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A Study Comparing two materials ( Biodentin and Human Amniotic Membrane)for Treating Infected Developing Back Teeth in Children.

Comparative Evaluation of Clinical and Radiographic Outcomes between Biodentin and Human Amniotic Membrane in Pulpotomy of developing Mandibular Second Molars with Irreversible Pulpitis: A Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/106007
Enrollment
50
Registered
2026-03-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Health Condition 1: K00-K95- Diseases of the digestive system

Interventions

Intervention1: Human Amniotic Membrane Pulpotomy: Pulpotomy will be performed under local anesthesia and rubber dam isolation. Following access opening and removal of coronal pulp tissue, hemostasis w

Sponsors

DR VARNA R
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Participants will include healthy children aged 13 17 years (ASA I/II) with developing permanent second molars showing incomplete root formation and a vital pulp diagnosis suitable for pulpotomy. Teeth must have restorable crowns, no radiographic evidence of periapical or furcal radiolucency, no internal/external resorption, and the radicular pulp must exhibit controlled bleeding within 5 minutes after coronal pulp removal. Only teeth with adequate radiographic visibility and patients/guardians who provide informed consent and are willing to attend follow-up visits will be included.

Exclusion criteria

Exclusion criteria: Teeth will be excluded if they show signs of necrosis, uncontrolled radicular bleeding, irreversible pulpitis with swelling or sinus tract, internal or external resorption, or established periapical pathology. Patients with systemic diseases affecting healing (ASA III/IV), allergies to study materials, inability to return for follow-up, poor cooperation, recent antibiotic/steroid use that may confound outcomes, or teeth with previous pulpal procedures will be excluded. Teeth deemed unrestorable or compromised due to trauma, periodontal disease, or insufficient coronal structure will also be excluded.

Design outcomes

Primary

MeasureTime frame
Clinical Success of Pulpotomy Absence of spontaneous pain No swelling/sinus tract Positive vitality tests Timepoint: base line, 1 month, 3 months, 6 months

Secondary

MeasureTime frame
Radiographic Success Dentin bridge formation No periapical/furcal pathology Continued root development/apical closure Timepoint: base line, 1 month, 3 months, 6 months

Countries

India

Contacts

Public ContactDR VARNA R

Govt Dental College, Kozhikode

varnarajesh25@gmail.com9895673748

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026