| CTRI Number |
CTRI/2025/11/097369 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
11/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
" Study to see if a special blood product(T-PRF) helps to improve gum health after deep cleaning for gum disease patient" |
|
Scientific Title of Study
|
Titanium-Prepared Platelet Rich Fibrin on Non-Surgical Periodontal Therapy: A Split-Mouth Randomized Controlled 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 Subash mehta |
| Designation |
Junior Resident |
| Affiliation |
Aiims, Rishikesh |
| Address |
Aiims ,Rishikesh , Department of dentistry (Periodontics) Room no.117
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7295934977 |
| Fax |
|
| Email |
subashmeh95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashutosh Dixit |
| Designation |
Additional Professor |
| Affiliation |
Aiims, Rishikesh |
| Address |
Department of dentistry,Aiims,Rishikesh, Uttrakhand, India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9899818242 |
| Fax |
|
| Email |
dixitdrashutosh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashutosh Dixit |
| Designation |
Additional Professor |
| Affiliation |
Aiims, Rishikesh |
| Address |
Department of dentistry,Aiims,Rishikesh, Uttrakhand, India
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9899818242 |
| Fax |
|
| Email |
dixitdrashutosh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aiims , Rishikesh ,uttranchal , India, pin code-249203 |
|
|
Primary Sponsor
|
| Name |
Dr Subash Mehta |
| Address |
Aiims, Rishikesh, Uttranchal, India, pin code-249203 |
| 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 Subash Mehta |
AIIMS Hospital, Rishikesh |
Department of Dentistry, Division-Periodontics, room no-117
Dehradun
UTTARANCHAL |
07295934977
subashmeh95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Commitee AIIMS, Rishikesh,uttrakhand ,india |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
periodontal disease involving teeth and gums |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
scaling and root planing (SRP) |
scaling and root planing will only be done, and result will be seen in 6 weeks. No addition of autologous blood product in this group |
| Intervention |
Titanium prepared platelet rich fibrin (T-PRF) placed in periodontal pocket and result will be seen after 6 weeks |
After performing scaling and root planing (SRP), T-PRF will be prepared from the patients blood and will be placed in periodontal pocket and result will be seen after 6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Following patient will be included
1.Systemically healthy or with well-controlled systemic conditions (Diabetes Mellitus, Hypertension, Chronic kidney disease, cardiovascular disease)
2.With periodontitis Stage III Grade A (diagnosed according to the Classification of Periodontal and Peri-Implant Diseases and Conditions 2017)
3.With a 5 – 6 mm probing depth.
4.Patient willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Following patients will be excluded
1.History of systemic disease (Diabetes mellitus,Hypertension, Chronic kidney disease, cardiovascular disease)
2. Presence of active gingival disease
3.Pregnancy and lactation
4.History of any drug or systemic antibiotic usage affecting the periodontium for the past 3 months
5. History of periodontal surgery within the preceding six months
6.Current smokers
7.Teeth with untreated caries
8. Endodontic periapical lesions
9. Grade II or III mobility.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction in probing pocket depth (PPD) |
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Clinical attachment level (CAL)gain.
2.Reduction in Plaque Index score
3.Reduction in Gingival Index score
4.Increase in Wound Healing Index sccore
5.Reduction in bleeding on probing (BOP) |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
24/11/2025 |
| 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="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
|
This split-mouth randomized controlled clinical trial aims to assess the adjunctive role of titanium-prepared platelet-rich fibrin (t-PRF) on non-surgical periodontal therapy (scaling and root planing, SRP) in patients with chronic periodontitis. Systemically healthy patient of age between 18-55 years diagnosed with Periodontitis Stage III Grade A will be included. Patients with contralateral periodontal sites exhibiting similar probing pocket depths (5-6 mm) will receive scaling and root planing (SRP) in all affected areas. Following SRP, test sites will be treated with t-PRF membranes prepared from the patient’s own blood using titanium tubes, while in control sites no additional treatment will be given. Clinical outcomes, including probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), and bleeding on probing (BOP), will be recorded at baseline and at 6 weeks post-treatment. The allocation of test and control sites will be randomized, and the clinical examiner will be blinded. Statistical analyses will compare the clinical improvements between the two groups, with the expectation that t-PRF will enhance healing and improve periodontal parameters more effectively than scaling and root planing alone. |