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CTRI Number  CTRI/2025/07/091866 [Registered on: 28/07/2025] Trial Registered Prospectively
Last Modified On: 27/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing the effects of Microneedling assisted iPRF with and without hyaluronic acid for the treatment of maxillary black triangles 
Scientific Title of Study   Comparative Evaluation of Microneedling Assisted iPRF with and without Hyaluronic acid 2 percent Management of Anterior Maxillary Black Triangles A split mouth 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 Vrushali Lathiya 
Designation  Associate Professor 
Affiliation  Ranjeet Deshmukh Dental College and Research Centre, Hingna, Nagpur 
Address  104, Department of Periodontology and Implant Dentistry
Ranjeet Deshmukh Dental College and Research Centre, Hingna, Nagpur
Nagpur
MAHARASHTRA
440019
India 
Phone  09561100520  
Fax    
Email  drvrushalilathiya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vrushali Lathiya 
Designation  Associate Professor 
Affiliation  Ranjeet Deshmukh Dental College and Research Centre, Hingna, Nagpur 
Address  104 Department of Periodontology and Implant Dentistry
Ranjeet Deshmukh Dental College and Research Centre, Hingna, Nagpur
Nagpur
MAHARASHTRA
440019
India 
Phone  09561100520  
Fax    
Email  drvrushalilathiya@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vrushali Lathiya 
Designation  Associate Professor 
Affiliation  Ranjeet Deshmukh Dental College and Research Centre, Hingna, Nagpur 
Address  104 Department of Periodontolgy and Implant Dentistry
Ranjeet Deshmukh Dental College and Research Centre, Hingna, Nagpur
Nagpur
MAHARASHTRA
440019
India 
Phone  09561100520  
Fax    
Email  drvrushalilathiya@gmail.com  
 
Source of Monetary or Material Support  
none 
 
Primary Sponsor  
Name  self 
Address  104 Department of Periodontology and Implant Dentistry Ranjeet Deshmukh Dental College and Research Centre Nagpur 
Type of Sponsor  Research institution and hospital 
 
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 Vrushali Lathiya  Ranjeet Deshmukh Dental College and Research Centre, Hingna, Nagpur  104 Dept. of Periodontology and Implant Dentistry,Ranjeet Deshmukh Dental College and Research Centre, Hingna, Nagpur Ranjeet Deshmukh Dental College and Research Centre, Hingna, Nagpur
Nagpur
MAHARASHTRA 		 09561100520

drvrushalilathiya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethical committee, Ranjeet Deshmukh Dental College and Research Centre Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K060||Gingival recession,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Microneedling assisted iprf with hyaluronic acid 2 percent  Microneedling assisted iprf with hyaluronic acid 2 percent when used in maxillary anterior black triangles leads to enhanced interdental gingival augmentation 
Comparator Agent  Microneedling assisted iPRF without Hyaluronic acid 2 percent will be administered one time at the time of treatment and the outcomes will be evaluated after 1 week and 3 and 6 months   Microneedling assisted iPRF without Hyaluronic acid 2 percent will augment the inderdental gingiva 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Systemically healthy patients aged 20 to 75 years
Patient with healthy and stable soft tissue architecture
Patients presenting with Class 0 1 and 2 interdental papillary loss in the anterior maxilla as defined by the Jemt Papillary Index 1994
Patients with a probing depth of less than 4 mm
Patients with a gingival and plaque index of 0 to 1
 
 
ExclusionCriteria 
Details  Patients with systemic diseases that would have influenced bone or soft tissue metabolism
Pregnant or lactating females
Tobacco smokers.
Patient with a history of periodontal surgery in the last six months
Patients treated with any medication known to cause gingival hyperplasia
Patients with a history of allergic reactions drug and alcohol abuse
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the Papillary Fill using JemtPapillary Index 1977 at baseline
To evaluate the Papillary gain using Jemt Papillary Index 1977 at 1 3 and 6 months post treatment.
To measure the Papillary Width PW at baseline and 1 3 and 6 months post treatment
To evaluate the Papillary Deficient Height PH at baselineand 1 3 and 6 months post treatment
To estimate the area of the black triangle AoP at baseline and 1 3 and 6 months post treatment  		 To evaluate the Papillary Fill using JemtPapillary Index 1977 at baseline
To evaluate the Papillary gain using Jemt Papillary Index 1977 at 1 3 and 6 months post treatment.
To measure the Papillary Width PW at baseline and 1 3 and 6 months post treatment
To evaluate the Papillary Deficient Height PH at baselineand 1 3 and 6 months post treatment
To estimate the area of the black triangle AoP at baseline and 1 3 and 6 months post treatment  
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate patient reported outcomes at baseline and 6 months using VAS pain assessment scale and a questionnaire
 		 1 3 and 6 months 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   01/11/2026 
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="0"
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 splitmouth randomized controlled trial aims to evaluate and compare the effectiveness of microneedlingassisted delivery of injectable platelet rich fibrin  alone versus iPRF combined with 2 percent hyaluronic acid  in managing anterior maxillary black triangles caused by interdental papilla loss. Loss of papilla leads to esthetic and functional issues and while surgical treatments are invasive and unpredictable, microneedling and regenerative biomaterials like iPRF and HA offer minimally invasive alternatives Microneedling creates controlled microinjuries to stimulate collagen production and tissue regeneration while iPRF releases growth factors enhancing healing and HA maintains tissue hydration and promotes regeneration In this study papillary fill width height and black triangle area will be assessed at baseline 1 3 and 6 months along with patientreported outcomes on pain and satisfaction Eighty sites will be included divided equally between the two treatment groups The study will be conducted over six months in the Department of Periodontology and Implantology to determine whether the combination of iPRF and HA provides superior results compared to iPRF alone in regenerating interdental papilla and improving esthetics

 
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