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CTRI Number  CTRI/2025/01/078961 [Registered on: 17/01/2025] Trial Registered Prospectively
Last Modified On: 17/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Medical Device
Preventive
Dentistry
Other (Specify) [I-PRF and Hyaluronic acid gel will be injected to thin gingiva]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of injectable platelet rich fibrin and hyaluronic acid with microneedling in thin gums. 
Scientific Title of Study   Comparative Evaluation Of Injectable - Platelet Rich Fibrin And Hyaluronic Acid with Microneedling In Thin Gingival Phenotype - A Split Mouth Study 
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 Praise Jose 
Designation  Post Graduate Student 
Affiliation  Coorg Institute of Dental Sciences 
Address  Department of Periodontics ,Room No. 4 ,Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218
Department of Periodontics ,Room No. 4 ,Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218
Kodagu
KARNATAKA
571218
India 
Phone  7907195185  
Fax    
Email  praisjose@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Praise Jose 
Designation  Post Graduate Student 
Affiliation  Coorg Institute of Dental Sciences 
Address  Department of Periodontics ,Room No. 4 ,Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218
Department of Periodontics ,Room No. 4 ,Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218
Kodagu
KARNATAKA
571218
India 
Phone  7907195185  
Fax    
Email  praisjose@gmail.com  
 
Details of Contact Person
Public Query
 
Name  RADHIKA B 
Designation  PROFESSOR 
Affiliation  Coorg Institute of Dental Sciences 
Address  Department of Periodontics ,Room No. 4 ,Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218
Department of Periodontics ,Room No. 4 ,Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218
Kodagu
KARNATAKA
571218
India 
Phone  9742096982  
Fax    
Email  radika_b24@yahoo.co.in  
 
Source of Monetary or Material Support  
Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218 
 
Primary Sponsor  
Name  Dr. Praise Jose 
Address  Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218 
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 
Praise Jose  Coorg Institute of Dental Sciences  Department of Periodontics ,Room No. 4 ,Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218
Kodagu
KARNATAKA 
7907195185

praisjose@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board  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  Hyaluronic acid and Microneedling  Hyaluronic acid combined with microneedling injected at thin gingival phenotype of less than 1mm at 3mm below free gingival margin. 
Intervention  I-PRF and Microneedling  I-PRF and Microneedling combined procedure done at thin gingival phenotype of less than 1mm at 3mm below free gingival margin until blanching is seen 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Subjects with thin gingival phenotype of less than 1mm, plaque and gingival index less than 1 and bleeding on probing less than 10% 
 
ExclusionCriteria 
Details  Subjects who are systemically unhealthy, poor oral hygiene , pregnant and lactating mothers , alcoholics and smokers, patients undergoing active orthodontic treatment and patients taking any medication that cause gingival enlargement 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Increase in gingival thickness at anterior part of mandible with use of I-PRF and Microneedling  Increase in gingival thickness at anterior part of mandible with use of I-PRF and Microneedling
Gingival thickness will be measured at baseline ,1 month and 3 month respectiveley.Both hyaluronic acid,microneedling and i-prf will be administered during baseline,1month and 3rd month. 
 
Secondary Outcome  
Outcome  TimePoints 
Increase in gingival thickness at anterior mandible with use of Hyaluronic acid & Microneedling   Gingival thickness will be measured using a digital caliper at baseline ,1 month & 3 month after procedure.Both hyaluronic acid,microneedling & i-prf will be administered at baseline 1 month & 3rd month. 
 
Target Sample Size   Total Sample Size="17"
Sample Size from India="17" 
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)   03/02/2025 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

 Depending on the size, texture, location, and shape of the gingiva and alveolar process, each person has a distinct “Gingival Phenotype” that affects their periodontal response to inflammation and course of therapy.Individuals with thin-phenotype are more likely to experience gingival recession in the context of trauma and inflammation.Conventionally, surgical techniques like subepithelial connective tissue grafting and other augmentation procedures such as modified roll technique and acellular dermal matrix were found to be useful .Since patients are reluctant in doing surgical procedures, it has come  for the need of non-surgical therapies to enhance the gingival phenotype.Thus Microneedling, I-PRF and hyaluronic acid has been found to be an alternative choice for the treatment of thin gingival phenotype. Microneedling (MN) technique is a non-surgical procedure that is known as collagen induction therapy involving repetitive punctures on the skin. Over a petite period of time, it has expanded mass admiration and acceptance as it is a simple, inexpensive, and effective technique.PRF also induces higher fibroblast migration and expression of platelet-derived growth factor (PDGF), transforming growth factor B (TGF-B), and collagen-1 .Hyaluronic acid (HA), a naturally occurring polysaccharide, is considered an important component of the extracellular matrix in connective tissues of the human body.The unique biological and physiochemical properties of HA make it an interesting biomaterial for medical, cosmetic, and pharmaceutical applications.

In light of these factors, due to the positive effects of HA, MN and I-PRF on the biological potential, neoangiogenesis, neocollagenesis and wound-healing, the aim of this study is meant to compare the clinical efficacy of  micro-needling with  I-PRF and HA  in thin gingival phenotype.

 
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