| CTRI Number |
CTRI/2025/08/092785 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [NATURAL GELS] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparision of mangosteen and moringa oliefera gel with DFDBA individually in participants with intrabony defects |
|
Scientific Title of Study
|
Comparison of Mangosteen gel and Moringa oliefera gel with Demineralised freeze dried bone allograft in the treatment of intrabony defects |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K Sri Divya |
| Designation |
Student |
| Affiliation |
St.Joseph dental college |
| Address |
Department of Periodontics, St.Joseph dental college, Duggirala, Eluru.
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
7981048039 |
| Fax |
|
| Email |
kodamati.sridivya@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
P Aravind kumar |
| Designation |
Professor and HOD |
| Affiliation |
st.joseph dental college |
| Address |
Department of periodontics, St. Joseph dental college,
Duggirala, Eluru.
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
9948544799 |
| Fax |
|
| Email |
pavuluriak@gamil.com |
|
Details of Contact Person
Public Query
|
| Name |
P. Aravind kumar |
| Designation |
Professor and HOD |
| Affiliation |
st.joseph dental college |
| Address |
Department of periodontics, St.Joseph dental college,
Duggirala, Eluru.
West Godavari
ANDHRA PRADESH
534003
India |
| Phone |
9948544799 |
| Fax |
|
| Email |
pavuluriak@gamil.com |
|
|
Source of Monetary or Material Support
|
| St.Joseph dental college, Duggirala, Eluru.
Pincode:534003 |
|
|
Primary Sponsor
|
| Name |
K Sri divya |
| Address |
St.Joseph dental college,
Duggirala, Eluru
Pincode:534003 |
| 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 |
| Dr Sri Divya |
St.Joseph dental college |
Room no:8 Department of periodontics, Duggirala, Eluru.
West Godavari
ANDHRA PRADESH |
7981048039
kodamati.sridivya@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee,St.Joseph dental college,duggirala,eluru,west godavari,andhrapradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
mangosteen gel with DFDBA |
6 to 7 months |
| Comparator Agent |
Moringa oliefera gel with DFDBA |
6 to 7 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Patient having periodontal pocket depth of greater than or equal to 5mm.
2) Clinical attachment loss of greater than or equal to 3mm.
3) Radiographic evidence of intrabony defects |
|
| ExclusionCriteria |
| Details |
1)Those who had undergone any type of regenerative periodontal therapy, bisphosphonate or anti-resorptive drug therapy 6 months prior to the initial examination.
2)Patients with any systemic illness.
3)Patients who are pregnant or lactating, allergic to materials and drugs used or prescribed in this study.
4)History of smoking and alcohol.
|
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the new bone formation ,bone volume, density and height in intrabony defects. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| reduction in pocket depth and clinical attachment loss and bleeding on probing |
6 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
21/08/2025 |
| 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="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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kodamati.sridivya@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
1.
To compare the effectiveness of mangosteen gel and
moringa oleifera gel along with demineralized freeze dried bone allograft in
the treatment of intra bony defects.
2. To assess the
bone formation using cone-beam computed tomography. |