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Assessing the role of three different materials in permanent teeth with incomplete root formation in children

Comparative Evaluation of Clinical and Radiographic Outcomes of Three different Scaffolds in Regenerative Endodontic Treatment: A Randomised Clinical Trial - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/07/069898
Enrollment
15
Registered
2024-07-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Health Condition 1: K004- Disturbances in tooth formation

Interventions

Intervention1: Concentrated Growth Factor (CGF): CGF wiLL be used as scaffold Preparation of CGF: â?¢ Two disposable 10 ml non-anticoagulant tubes and a centrifuge will be used. â?¢ 10ml of intravenou
accelerated for 30 seconds
centrifuged at 2700 rpm for 2 min, 2400 rpm for 4 min, 2700 rpm for 4 min, and 3000 rpm for 3 min
and decelerated for 36 secs to stop. â?¢ At the end of the automated pre-programmed cycle, the centrifuge tube will encompassa concoction of four different layers
the uppermost or the 1stlayer contained serum, the 2ndlayer was composed of a fibrin buffy coat, the 3rdlayer constituted the much needed growth factors, and lastly, the lowermost or the 4thlayer was

Sponsors

ICMR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children with non-vital immature permanent teeth requiring endodontic treatment ASA I and II Patient Compliant Patient and Parent

Exclusion criteria

Exclusion criteria: Post/core required for final restoration Patient Allergic to any medicaments or antibiotics to be used during the procedure

Design outcomes

Primary

MeasureTime frame
Clinical outcomes Resolution of signs and symptoms like pain, swelling, pus drainage, tooth mobility Tooth survival Restoration of function 2. Radiographic outcomes Resolution of periapical pathologyTimepoint: Time intervals At Baseline 1 Month Post Procedure 3 Months Post Procedure 6 Months Post Procedure 1 year Post Procedure

Secondary

MeasureTime frame
1 Clinical outcomes Positive response to pulp vitality tests 2. Radiographic outcomes Thickening of the dentinal walls of the root canals Continuation of root development Closure of the root apexTimepoint: Time intervals At Baseline 1 Month Post Procedure 3 Months Post Procedure 6 Months Post Procedure 1 year Post Procedure

Countries

India

Contacts

Public ContactAditya Saxena

ITS Dental College Hospital and Research Centre

adisaxen85@gmail.com8527969884

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026