| CTRI Number |
CTRI/2026/03/106271 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
14/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare two surgical treatments for deep gum-related bone loss—one using the patient’s own platelet-rich fibrin (i-PRF) with bonegraft and other using bonegraft alone. |
|
Scientific Title of Study
|
Efficacy of injectable platelet rich fibrin with xenograft compared to xenograft alone in the treatment of two or three wall intrabony defect in patients with stage 3 periodontitis a randomized controlled study |
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ANAGHA T |
| Designation |
Post graduate student |
| Affiliation |
Goverment dental college Thiruvananthapuram |
| Address |
Department of periodontics Room no A -204 Goverment dental college Medical college road Chalakkuzhi Thiruvananthapuram Kerala 695011
Thiruvananthapuram KERALA 695011 India |
| Phone |
07025618919 |
| Fax |
|
| Email |
anaghatp96@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Bindu R Nayar |
| Designation |
Head of department and guide |
| Affiliation |
Goverment dental college Thiruvananthapuram |
| Address |
Department of periodontics Room no A -205 Goverment dental college Medical college road Chalakkuzhi Thiruvananthapuram Kerala 695011
Thiruvananthapuram KERALA 695011 India |
| Phone |
9847237090 |
| Fax |
|
| Email |
brn09sai@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Bindu R Nayar |
| Designation |
Head of department and guide |
| Affiliation |
Goverment dental college Thiruvananthapuram |
| Address |
Department of periodontics Room no A -205 Goverment dental college Medical college road ChalakkuzhiThiruvananthapuram Kerala 695011
Thiruvananthapuram KERALA 695011 India |
| Phone |
9847237090 |
| Fax |
|
| Email |
brn09sai@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goverment dental college Medical college road Chalakkuzhi Thiruvananthapuram Kerala 695011 |
|
|
Primary Sponsor
|
| Name |
Dr Anagha T |
| Address |
Department of periodontics.Room no A204.Goverment dental college Thiruvananthapuram.Kerala .695011 |
| 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 Anagha T |
Goverment dental college Thiruvananthapuram |
Department of Periodontics ,Room No 204 ,medical college road ,Chalakkuzhi.695011 Thiruvananthapuram KERALA |
7025618919
anaghatp96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee.Goverment dental college thiruvananthapuram |
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 |
management with i prf and xenograft. |
Treatment of 2 or 3 wall intrabony defect with iprf and xenograft |
| Comparator Agent |
management with xenograft only |
Treatment of 2 or 3 wall intrabony defect with xenograft alone. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 18 years and above who is willing to participate .
2. Patient diagnosed with stage III periodontitis with clinical attachment level greater than or equal to 5mm and probing
Depth greater than or equal to 6mm
3. Two or three walled intra bony defect measuring greater than or equal to 3mm radiographically using RVG |
|
| ExclusionCriteria |
| Details |
1. Uncontrolled systemic diseases.
2. History of periodontal surgery in the site within 6 months.
3. Current smoker or using tobacco related product.
4. Pregnant and lactating mother.
5. Patients on medications affecting bone metabolism |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical attachment level in mm |
Base line ,4 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Periodontal probing depth in mm
|
Base line ,4 Month |
| Gingival recession in mm |
Base line ,4 month |
| Linear bone growth in mm |
Base line ,4 month |
| Patient satisfaction assessed using VAS Score |
4 Month |
|
|
Target Sample Size
|
Total Sample Size="42" Sample Size from India="42"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
10/04/2026 |
| 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 study titled “Efficacy of Injectable Platelet Rich Fibrin (I-PRF) with Xenograft Compared to Xenograft Alone in the Treatment of Two or Three-Wall Intrabony Defects in Stage III Periodontitis – A Randomized Controlled Trial” is being conducted at the Government Dental College. The study aims to evaluate whether the addition of injectable platelet-rich fibrin (I-PRF) to xenograft provides superior clinical and radiographic outcomes compared to xenograft alone in patients diagnosed with Stage III periodontitis presenting with two- or three-wall intrabony defects. A total of 42 patients will be recruited and randomly allocated into two groups: Group A will receive xenograft combined with I-PRF, while Group B will receive xenograft alone. All participants will undergo initial phase I therapy followed by open flap debridement and placement of the respective graft material. The primary outcome measure is change in Clinical Attachment Level (CAL) at 4 months, assessed using a UNC-15 probe. Secondary outcomes include probing pocket depth, gingival recession, linear bone growth assessed radiographically using RVG, and patient satisfaction measured with VAS score. This two-arm, parallel, open-label randomized controlled trial will have follow-ups at 1 and 4 months. Data will be statistically analyzed using appropriate tests with significance set at p < 0.05. Ethical approval will be obtained from the Institutional Ethics Committee. |