| CTRI Number |
CTRI/2024/07/071118 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
24/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Invitro study |
| Study Design |
Other |
|
Public Title of Study
|
An in vitro investigation to assess the osteoanabolic effects of doxycycline in a proteosomal gel form. |
|
Scientific Title of Study
|
Evaluation of Osteoanabolic effect of Doxycycline Proniosomal gel form : An invitro study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vaishnavi Langde |
| Designation |
PostGraduate student |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
104,Department of Periodontics Ranjeet Deshmukh Dental College and Research Centre Nagpur
Nagpur MAHARASHTRA 440019
India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
9158479776 |
| Fax |
|
| Email |
tikhevaishnavi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhawal Mody |
| Designation |
Professor and guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
104,Department of Periodontics Ranjeet Deshmukh Dental College and Research Centre Nagpur
Nagpur MAHARASHTRA 440019
India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
8055775977 |
| Fax |
|
| Email |
periowell@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhawal Mody |
| Designation |
Professor and guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
104,Department of Periodontics Ranjeet Deshmukh Dental College and Research Centre Nagpur
Nagpur MAHARASHTRA 440019
India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
8055775977 |
| Fax |
|
| Email |
periowell@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self, Ranjeet Deshmukh Dental College and Research Centre, Nagpur-440019 |
|
|
Primary Sponsor
|
| Name |
Dr Vaishnavi Langde self |
| Address |
Ranjeet Deshmukh Dental College and Research Centre,
Digdoh Hills, Hingna Road,
Nagpur – 440019
|
| Type of Sponsor |
Other [Dr Vaishnavi Langde (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 |
| Dr Vaishnavi Langde |
Regenerative Medicine Laboratory |
Dr DY Patil Dental College & Hospital Sant Tukaram Nagar Pimpri Pune Maharashtra 411018 Pune MAHARASHTRA
Nagpur
MAHARASHTRA |
9158479776
tikhevaishnavi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ranjeet Deshmukh Dental College and Research Center |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy dental pulp mesenchymal stem cells procured from healthy non carious extracted tooth. |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Healthy dental pulp mesenchymal stem cells procured from healthy non carious extracted tooth. |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Invitro evaluation of the biological behavior of doxycycline proniosomal gel for their use as bone regenerative material. |
1,2and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To evaluate the cytotoxic effect of doxycycline proniosomal gel on pulpal dental stem cells by MTT assay.
2. To study the osteogenic differentiation potential of doxycycline proniosomal gel in mesenchymal stem cells by alizarin red staining.
3. To investigate the osteogenic gene expression such as alkaline phosphatase and osteonectin for osteogenic differentiation.
|
1,2 and 6 months |
|
|
Target Sample Size
|
Total Sample Size="2"
Sample Size from India="2"
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)
|
19/08/2024 |
| 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="0"
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 - NO
|
|
Brief Summary
|
Evaluation of Osteoanabolic effect of Doxycycline Proniosomal gel form
: An invitro study.Objectives: 1.Invitro evaluation
of the biological behavior of doxycycline proniosomal gel for their use as bone
regenerative material. 2. To evaluate the cytotoxic effect of
doxycycline proniosomal gel on pulpal dental stem cells by MTT assay.
3.
To study the osteogenic
differentiation potential of doxycycline proniosomal gel in mesenchymal stem
cells by alizarin red staining.
4.
To
investigate the osteogenic gene expression such as alkaline phosphatase and
osteonectin for osteogenic differentiation. |