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Clinical Trials/CTRI/2024/11/077158
CTRI/2024/11/077158
Not yet recruiting
Phase 4

3D printed POLYLACTIC-CO-GLYCOLIC ACID(PLGA)scaffolds for bone regeneration in osseous defects of maxilla and mandible.

ANIL NERUKONDA INSTITUTE OF DENTAL SCINCES1 site in 1 country10 target enrollmentStarted: December 10, 2024Last updated:

Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
ANIL NERUKONDA INSTITUTE OF DENTAL SCINCES
Enrollment
10
Locations
1
Primary Endpoint
Efficacy of PLGA SCAFFOLDS

Overview

Brief Summary

Craniomaxillofacial surgeries often involve complex bone reconstructions due to trauma, congenital anomalies, or tumor resections. Current approaches have limitations in terms of graft availability, donor site morbidity, and suboptimal outcomes. PLGA is a biocompatible and biodegradable polymer widely used in medical applications. Utilizing PLGA scaffolds for bone regeneration could offer a minimally invasive and effective alternative  in maxilla and mandible.

Objective: This proposal aims to investigate the efficacy and safety of Poly (lactic-co-glycolic acid) (PLGA) scaffolds as a regenerative solution for bone defects in craniomaxillofacial surgeries. The project will assess the ability of PLGA scaffolds to promote bone regeneration, accelerate healing, and improve patient outcomes, while adhering to the highest ethical standards.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 45.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Patients with Cystic Defects of the Maxilla and Mandible after cyst enucleation Primary defects after cyst enucleation less than 4cm.

Exclusion Criteria

  • Patients with sytemic disease patients on calcium and vitamin d supplementation.

Outcomes

Primary Outcomes

Efficacy of PLGA SCAFFOLDS

Time Frame: assessment of bone formed at 4th week and 12th week with CT evaluation

Secondary Outcomes

  • assessment of bone density formed at 4th week and 12th by histomorphic analysis(4th week,12th week.)

Investigators

Sponsor
ANIL NERUKONDA INSTITUTE OF DENTAL SCINCES
Sponsor Class
Government funding agency
Responsible Party
Principal Investigator
Principal Investigator

Dr.Venkata ramana murthy v

anil neerukonda isntitute of dental sciences

Study Sites (1)

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