| CTRI Number |
CTRI/2025/03/082640 [Registered on: 18/03/2025] Trial Registered Prospectively |
| Last Modified On: |
08/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Platelet application to gums to treat gum diseases |
|
Scientific Title of Study
|
Clinical efficacy of subgingival application of injectable platelet rich fibrin as an adjuntive therapy to scaling and root planing - A split mouth randomized clinical trial |
| 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 V VAISHNAVI |
| Designation |
POST GRADUATE STUDENT DEPARTMENT OF PERIODONTICS |
| Affiliation |
SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL |
| Address |
ROOM NUMBER 5, DEPARTMENT OF PERIODONTICS, SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL, VIDYANAGAR HASSAN
DEPARTMENT OF PERIODONTICS, SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL, VIDYANAGAR HASSAN
Hassan
KARNATAKA
573202
India |
| Phone |
9945565263 |
| Fax |
|
| Email |
drvaishnavi8298@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR VIVEKANANDA M R |
| Designation |
PROFESSOR, DEPT OF PERIODONTICS SRI HASANAMABA DENTAL COLLEGE |
| Affiliation |
Sri Hasanamba Dental College and Hospital |
| Address |
Room Number 5, Department of Periodontics, Sri Hasanamba Dental College and Hospital, Vidyanagar Hassan
Room Number 5, Department of Periodontics, Sri Hasanamba Dental College and Hospital, Vidyanagar Hassan
Hassan
KARNATAKA
573202
India |
| Phone |
9980843531 |
| Fax |
|
| Email |
vivekcodsperio@ymail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR V VAISHNAVI |
| Designation |
POST GRADUATE STUDENT DEPARTMENT OF PERIODONTICS |
| Affiliation |
SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL |
| Address |
ROOM NUMBER 5, DEPARTMENT OF PERIODONTICS, SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL, VIDYANAGAR HASSAN
DEPARTMENT OF PERIODONTICS, SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL, VIDYANAGAR HASSAN
Hassan
KARNATAKA
573202
India |
| Phone |
9945565263 |
| Fax |
|
| Email |
drvaishnavi8298@gmail.com |
|
|
Source of Monetary or Material Support
|
| ROOM NUMBER 5, DEPARTMENT OF PERIODONTICS, SRI HASANAMBA DENTAL COLLEGE AND HOSPITAL, VIDYANAGAR HASSAN KARNATAKA 573202 INDIA |
|
|
Primary Sponsor
|
| Name |
Sri Hasanamba Dental College and Hospital |
| Address |
Vidyanagar Hassan Karnataka 573202 |
| 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 |
| DR V VAISHNAVI |
Sri Hasanamba Dental College and Hospital |
Room Number 5, Department of Periodontics, Sri Hasanamba Dental College and Hospital, Vidyanagar Hassan
Hassan
KARNATAKA |
09945565263
drvaishnavi8298@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committe (R), Sri Hasanamba Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
injectable platelet rich fibrin |
IPRF applied subgingivally after scaling and root planing- Locally applied into the periodontal pocket and patient will be recalled after 14days,1month and 3months for follow up |
| Comparator Agent |
Scaling and root planing
|
scaling and root planing is the gold standard treatment for the management of chronic periodontitis and patient will be recalled after 14days,1month and 3months for follow up |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. willingness to comply with study protocol
2. subjects diagnosed with chronic generalised periodontis
3. subjects should have mild to moderate periodontal pockets
4. subjects age group 25-55years |
|
| ExclusionCriteria |
| Details |
1.Subjects suffering from any known systemic diseases.
2.Subjects who had received any antibiotic therapy in the last 6 months.
3.Pregnant and lactating women.
4.Subjects who are smokers.
5.Subjects who had received any chemotherapeutic mouth rinses or oral irrigation or using any other oral care products during the past 3 months.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of clinical signs, Gingival index, Papillary bleeding index, Probing pocket depth, Clinical attachment level |
Reduction of clinical signs, Gingival index, Papillary bleeding index, Probing pocket depth, Clinical attachment level will be assessed at baseline,14th day,1month,3month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction of clinical signs, Gingival index, Papillary bleeding index, Clinical attachment level |
3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
24/03/2025 |
| 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="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 - NO
|
|
Brief Summary
|
Platelet concentrates have been used to enhance the regenerative potential for a number of reasons. Firstly, they contain various growth factors such as platelet derived growth factor, transforming growth factor, vascular endothelial growth factor, epidermal growth factor, and insulin like growth factor 1 in the granules of platelets. Secondly, these factors are released at the local site on their activation and impart antiinflammatory properties. Taking these points into consideration, subgingival application of I PRF along with initial periodontal therapy may provide more effective improvements in clinical parameters due to the presence of multiple growth factors and leukocytes. |