| CTRI Number |
CTRI/2025/09/094751 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Study in people with gaps between gums and teeth comparing platelet-rich fibrin and placental extract to improve gum appearance. |
|
Scientific Title of Study
|
Comparative Evaluation of Injectable Platelet Rich Fibrin and Placental Extract in the Management of Gingival Black Triangles. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Moturi Padmini Raj |
| Designation |
Post Graduate Student |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Room no 8,2nd floor, Department of Periodontology Sibar institute of dental sciences, Takellapadu, Guntur,522509
Guntur ANDHRA PRADESH 522509 India |
| Phone |
9000198079 |
| Fax |
|
| Email |
prajmoturi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr K Lakshmi Kanth |
| Designation |
Professor |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Room no.8,2nd floor, Department of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu,Guntur,522509
Guntur ANDHRA PRADESH 522509 India |
| Phone |
9441081047 |
| Fax |
|
| Email |
drkanth99@yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Moturi Padmini Raj |
| Designation |
Post Graduate Student |
| Affiliation |
Sibar Institute Of Dental Sciences |
| Address |
Room no 8,2nd floor, Department of Periodontology Sibar institute of dental sciences, Takellapadu, Guntur,522509
Guntur ANDHRA PRADESH 522509 India |
| Phone |
9000198079 |
| Fax |
|
| Email |
prajmoturi@gmail.com |
|
|
Source of Monetary or Material Support
|
| sibar institute of dental sciences takkellapadu Guntur Andhra pradesh India 522509 |
|
|
Primary Sponsor
|
| Name |
Moturi Padmini Raj |
| Address |
Room no.8,2nd floor, Department of Periodontics, Sibar Institute of Dental Sciences,Takkellapadu,522509 |
| 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 Moturi Padmini Raj |
Sibar Institute of Dental Sciences |
Room no-8,2nd floor, Departnment of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu,522509
Guntur ANDHRA PRADESH |
9000198079
prajmoturi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sibar Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
i-PRF |
i-PRF will be injected in deficient interdental papillary region and clinical parameters will be recorded at baseline, 1 month and 3 months |
| Intervention |
placental extract injection |
0.2 mL of a placental extract (Placentrex®) will be injected in deficient interdental papillary region and clinical parameters will be recorded at baseline, 1 month and 3 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1. Individuals with age group of 20-45 years of either gender.
2. Patients with PPI 2 interdental papillary loss with no radiographic evidence of bone
loss in maxillary anterior tooth region.
3. Respective teeth are free from caries with no fixed prosthesis or orthodontic appliance.
|
|
| ExclusionCriteria |
| Details |
1. Patients with systemic disease
2. Pregnant and lactating women.
3. Any forms of tobacco users.
4. Patients consuming drugs causing gingival hyperplasia.
5. Patient who had undergone periodontal plastic surgery for the selected area in the last
1 year.
6. Adjacent teeth with caries, fixed prosthesis, or orthodontic appliance.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Interdental papillary height |
baseline,1 and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•Papillary Bleeding Index (PBI)
•Morphometric analysis of images:
Black Triangle Height (BTH)
Black Triangle Width (BTW)
Black Triangle Area (BTA)
|
baseline,1 and 3 months |
|
|
Target Sample Size
|
Total Sample Size="28" Sample Size from India="28"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="28" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/10/2025 |
| Date of Study Completion (India) |
30/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0" Months="3" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 is a
randomized, parallel group clinical trial comparing the efficacy of the
placental extract and i-PRF for the management of deficient interdental
papilla. Interdental papillary deficiency creates open gingival embrasures,
also called “black triangles” which
compromises
esthetics, increases the retention of food debris and causes phonetic problems. Various surgical and non-surgical
approaches have been put forth for the management of the black triangles
Placenta is
enriched with mesenchymal cells which have the capacity to differentiate into
different types of cells. It promotes fibrogenesis, neo angiogenesis and
epithelialization thus boosting the wound healing. It also has anti-inflammatory,
antimicrobial, immune stimulating, anti-platelet aggregation properties.
Injectable
platelet-rich fibrin (i PRF), is a second-generation autologous platelet
concentrate. It promotes tissue regeneration, wound healing, improves
angiogenesis and has an anti-inflammatory and anti-microbial property.
All the
patients will receive phase I therapy which include supragingival and
subgingival scaling and root planning. Patients will be recalled after
one-week and clinical parameters such as Papillary Bleeding Index and
Interdental Papillary Height will be recorded before the procedure. Pre
operative photographs will be taken and ImageJ software program will be used
to measure BTH, BTW and BTA. After administration of a local anaesthesia 2%
lignocaine containing adrenaline 1:80,000. The needle will be inserted at a
45o angle in an area 2 to 3 mm below the interdental papilla tip.
Group A :0.2 mL
of a placental extract (Placentrex®) Group B: 0.2 mL of i-PRF. Patient will be
recalled after 1 and 3 months for recording clinical parameters.
Post-operative photographs will be taken to measure BTH, BTW and BTA.
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