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CTRI Number  CTRI/2022/05/042683 [Registered on: 19/05/2022] Trial Registered Prospectively
Last Modified On: 18/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing two techniques using blood derived product for treatment of thin gum tissues in healthy individuals. 
Scientific Title of Study   Comparative evaluation of the injectable platelet rich fibrin (i-PRF) with and without micro-needling for gingival augmentation in thin gingival phenotype - A randomized clinical trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  B NAMRATHA SAI 
Designation  Post graduate student 
Affiliation  narayana dental college and hospital 
Address  Room no 5 department of periodontology narayana dental college and hospital chintareddypalem

Nellore
ANDHRA PRADESH
524003
India 
Phone  9392214267  
Fax    
Email  namrathasai2803@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SREENIVAS NAGARAKANTI 
Designation  Professor 
Affiliation  Narayana dental college and hospital 
Address  Room no 5 department of periodontology Narayana dental college and hospital chintareddypalem

Nellore
ANDHRA PRADESH
524003
India 
Phone  9985664566  
Fax    
Email  sreenivasnagarakanti@gmail.com  
 
Details of Contact Person
Public Query  
Name  SREENIVAS NAGARAKANTI 
Designation  Professor 
Affiliation  NARAYANA DENTAL COLLEGE AND HOSPITAL 
Address  Room no 5 department of periodontology narayana dental college and hospital chintareddypalem

Nellore
ANDHRA PRADESH
524003
India 
Phone  9985664566  
Fax    
Email  sreenivasnagarakanti@gmail.com  
 
Source of Monetary or Material Support  
DR B NAMRATHA SAI Department of periodontology Narayana dental college and hospital Chintareddypalem Nellore Andhra Pradesh 524003 
 
Primary Sponsor  
Name  DR B NAMRATHA SAI 
Address  Room no 5 department of periodontology Narayana dental college and hospital chintareddypalem 524003 
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 
B NAMRATHA SAI  NARAYANA DENTAL COLLEGE AND HOSPITAL  ROOM NO5 SECOND FLOOR DEPARTMENT OF PERIODONTOLOGY NARAYANA DENTAL COLLEGE AND HOSPITAL
Nellore
ANDHRA PRADESH 		 9392214267

namrathasai2803@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICAL COMMITTEE  Approved 
INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R69||Illness, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  gingival augmentation using injectable platelet rich fibrin along with microneedling technique.   the entire procedure will be performed under local anesthesia and aseptic conditions. on the thin gingiva of the mandibular anterior teeth and premolars microneedling will be performed using lancet needle. At the mucogingival junction injectable platelet rich fibrin is injected which is derived from the patients blood. this procedure is carried for 4 times in the same site at an interval of 10 days. 
Comparator Agent  gingival augmentation using injectable platelet rich fibrin.  the entire procedure will be performed under local anesthesia and aseptic conditions. At the mucogingival junction injectable platelet rich fibrin is injected which is derived from the patients blood. this procedure is carried for 4 times in the same site at an interval of 10 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  Age18- 45years.
Gingival thickness of mandibular anterior and premolars with thin gingival phenotype (≤ 0.8mm.)
No blood borne conditions.
Full mouth plaque index and Bleeding on probing score ≤15% (total score should be less than ≤15% of the maximum score).
Systemically healthy patients.
 
 
ExclusionCriteria 
Details 
Active orthodontic treatment.
Use of tobacco in any form.
Previous periodontal surgery.
Systemic diseases.
Use of blood thinners.
Use of any drug that might lead to gingival enlargement.
Bruxism.
Malocclusion, crowding, fillings, missing and supernumerary teeth.

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the changes in gingival thickness, keratinized tissue width, clinical attachment level and probing depth .

 		 Baseline, 1month, 3months and 6months.

 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the changes in plaque index, gingival index and modified sulcular bleeding index.  Baseline, 6months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   01/06/2022 
Date of Study Completion (India) 15/11/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  		  AIM: The aim of this present study is to compare and evaluate the therapeutic effect of injectable platelet rich fibrin alone and injectable platelet rich fibrin in combination with microneedling on the thickness and width of keratinized gingiva in individuals with thin gingival phenotypes. 
All the participants will be explained about the aim, nature, and design of the study along with a written informed consent  for their participation before the commencement of the study. 
The study is planned as  a randomized clinical trial conducted in healthy individuals with thin gingival phenotype . The study duration is 6 months in which the clinical parameters will be recorded at baseline, 1, 3 and 6 months.
The study will be performed in accordance with the Helsinki Declaration of 1975, as revised in 2013.
The clinical parameters for assessment include: 
 1)Gingival thickness
 2)Keratinized tissue width
 3)Clinical attachment level
 4)Probing depth
 5)Plaque index 
 6)Gingival index
 7)Modified sulcular bleeding index.
All patients included in the study will be evaluated before the treatment procedure and patients with thin gingival phenotype in the mandibular anterior teeth and premolars are selected. 
Two sites left and right halves of the mandibular arch will be selected and assigned as test and control group.
Test group:      gingival augmentation with microneedling and injectable platelet rich fibrin.
control group:  gingival augmentation with injectable platelet platelet rich fibrin.

Procedure: The thickness of the gingiva will be measured using No:15 endodontic spreader. The spreader will be inserted perpendicularly at 1.5 mm apical to the gingival margin in the mid-buccal region through the soft tissues until a hard surface was felt. The silicon disk(stopper) will be laid in tight contact with the soft tissue surface and will be attached with a drop of cyano-acrylic adhesive. The penetration depth between the silicone disc and the spreader tip will be measured using digital vernier calliper.

PREPARATION OF INJECTABLE PLATELET RICH FIBRIN:  Before all procedures, a venous blood sample will be collected once for each patient using a 20-ml syringe and will be separated into two i-PRF tubes of 10 ml each containing no anticoagulant and will be centrifuged at room temperature for 8 minutes at 600 rpm (44g force).The injectable platelet rich fibrin obtained will be placed in 2.5 cc dental injectors. The 27-gauge dental injector needles will be used for injection of injectable platelet rich fibrin. 

MICRONEEDLING: Thirty-gauge (0.255 mm) lancet needles will be vertically inserted into the tissue until the hard tissue is reached. Microneedling will be carried out on keratinized gingiva from the mesial line angle to the distal line angle of the tooth to be treated with the help of a lancet. 

ADMINISTRATION PROTOCOL: A total of 4 sessions of microneedling and injectable platelet rich fibrin procedure will be administered to individuals at 10- day intervals. 

Injectable platelet rich fibrin Group: Only injectable platelet rich fibrin will be injected into the apical region of the mucogingival margin in alveolar mucosa of the study area.

Microneedling+ injectable platelet rich fibrin Group: After microneedling procedure is completed in keratinized tissue, injectable platelet rich fibrin will be injected into the apical region of the mucogingival margin in alveolar mucosa of the study area.

The clinical measurements of the patients will be taken once at baseline then after 1 month, 3 months, 6 months.


 
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