| CTRI Number |
CTRI/2025/11/096955 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
05/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
observational |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to compare the tooth forming ability of stem cells in 2D and 3D culture system |
|
Scientific Title of Study
|
Comparative analysis of Odonto/Osteogenic Potential of human gingival mesenchymal stem cells in 2D and 3D culture systems
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Srilakshmi |
| Designation |
Post Graduate |
| Affiliation |
NITTE (Deemed to be University) |
| Address |
A B Shetty Memorial Institute of Dental Sciences NITTE (Deemed to be University)
Department of periodontology, 4th floor, Derlakkatte , Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9633935681 |
| Fax |
|
| Email |
m.sreelakshmi200@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mamatha Shekar Shetty |
| Designation |
Professor |
| Affiliation |
NITTE (Deemed to be University) |
| Address |
A B Shetty Memorial Institute of Dental Sciences NITTE (Deemed to be University)
Department of periodontology, 4th floor, Derlakkatte , Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9886756440 |
| Fax |
|
| Email |
drmamathasshetty@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Srilakshmi |
| Designation |
Post Graduate |
| Affiliation |
NITTE (Deemed to be University) |
| Address |
A B Shetty Memorial Institute of Dental Sciences NITTE (Deemed to be University)
Department of periodontology, 4th floor, Derlakkatte , Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9633935681 |
| Fax |
|
| Email |
m.sreelakshmi200@gmail.com |
|
|
Source of Monetary or Material Support
|
| A B Shetty Memorial institute of Dental Sciences
K S Hegde Medical college Stem cell research centre |
|
|
Primary Sponsor
|
| Name |
A B Shetty Memorial Institute of Dental sciences |
| Address |
Derlakkatte
Mangalore
Pin code:575018 |
| Type of Sponsor |
Other [Institution] |
|
|
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 Srilakshmi |
AB Shetty Memorial Institute of Dental Sciences |
Department of Periodontics,AB Shetty Memorial Institute of Dental sciences,Mangalore
Dakshina Kannada
KARNATAKA |
9633935681
m.sreelakshmi200@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 |
| Healthy Human Volunteers |
Human gingival tissue samples obtained from patients undergoing routine dental procedure , for in-vitro evaluation of mesenchymal stem cell differentiation potential |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Systemically healthy patients with a minimum complement of 20 natural teeth undergoing extraction of premolars for orthodontic treatment.
2.Patients with good oral hygiene (Plaque index less than 1).
3.Periodontally healthy patients (less than 1 Gingival index score, less than 3 mm PD and CAL less than 2 mm).
4.Age group between 18 and 30 years.
|
|
| ExclusionCriteria |
| Details |
1.Patients with history of any systemic disease.
2.Patients on antibiotic therapy of any form for the last 6 months.
3.Presence of any periodontal disease.
4.History of any form of tobacco usage.
5.Pregnant or lactating women.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The present study compares odontogenic and osteogenic differentiation potential of human gingival mesenchymal stem cells when cultured under 2d and 3d culture systems.
The finding of this study will contribute to better understanding of regenerative potential of gingival stem cells and aid in developing scaffold based strategies for periodontal regeneration |
4 weeks to 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="5"
Sample Size from India="5"
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)
|
27/11/2025 |
| 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="10" |
|
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 - NO
|
|
Brief Summary
|
Periodontitis is a chronic inflammatory condition leading to
destruction of tooth-supporting tissues and eventual tooth loss. Regenerative
therapy aims to restore lost periodontal structures, and stem cell–based
approaches have gained prominence due to their self-renewal and multilineage
differentiation potential. Among dental stem cells, human gingival mesenchymal
stem cells are easily accessible, highly proliferative, and exhibit
strong osteogenic potential.
The present study aims to compare the odonto-osteogenic
differentiation potential of GMSCs cultured under two-dimensional 2D and
three-dimensional 3D systems. Healthy gingival tissues will be collected from
patients undergoing routine dental procedures. Isolated GMSCs will be
characterized for MSC surface markers CD73, CD90, CD105 and induced toward
osteogenic differentiation under both 2D and 3D conditions. The 3D cultures
will be established using the hanging drop spheroid method.
Comparative evaluation will be performed through
morphological assessment, cytochemical staining ALP, Alizarin Red S, and
molecular analysis of osteogenic markers by RT-PCR. It
is hypothesized that 3D-cultured GMSCs will demonstrate enhanced osteogenic
differentiation due to improved cell–cell and cell–matrix interactions that
better mimic in vivo conditions.
The study is expected to provide valuable insight into
optimizing culture conditions for GMSC-based regenerative applications in
periodontal and alveolar bone tissue engineering
|