| CTRI Number |
CTRI/2024/11/077158 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
20/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
3D PRINTED BONE MATERIAL FOR BONE HEALING IN JAW BONES |
|
Scientific Title of Study
|
3D printed POLYLACTIC-CO-GLYCOLIC ACID(PLGA)scaffolds for bone regeneration in osseous defects of maxilla and mandible. |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr.Venkata ramana murthy v |
| Designation |
Professor |
| Affiliation |
anil neerukonda isntitute of dental sciences |
| Address |
Room no-3,
Department of Oral and Maxillofacial surgery,
Anil Neerukonda Institute of Dental sciences
39-22-37/1,
KALINGA NAGAR,MADHAVADHARA,
VISAKHAPATNAM.
ANDHRA PRADESH
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9849598601 |
| Fax |
|
| Email |
dr.venkataramanamurthyv@anesehs.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Venkata Ramana Murthy |
| Designation |
Professor |
| Affiliation |
ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES |
| Address |
Room no-3,
Department of oral and maxillofacial surgery,
Anil Neerukonda Institute of Dental sciences
39-22-37/1,
KALINGA NAGAR,MADHAVADHARA,
VISAKHAPATNAM.
ANDHRA PRADESH
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9849598601 |
| Fax |
|
| Email |
Dr.venkataramanamurthyv@anesehs.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr V Venkata Ramana Murthy |
| Designation |
Professor |
| Affiliation |
Anil Neerukonda institute of dental sciences |
| Address |
Room no-3,
Department of Oral and Maxillofacial surgery,
Anil Neerukonda institute of dental sciences
39-22-37/1,Kalinganagar,
mdhavadhara,visakhaptnam
Visakhapatnam
ANDHRA PRADESH
531162
India |
| Phone |
9849598601 |
| Fax |
|
| Email |
dr.venkataramanamurthyv@anesehs.org |
|
|
Source of Monetary or Material Support
|
| ANIL NEERUKONDA INSTITUTE OF DENTAL SCIENCES,sangivalsa,visakhapatnam,pincode -531162 |
| DR NTR UNIVERISTY OF HEALTH SCIENCES,Ramavarappadu,vijayawada,picode-520008 |
|
|
Primary Sponsor
|
| Name |
ANIL NERUKONDA INSTITUTE OF DENTAL SCINCES |
| Address |
SANGIVALSA
ANDHRA PRADESH,
pincode-520008 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| dr vvr murthy |
Anil neerukonda institute of dental sciences |
DOOR NO :39-22-37/1,KALINGA NAGAR
MADHAVADHARA
Visakhapatnam
ANDHRA PRADESH |
08897550544
dr.venkataramanamurthyv@anesehs.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITEE-ANIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K011||Impacted teeth, (2) ICD-10 Condition: M260||Major anomalies of jaw size, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3d printed scaffold application in cystic defects |
enucleated cystic defects will be implanted with 3d printed custom made scaffold . |
| Comparator Agent |
control group without application of scaffold |
cystic defects assessed and enucleated and left for healing, after 4 weeks and 12 weeks for evaluation of the same |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Cystic Defects of the Maxilla and Mandible after cyst enucleation
Primary defects after cyst enucleation less than 4cm |
|
| ExclusionCriteria |
| Details |
Patients with sytemic disease
patients on calcium and vitamin d supplementation |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of PLGA SCAFFOLDS |
assessment of bone formed at 4th week and 12th week with CT evaluation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| assessment of bone density formed at 4th week and 12th by histomorphic analysis |
4th week,12th week. |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [murthymaxfac@gmail.com].
- For how long will this data be available start date provided 01-08-2024 and end date provided 01-06-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
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. |