FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/12/029924 [Registered on: 18/12/2020] Trial Registered Prospectively
Last Modified On: 30/12/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   USE OF INJECTABLE FORMS OF HYALURONIC ACID AND PLATELET RICH FIBRIN IN THE TREATMENT OF GUM LOSS IN BETWEEN TWO TEETH 
Scientific Title of Study   COMPARISON OF INJECTABLE FORMS OF HYALURONIC ACID AND PLATELET RICH FIBRIN IN THE TREATMENT OF INTERDENTAL PAPILLARY LOSS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ANEESHA GUPTA 
Designation  POST GRADUATE STUDENT 
Affiliation  Institute of Dental Studies and Technologies 
Address  Department of Periodontology, Institute of Dental Studies and Technologies, NH-58, Delhi-Meerut Road, Kadrabad, Modinagar Ghaziabad UTTAR PRADESH 201201 India
Department of Periodontology, Institute of Dental Studies and Technologies, NH-58, Delhi-Meerut Road, Kadrabad, Modinagar Ghaziabad UTTAR PRADESH 201201 India
Ghaziabad
UTTAR PRADESH
201201
India 
Phone  8715014786  
Fax    
Email  aneeshagupta03@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Komal Puri 
Designation  Reader 
Affiliation  Institute of Dental Studies and Technologies 
Address  Department of Periodontology, Room number 7, Institute of Dental Studies and Technologies, Modinagar Ghaziabad UTTAR PRADESH
Department of Periodontology, Room number 7, Institute of Dental Studies and Technologies, Modinagar Ghaziabad UTTAR PRADESH
Ghaziabad
UTTAR PRADESH
201201
India 
Phone  9818190603  
Fax    
Email  komal_arora09@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Manish Khatri  
Designation  Head of Department 
Affiliation  Institute of Dental Studies and Technologies 
Address  Department of Periodontology, Room number 7, Institute of Dental Studies and Technologies, Modinagar Ghaziabad UTTAR PRADESH
Department of Periodontology, Room number 7, Institute of Dental Studies and Technologies, Modinagar Ghaziabad UTTAR PRADESH
Ghaziabad
UTTAR PRADESH
201201
India 
Phone  9810720335  
Fax    
Email  drmanishkhatri@yahoo.com  
 
Source of Monetary or Material Support  
Hyaluronic acid (Bioscience, Germany) 
 
Primary Sponsor  
Name  Institute of Dental Studies and Technologies 
Address  Department of Periodontology, Institute of Dental Studies and Technologies, NH-58, Delhi-Meerut Road, Kadrabad, Modinagar 
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 Aneesha Gupta   Institute of Dental Studies and Technologies  Institute of Dental Studies and Technologies, Department of Periodontology, Room number 7, NH-58, Delhi-Meerut Road, Kadrabad, Modinagar, Uttar Pradesh, India-201201
Ghaziabad
UTTAR PRADESH 		 8715014786

aneeshagupta03@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethical Committee of Institute of dental studies and technologies  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Hyaluronic acid (HA) is a FDA approved.  Formed by disaccharide units, is non-immunogenic, enzymatically degradable and relatively non adhesive to cells and proteins and capable of interacting with a number of receptors resulting in the activation of signaling cascades that influence cell migration, proliferation and gene expression. It binds to water and swells when in gel form, resulting in smoother tissue contours. 
Comparator Agent  Injectable platelet rich fibrin  Most recently, major development in the field of platelet concentrates is a liquid version of PRF termed injectable PRF( i-PRF), which is prepared using the concept of ‘low speed centrifugation’ (700rpm for 3 minutes at 60 G) which makes less number of cells to migrate towards the bottom of centrifuge tubes as compared to conventional centrifugation technique of PRF preparation. Hence, the liquid PRF obtained as the top most layer has a higher percentage of cells including platelets and leukocytes, thereby providing more cells capable of assisting in tissue regeneration and the release of pro-wound healing molecules. i-PRF has been used in various procedures like implants for faster wound healing, thickening of gingival biotype and bone augmentation along with the use of bone grafts. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  • Patients in good general health
• Patients with at least one Type I or II (Norland and Tarnow’s classification)7 deficient papilla in anterior region
• Well aligned maxillary teeth, no spacing, no crowding or intrusion or extrusion.
 
 
ExclusionCriteria 
Details  • Pregnant and lactating mothers
• History of tobacco consumption.
• History of taking any medications which are known to increase the risk of gingival hyperplasia.
• Any artificial crown, proximal cervical restoration or abrasion of maxillary anterior teeth.
• Any known allergy with hyaluronic acid
• Patients with history of traumatic oral hygiene measures or periodontal surgeries over the last 6 months at the area of interest
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
2. Clinical measurement: distance from the contact point (CP) to papillary tip using the prepared stent
3. Photographic measurement:
4. Radiographic measurement.
The following distances will be measured
a. Distance from CP to crest of the bone (BC)
b. Interdental width at the level of facial CEJ
 		 follow up at 15th day, 1, 2, 3,4,5,6 months and the clinical and photographic parameters will be re-recorded 
 
Secondary Outcome  
Outcome  TimePoints 
1. A questionnaire for assessment of patient’s response including questions regarding patient’s assessment of black triangle  First day of treatment and after 6 months  
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   24/12/2020 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not published 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

This study will be conducted and compiled by Dr. Aneesha Gupta, Dr.Komal Puri, Dr.Manish Khatri, Dr.Mansi Bansal, Dr. Sujata Masamatti, Dr.Rehan Khan at Department Of Periodontology, Institute of Dental Studies and Technologies, Kadrabad, Modinagar, Uttar Pradesh, India

The study is a randomized control trial for comparison of injectable forms of  hyaluronic acid and platelet rich fibrin in the treatment of interdental papillary loss. Type 1 and Type 2 papillary loss patients will be included and the clinical and photographic measurements  will be recorded at baseline and thereafter at 15 days, 1 month, 2 ,3 ,4 ,5 and 6 months post treatment and radiographic measurements will be recorded at baseline and after 6 months post treatment.


 
Close