carious teeth with unrestorable crown structure Radiographic Criteria Shallow or moderate carious lesion with coronal radiolucency confined to the outer or middle third of dentin and not approaching the pulp Presence of radiographic signs suggestive of periradicular or furcal pathology Presence of pathological internal and external root resorption

Design outcomes

Primary

MeasureTime frame
The clinical success rate regarding the presence of normal mucosa without abnormal mobility pain or sensitivity to percussion Timepoint: 1 3 6 months

Secondary

MeasureTime frame
The radiographic success rate regarding absence of periradicular or furcal pathology, absence of pathological internal or external root resorption Timepoint: 1 3 6 months

Countries

India

Contacts

Public ContactDr Suruchi Juneja Sukhija

Surendera Dental College and Research Institute

drsuruchijuneja@gmail.com9829365880

Outcome results

None listed

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