| CTRI Number |
CTRI/2025/08/093895 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Reconstruction Of Black Triangle Using i-PRF And Laser In Patients With Loss Of Interdental Papilla |
|
Scientific Title of Study
|
Clinical Efficacy of Injectable Platelet-Rich Fibrin (i-PRF) Versus Hemolaser Therapy for Interdental Papilla Reconstruction in Comparison to Non-Surgical Periodontal Therapy: 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. Madhumitha M |
| Designation |
Postgraduate Student |
| Affiliation |
Manipal College of Dental College |
| Address |
Room 7
Floor 4
Department Of Periodontology
Manipal College Of Dental College
KMC
Lighthouse hill road
Hampankatta
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
8489457979 |
| Fax |
|
| Email |
mmitha.16@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sangeeta U Nayak |
| Designation |
Professor |
| Affiliation |
Manipal College of Dental College |
| Address |
Room 7
Floor 4
Department Of Periodontology
Manipal College Of Dental College
KMC
Lighthouse hill road
Hampankatta
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9880718372 |
| Fax |
|
| Email |
sangeeta.nayak@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sangeeta U Nayak |
| Designation |
Professor |
| Affiliation |
Manipal College of Dental College |
| Address |
Room 7
Floor 4
Department Of Periodontology
Manipal College Of Dental College
KMC
Lighthouse hill road
Hampankatta
Dakshina Kannada
KARNATAKA
575001
India |
| Phone |
9880718372 |
| Fax |
|
| Email |
sangeeta.nayak@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Dental Sciences
Mangalore
Karnataka
India
575001 |
|
|
Primary Sponsor
|
| Name |
Madhumitha M |
| Address |
Manipal College Of Dental Sciences Mangalore
Karnataka
India
575001 |
| 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 |
| DrMadhumitha M |
Manipal College Of Dental Sciences Mangalore |
Room 7
Floor 4
Department Of Periodontology
Manipal College Of Dental College
KMC
Lighthouse hill road
Hampankatta
Dakshina Kannada
KARNATAKA |
8489457979
mmitha.16@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hemolaser Therapy |
The modified Hemolaser therapy PBM protocol will begin with the initial PBM application (T1 – First Session) using a 635 nm diode laser at four points: the coronal third, apical third, mesial side, and distal side of the papilla. Bleeding will then be induced inside the sulcus between the papillary defect by applying pressure on the junctional epithelium and supracrestal connective tissue using a 1/3 Gracey curette, allowing stimulated blood to fill the "black triangle" coronal to the interdental papilla, which will be left undisturbed. A second PBM application will then be performed at the same four points after the space is filled with blood.
Procedure to be done on
day 1
day 5
day 10
Follow up to be done
2 weeks
1 month
3 months
6 months |
| Intervention |
Injectable Platelet-Rich Fibrin (i-PRF) |
10 ml of intravenous blood will be withdrawn from antecubital region and will be centrifuged using plastic tubes (without any additives) in a centrifuge at 700 rpm for 3 min. The needle of the insulin syringe will be inserted 2–3 mm apical to the PT directed coronally making an angle of 45° to the long axis of the tooth with its bevel facing apically.
Follow up to be done at
2 weeks
1 month
3 months
6 months |
| Comparator Agent |
Non-surgical periodontal therapy |
The control group treatment will include oral hygiene instructions (OHI), which will cover proper brushing techniques using the Modified Bass technique and routine professional scaling and root planing.
AT 2 weeks
1 month
3 month
6 month |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age group between 18-60 years.
2.Patients with Papilla Presence Index 2 (PPI 2) and Papilla Presence Index 3 (PPI 3) interdental papillary loss score with radiographic evidence of no bone loss (Cardaropoli et al,2004)
3.Patients with a plaque index and gingival index score between zero and one.
4.Patients having Periodontal probing depth less than 3mm
5.Vertical distance from the interdental contact point to the crest of the interdental bone less than 5mm measured from intra oral periapical radiograph.
|
|
| ExclusionCriteria |
| Details |
1.Patients with known systemic disease or blood dyscrasias or on any medication known to interfere with the outcomes of periodontal therapy.
2.Smokers, pregnant women, and nursing mothers.
3.Patients having open contact.
4.Patients having PPI 4 score. (Cardaropoli et al,2004)
5.Previously treated for periodontal reasons before 6 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Papilla presence index
2. Papillary width
3. Papillary height
4. Papillary deficient area
|
1 month
3 months
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VAS Esthetic Score |
1 month
3 months
6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/10/2025 |
| 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 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 trial aims to evaluate and compare the effectiveness of Injectable Platelet-Rich Fibrin (i-PRF) and Hemolaser Therapy in the reconstruction of the interdental papilla, with a non-surgical control group for baseline comparison. The study will be conducted over 6 months to 1 year at the Department of Periodontology, MCODS, Mangalore. Study Groups include -
Control Group – Receives oral hygiene instructions, supportive periodontal care, and professional cleaning as needed, without regenerative or laser intervention. -
Test Group 1: i-PRF – Autologous i-PRF will be prepared by centrifuging 10 ml of blood at 700 rpm for 3 minutes. The obtained fibrin will be injected into papillary-deficient sites using a specific angulated technique under anesthesia, followed by gentle massage of the papilla. -
Test Group 2: Hemolaser Therapy – A modified PBMT protocol using a 635 nm diode laser is applied to four points around the papilla. Blood is induced into the papillary space by curettage and then irradiated again. The procedure is repeated on Day 5 and Day 10. Outcomes Measured Clinical parameters: papilla fill, tissue volume, and esthetic outcomes Patient-reported esthetic satisfaction Stability of regenerated papilla at 1, 3, and 6 months Analysis:
Photographic evaluation using Image J software with standardized imaging techniques and calibration against a periodontal probe will be used for quantitative assessment. This study explores the regenerative potential and patient-centered outcomes of i-PRF and Hemolaser Therapy for minimally invasive interdental papilla reconstruction. |