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A Clinical Study Comparing Amniotic Membrane and Platelet-Rich Fibrin in Regenerative Treatment of Immature Non-Vital Front Teeth

A COMPARATIVE STUDY TO ASSESS THE EFFICACY OF HUMAN AMNIOTIC MEMBRANE AND PLATELET-RICH FIBRIN AS INTRACANAL SCAFFOLDS IN REGENERATIVE ENDODONTIC TREATMENT OF IMMATURE NECROTIC PERMANENT MAXILLARY ANTERIOR TEETH: A RANDOMIZED CLINICAL TRIAL - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/106750
Enrollment
20
Registered
2026-03-23
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

None listed

Interventions

Intervention1: GROUP I: Patients who will be receiving human amniotic membrane as scaffold for regeneration: After disinfection phase Trim AM membrane to canal size. Place in the canal 2 3 mm apical
centrifuge as per standardized protocol. Prepare PRF membrane by gentle compression. Place PRF at similar level (2 3 mm below CEJ). Place MTA and coronal seal as above.

Sponsors

DR AMRITHA P K
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 13 25 years Immature permanent teeth Maxillary anterior teeth with open apices Necrotic pulp confirmed by history clinical signs and lack of response to sensibility tests Presence of periapical radiolucency suggestive of apical periodontitis less than 5mm radius Tooth must be structurally restorable Patients willing to return for scheduled follow ups Written informed consent from parent or guardian and assent from minors

Exclusion criteria

Exclusion criteria: Systemic diseases affecting healing such as uncontrolled diabetes immunocompromised states Known allergy to study materials like local anesthetic MTA components Teeth with root fractures or severe crown destruction Teeth with previous apexification or regenerative attempts Teeth with periapical radiolucency greater than 5mm radius Patients on medications affecting bleeding or healing Pregnant or lactating individuals Failure to obtain consent or assent

Design outcomes

Primary

MeasureTime frame
No pain swelling sinus tract or mobilityTimepoint: Baseline 1 week 3 months 6 months 9 months 12 months

Secondary

MeasureTime frame
Increase in root length (measured from CEJ to radiographic apex) Apical closure (open/closed) Periapical healing (PAI score) Timepoint: Baseline 1 week 3 months 6 months 9 months 12 months

Countries

India

Contacts

Public ContactDR AMRITHA P K

Govt Dental College Kozhikode

drprasanthb@gmail.com9447229506

Outcome results

None listed

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