| CTRI Number |
CTRI/2026/02/104065 [Registered on: 17/02/2026] Trial Registered Prospectively |
| Last Modified On: |
16/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of adding platelet rich fibrin during gum papilla reconstruction in patients with black triangles between teeth |
|
Scientific Title of Study
|
Comparative evaluation of Papilla Reconstruction using Incision and Submucosal Mobilization (PRISM) with and without Platelet Rich Fibrin as an adjunct : A Randomized controlled 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 Yathish M |
| Designation |
Postgraduate student |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room no 11 Department of Periodontology
KVG Dental College and Hospital
kurunjibhag sullia dakshina kannada 574239
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9738775679 |
| Fax |
|
| Email |
yatiyathish075@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivananda H |
| Designation |
Associate Professor |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room no 11 Department of Periodontology
KVG Dental College and Hospital
kurunjibhag sullia dakshina kannada 574239
Dakshina Kannada
KARNATAKA
574239
India |
| Phone |
9900794769 |
| Fax |
|
| Email |
shivanand_perio@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivananda H |
| Designation |
Associate Professor |
| Affiliation |
KVG Dental College and Hospital |
| Address |
Room no 11 Department of Periodontology
KVG Dental College and Hospital
kurunjibhag sullia dakshina kannada 574239
Dakshina Kannada
KARNATAKA
574239
India |
| Phone |
9900794769 |
| Fax |
|
| Email |
shivanand_perio@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Yathish M |
| Address |
Room no 11 Department of Periodontology
KVG Dental College and Hospital
kurunjibhag sullia dakshina kannada 574239 |
| 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 Yathish M |
KVG dental college and hospital |
Room no 11 Department of Periodontology
KVG Dental College and Hospital
kurunjibhag sullia dakshina kannada 574239
Dakshina Kannada
KARNATAKA |
9738775679
yatiyathish075@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee K.V.G.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 |
papilla reconstruction |
Papilla reconstruction will be performed using the Papilla Reconstruction using Incision and Submucosal Mobilization (PRISM) technique with placement of autologous Platelet Rich Fibrin membrane as an adjunct to enhance soft tissue healing and papilla fill. |
| Comparator Agent |
papilla reconstruction |
Papilla reconstruction will be performed using the Papilla Reconstruction using Incision and Submucosal Mobilization (PRISM) technique without the use of Platelet Rich Fibrin. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Apparently healthy patient
Patient age ranging 20to35years.
Good oral hygiene (plaque score 0)
Periodontal pocket less than or equal to 4mm.
No radiographic evidence of interdental bone loss.
The respective teeth should be free from caries with no fixed prosthesis or orthodontic appliances.
Participants who will provide informed consent will be included in the study
|
|
| ExclusionCriteria |
| Details |
Pregnancy and lactating mothers
Tobacco users and alcoholic
Patients with uncontrolled systemic conditions/disease
Fixed restoration on study teeth
Tooth mobility
Consumption of drugs causing gingival hyperplasia.
Interdental bone loss
Inadequate attached gingiva on study teeth
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the clinical efficacy of papilla reconstruction using incision and submucosal mobilization ( PRISM) with and without platelet rich fibrin (PRF) |
Baseline
1 week
1 month
3 months
6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess the gain in interdental papilla fill achieved with the PRISM technique with platelet rich fibrin
To assess the gain in interdental papilla fill achieved with the PRISM technique without platelet rich fibrin
To compare the gain in interdental papilla fill achieved with PRISM technique with and without Platelet rich fibrin
To determine the reduction in interdental black triangle height and width in PRISM technique with platelet rich fibrin.
To determine the reduction in interdental black triangle height and width in PRISM technique without platelet rich fibrin.
To compare the reduction in interdental black triangle height and width with and without Platelet rich fibrin
To evaluate patient related outcomes after PRISM technique with and without platelet rich fibrin
|
Baseline
1 week
1 month
3 months
6 months
|
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
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)
|
01/04/2026 |
| 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 Yet Recruiting |
| 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 randomized controlled clinical trial aims to comparatively evaluate the effectiveness of papilla reconstruction using the Papilla Reconstruction using Incision and Submucosal Mobilization technique with and without platelet rich fibrin as an adjunct
Systemically healthy patients aged 20 to 35 years presenting with interdental papilla loss in the anterior region will be selected Participants will be randomly allocated into two group The test group will receive papilla reconstruction using the PRISM technique with platelet rich fibrin The control group will receive papilla reconstruction using the PRISM technique without platelet rich fibrin
Clinical parameters related to interdental papilla fill and soft tissue healing will be assessed at baseline and at follow up intervals The outcomes of both groups will be compared to evaluate the additional benefit of platelet rich fibrin in papilla reconstruction |