| CTRI Number |
CTRI/2025/04/083963 [Registered on: 03/04/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
TREATMENT OF PERIODONTAL Intra bony defects by using TPRF and 1% METFORMIN gel.
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Scientific Title of Study
|
A comparative evaluation of TITANIUM PLATELET RICH FIBRIN alone and in combination with 1% METFORMIN GEL in the treatment of intra bony defects; A split- mouth study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR MANIKANTA JAJAM |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
DR. N.T.R UNIVERSITY OF HEALTH SCIENCES |
| Address |
DEPARTMENT OF PERIODONTICS SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE 7 27 23 VIJAYA TALKIES ROAD GHANDI BAZAR MARKAPUR 523316 Srikakulam ANDHRA PRADESH 532001 India |
| Phone |
8886712823 |
| Fax |
|
| Email |
jajammani22@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
K. ANIL KUMAR |
| Designation |
PROFESSER AND HEAD OF THE DEPARTMENT |
| Affiliation |
DR. N.T.R UNIVERSITY OF HEALTH SCIENCES |
| Address |
DEPARTMENT OF PERIODONTICS SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE CHAPURAM SREE SAI DENTAL COLLEGE AND REASEARCH INSTITUTE Srikakulam ANDHRA PRADESH 532001 India |
| Phone |
9989570600 |
| Fax |
|
| Email |
anilkanc@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
MANI KANTA JAJAM |
| Designation |
POSTGRADUATE STUDENT |
| Affiliation |
DR. N.T.R UNIVERSITY OF HEALTH SCIENCES |
| Address |
DEPARTMENT OF PERIODONTICS SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE CHAPURAM 7 27 23 VIJAYA TALKIES ROAD GHANDI BAZAR MARKAPUR 523316 Srikakulam ANDHRA PRADESH 532001 India |
| Phone |
8886712823 |
| Fax |
|
| Email |
jajammani22@gmail.com |
|
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Source of Monetary or Material Support
|
| DOOR NUMBER 6 2 15 Chapuram National highway Palasa to Srikakulam Peda Padu Road Srikakulam 532001 |
|
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Primary Sponsor
|
| Name |
Dr J MANIKANTA |
| Address |
SECOND YEAR POST GRADUATE DEPARTMENT OF PERIODONTICS SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTION SRIKAKULAM 532401 |
| Type of Sponsor |
Other [] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr J Manikanta |
sree sai dental college |
Room no-8 D.No: 6-2-15 , Chinnabazar , Chapuram,
Srikakulam
Srikakulam Dist.
Pincode: 532 001 Srikakulam ANDHRA PRADESH |
08886712823
jajammani22@gmail.com |
| Dr J Manikanta |
sree sai dental college |
Room no - 8, D.No: 6-2-15 , Chinnabazar , Chapuram,
Srikakulam
Srikakulam Dist.
Pincode: 532 001 Srikakulam ANDHRA PRADESH |
08886712823
jajammani22@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SREE SAI DENTAL COLLEGE AND RESEARCH INSTITUTE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Patients with periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
open flap debridement and metformin gel |
The patient is treated with open flap debridement 1 percent metformin gel as a control a 6 month study |
| Intervention |
T-prf + metformin gel |
patient is treated with open flap debridement 1 percent metformin gel along with Titanium prf a 6 month study |
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria
1) Age 25 to 55 years
2) systematically healthy Patients with periodontitis​
3) ​ Presence of Intra bony defect greater than 3mm
4) Minimum of 2 teeth with probing pocket depth greater than 5 mm on either side of the same arch
5) Clinical attachment loss greater than 4mm ​
6) Depiction of angular defects in the intraoral periapical radiograph​
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria
1) Patients with aggressive periodontitis​
2) systemic diseases​
3) patients who had no active periodontal therapy and drug history in the past 6 months
4) Smokers​
5) Pregnant and lactating women were excluded from the study
6) Mobile nonvital ​poor prognosed teeth
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
primary outcome : decreased pocket depth, reduced CAL , bone fill
secondary outcome: plaque index, gingival index, bleeding index |
baseline and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| plaque index, gingival index, bleeding index. |
base line and 6 months |
| decreased pocket depth, reduced CAL , bone fill |
baseline to 6 months |
|
|
Target Sample Size
|
Total Sample Size="12" Sample Size from India="12"
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)
|
28/07/2025 |
| 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="7" 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
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Brief Summary
|
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The split mouth study will consist of 12 systemically healthy patients visiting the Department of Periodontics. An informed consent will be
obtained from the patients. Initially scaling and root planning will be done under local anesthesia
followed by oral hygiene instruction. The patient will be recalled for
periodontal surgery. The following clinical and radiographic parameters
will be recorded at baseline, 6 months Stent fabrication Two acrylic stents for each site were prepared and
checked for proper stability one for CAL and the other for measuring the
depth of interproximal bony defects during the surgical procedures PRF-T rpm Just before the surgery, intravenous blood was
collected in a 10 ml sterile titanium test tube without anticoagulant by vein
puncturing of the antecubital vein The tubes were
immediately centrifuged at 3000 rpm for 10 minutes in a centrifuge machine
(C-852, REMI, Mumbai, INDIA). Blood centrifugation immediately after collection
allows the composition of a structured fibrin clot in the middle of the tube,
just between the red corpuscles at the bottom and acellular plasma (Platelet
Poor Plasma (PPP)) at the top TPRF clot thus
formed was separated using sterile tweezers and scissors and transferred onto
PRF box and a stable fibrin membrane was obtained by squeezing serum out of
the T-PRF clot 1%Metformin gel are formulated from
perioBiologics LLP laboratory Hydereabad.
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