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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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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