| CTRI Number |
CTRI/2024/12/078041 [Registered on: 12/12/2024] Trial Registered Prospectively |
| Last Modified On: |
28/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Surgical/Anesthesia
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
VOLUMETRIC ANALYSIS OF BONE FORMATION FOLLOWING JAW BONE CYST SURGICAL REMOVAL AND PLACEMENT OF PRF IN DEFECT AND POST OPERATIVE FOLLOW-UP USING COMPUTED TOMOGRAPHY |
|
Scientific Title of Study
|
VOLUMETRIC ANALYSIS OF BONE FORMATION FOLLOWING BENIGN JAW CYST ENUCLEATION WITH PLACEMENT OF PRF USING COMPUTED TOMOGRAPHY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vemuluri Siri |
| Designation |
Postgraduate student |
| Affiliation |
Thai moogambigai dental collage and hospital |
| Address |
Dr.M.G.R Educational and Research Institute,Thai Moogambigai Dental College and Hospital, Branch No.03 Department of Oral and Maxillofacial Surgery, ,Golden George nagar ,Mugappair ,Chennai.
Thiruvallur
TAMIL NADU
600107
India |
| Phone |
9121793214 |
| Fax |
|
| Email |
drsirisurgery@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K Senthil Kumar |
| Designation |
Professor |
| Affiliation |
Thai moogambigai dental collage and hospital |
| Address |
Dr.M.G.R Educational and Research Institute Thai Moogambigai Dental College and Hospital, Department of Oral and Maxillofacial Surgery ,Golden George nagar ,Mugappair ,Chennai.
Thiruvallur
TAMIL NADU
600107
India |
| Phone |
09884634754 |
| Fax |
|
| Email |
senthilomfs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K Senthil Kumar |
| Designation |
Professor |
| Affiliation |
Thai moogambigai dental collage and hospital |
| Address |
Dr.M.G.R Educational and Research Institute Thai Moogambigai Dental College and Hospital, Department of Oral and Maxillofacial Surgery ,Golden George nagar ,Mugappair ,Chennai.
Thiruvallur
TAMIL NADU
600107
India |
| Phone |
09884634754 |
| Fax |
|
| Email |
senthilomfs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.M.G.R Educational and Research Institute,Thai Moogambigai dental collage and hospital, branch no 03, department of oral and maxillofacial surgery, Golden Geroge Nagar, Mugappair, Chennai-600107 |
|
|
Primary Sponsor
|
| Name |
vemuluri siri |
| Address |
Dr.M.G.R Educational and research institute, Thai Moogambigai dental collage and hospital, branch no 03, department of oral and maxillofacial surgery, Golden Geroge Nagar, Mugappair, Chennai-600107 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| DrVemuluri Siri |
Thai moogambigai dental college and hospital |
Branch 03,Department of Oral and Maxillofacial Surgery ,Golden George nagar ,Mugappair ,Chennai
600107
thiruvallur.
Thiruvallur
TAMIL NADU |
09884634754
drsirisurgery@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K099||Cyst of oral region, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
platelet rich fibrin |
Patients venous blood drawn and centrifuged for 18 minutes at 3000 rpm to make the platelet rich fibrin. Cyst enucleation and chemical cauterization done and placement of platelet rich fibrin in the bony defect and closed. Follow up and Assessment for 3 and 6 months for post operative bone formation using computed tomography. Hounsfield units are checked as an indicator for healing process. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Benign jaw cyst.
Patients belonging to ASA I;a normal healthy patient and ASA II;a patient with mild systemic disease.
Patients that agreed to present for follow-up visits
|
|
| ExclusionCriteria |
| Details |
Medically compromised patients.
Patients with bone diseases. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the bone formation after placement of platelet rich fibrin over the bony defect of cystic cavity post enucleation |
Follow up and Assessment for 3 and 6 months, for post operative bone formation using computed tomography. Hounsfield units are checked as an indicator for healing process. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess healing of the cystic bony defect area with bone formation |
Follow up & Assessment for 3 & 6 months for post operative bone formation using computed tomography. Hounsfield units are checked as an indicator for healing process. |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| Date of Study Completion (India) |
01/04/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
To study the efficacy of bone healing in the treatment of benign jaw cystic lesions post enucleation. This systematic review focuses on the bone regeneration rate after PRF placement in the treatment of jaw cystic lesion The lesion undergoes progressive resolution and bone regeneration of the cystic cavity within a short period of time, The use of PRF can result in healing with faster favourable bone regeneration and closure of bony defect and use of PRF is safe, effective and easily available.
|