| CTRI Number |
CTRI/2026/04/108179 [Registered on: 12/04/2026] Trial Registered Prospectively |
| Last Modified On: |
10/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative study of a new cell-based technique versus traditional iliac bone grafting for bone regeneration in cleft alveolus patients |
|
Scientific Title of Study
|
To Evaluate the Efficacy of Bone Marrow Derived Mononuclear Stem Cells Combined with Platelet Rich Plasma Seeded into Allogenic Bone Graft in Alveolar Bone Grafting in cleft patients – A Novel Revolutionary Technique |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Acchuthaubanyashri |
| Designation |
Postgraduate student |
| Affiliation |
Meenakshi Ammal Dental College And Hospital |
| Address |
meenakshi ammal dental college.alapakkam main road
dept of omfs
room no 5
Chennai
TAMIL NADU
600095
India |
| Phone |
09003236916 |
| Fax |
|
| Email |
acchuthadam@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Acchuthaubanyashri |
| Designation |
Postgraduate student |
| Affiliation |
Meenakshi Ammal Dental College And Hospital |
| Address |
meenakshi ammal dental college
dept of omfs
room no 5
Chennai
TAMIL NADU
600095
India |
| Phone |
09003236916 |
| Fax |
|
| Email |
drjayanthishyam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Acchuthaubanyashri |
| Designation |
Postgraduate student |
| Affiliation |
Meenakshi Ammal Dental College And Hospital |
| Address |
meenakshi ammal dental college
dept of omfs
room no 5
Chennai
TAMIL NADU
600095
India |
| Phone |
09003236916 |
| Fax |
|
| Email |
drjayanthishyam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Meenakshi ammal dental college |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
meenkashi ammal dental college |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrAcchuthaubanyashri |
Meenakshi Ammal Dental College And Hospital |
alapakkam main road maduravoyal
Thiruvallur
TAMIL NADU |
09003236916
acchuthadam@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: Q351||Cleft hard palate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Autogenous Iliac Crest Bone Graf |
Patients undergo secondary alveolar bone grafting using conventional autogenous cancellous bone harvested from the anterior iliac crest. The harvested bone is prepared and placed into the alveolar cleft defect following standard surgical procedures. |
| Intervention |
BMMNC + PRP with Allogenic Bone Graft |
Patients undergo secondary alveolar bone grafting using a composite regenerative approach consisting of bone marrow-derived mononuclear cells (BMMNCs), platelet-rich plasma (PRP), and allogenic bone scaffold. Bone marrow aspirate is obtained from the anterior iliac crest and processed intraoperatively to isolate BMMNCs. PRP is prepared from peripheral blood using centrifugation. The concentrated BMMNCs and PRP are combined with particulate allogenic bone graft and placed into the alveolar cleft defect. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Patients born with alveolar defects including cleft lip and palate
Patients age range 5-15years
Non syndromic patients
Non infectious patients
Patients willing to be part of the study |
|
| ExclusionCriteria |
| Details |
Patients who underwent previous SABG procedure
Syndromic patient
Patients with uncontrolled systemic diseases
Immunocompromised or immune suppressed patients
Patients with Cardiac abnormalities Hematologic diseases Paget’s disease Osteopetrosis Rickets Any other Bony pathological conditions neoplastic condition Chemotherapy |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
to measure the volume of the newly formed bone
to assess the bone density of newly formed bone |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
PAIN
GAIT
|
5TH DAY - PAIN
1 MONTH - GAIT |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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
|
N/A |
|
Date of First Enrollment (India)
|
30/04/2026 |
| 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="2"
Months="0"
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 - Statistical Analysis Plan
Response - Informed Consent Form
- 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 - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [acchuthadam@gmail.com].
- For how long will this data be available start date provided 28-03-2026 and end date provided 30-04-2026?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
The aim of this study is to assess the bone regenerative ability of autologous bone marrow derived mononuclear stem cells in combination with Platelet Rich Plasma seeded into allogenic bone graft in Alveolar bone grafting HYPOTHESIS - Autologous Bonoemarrow mononuclear stem cells in combination with platelet rich plasma seeded into Allogenic bone graft acts as osteogenic graft in promoting superior bone regeneration in alveolar bone grafting and this technique can be considered as an alternative for iliac bone harvesting |