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CTRI Number  CTRI/2024/08/072966 [Registered on: 23/08/2024] Trial Registered Prospectively
Last Modified On: 08/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   comparion of hyaluronic acid and injectable platelet rice fibrin(I-PRF) for the treatment of space present in between the two teeth due to receding gums  
Scientific Title of Study   Comparative evaluation of Hyaluronic Acid and injectable Platelet Rich Fibrin (I-PRF) as a non-surgical approach for management of black triangle  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mansi Pal 
Designation  pg junior resident 
Affiliation  king georges medical university 
Address  room No - 14, 5th floor ,PG clinic, New dental building, Department of Periodontology, Faculty of dental sciences King georges medical university lucknow UTTAR PRADESH

Lucknow
UTTAR PRADESH
226003
India 
Phone  7017636748  
Fax    
Email  mansi.261297@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Pro fDr Nand Lal 
Designation  Proffesor and Head Department of Periodontology 
Affiliation  king georges medical university 
Address  room No - 1, 5th floor , New dental building, Department of Periodontology, Faculty of dental sciences King georges medical university lucknow UTTAR PRADESH

Lucknow
UTTAR PRADESH
226003
India 
Phone  9415085653  
Fax    
Email  nandlalkgmc@yahoo.in  
 
Details of Contact Person
Public Query  
Name  Pro fDr Nand Lal 
Designation  Proffesor and Head Department of Periodontology 
Affiliation  king georges medical university 
Address  room No - 1, 5th floor , New dental building, Department of Periodontology, Faculty of dental sciences King georges medical university lucknow UTTAR PRADESH

Lucknow
UTTAR PRADESH
226003
India 
Phone  9415085653  
Fax    
Email  nandlalkgmc@yahoo.in  
 
Source of Monetary or Material Support  
Department of Periodontology Faculty of dental sciences king georges medical university lucknow Uttar Pradesh India 226003 
 
Primary Sponsor  
Name  Mansi Pal 
Address  Department of Periodontology Faculty of dental sciences king georges medical university lucknow Uttar Pradesh India 226003 
Type of Sponsor  Other [SELF- (Principle investigator)] 
 
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 
Mansi Pal  King georges medical university  Room 14 pg clinic 5th floor new dental building department of periodontology king georges medical university
Lucknow
UTTAR PRADESH 		 7017636748

mansi.261297@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
King georges medical university u.p institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  black space present in between two teeth 
Patients  (1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  hyaluronic acid  3 doses of commercially available hyaluronic acid will be given at each papilla site: at baseline, 3-week and 6-weeks intervals. 
Comparator Agent  i-prf   Blood sample will be collected in a test tube after that centrifugation will be done for 3 minutes at a low speed (700rpm) to produce a yellow- orange color fluid that is known as injectable platelet-rich fibrin, after that this fluid will be injected to the papilla site. Three doses will be given at each papilla site: at baseline, 3-week and 6-weeks intervals. 
 
Inclusion Criteria  
Age From  18.00 Day(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Above 18 years of age
2. Papillary deficiency types I or II, according to Nordland and Tarnow classification (1998) will be selected.
3. Teeth free from caries, proximal restorations, fixed prosthesis or orthodontic appliances will be selected.
4. Patients willing to participate in the study

5. Systemically healthy patients
 
 
ExclusionCriteria 
Details  1. Papillary deficiency types III according to Nordland and Tarnow classification 1998.
2. Open contacts between affected teeth.
3 Subjects suffering from any systemic diseases or systemic conditions
4. Pregnant and lactating women
5. Smokers
7. Alcoholics
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
closure of black triangle or reconstruction of interdental papilla  three doses given at each papilla at baseline,3 weeks ,6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
no food lodgement occur so pocket formation decreases.  6th weeks 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/09/2024 
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="1"
Months="0"
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   The interdental papillary deficiency or the Black triangle (BT)" is a large concern for dentists and patients. Loss of interdental papilla may lead to the formation of unappealing dark triangles, resulting in food impaction and plaque buildup. This soft tissue is delicate and fragile; is susceptible to inflammation leading to recession, bone loss or both , due to its low blood supply. In addition to positively affecting smile esthetics, interdental papillae are important to prevent the impaction of food between the teeth and important role in improved phonetics . Non-surgical attempts to treat, these methods are invasive and time-consuming.Non-surgical attempts to treat, these methods are invasive and time-consuming.
Hyaluronic acid (HA) is an essential glycosaminoglycan of the extracellular matrix of the periodontal tissues, and the majority of cells can produce it during several phases of their cell cycle. It is involved in tissue repair and wound healing by stimulating cell proliferation, migration and interaction with several growth factors.
HA has a crucial role in space-filling owing to its hygroscopic nature. Moreover, it regulates osmotic pressure and enhances tissue lubrication and resiliency, which helps in maintaining the structural and homeostatic integrity of tissues the injection of HA showed promising clinical efficacy in the treatment of gingival papilla defects in several studies.
Platelet rich fibrin (PRF) is a type of platelet gel; a matrix of autologous fibrin, which has scored over platelet rich plasma by virtue of its properties, ease of preparation, and cost effectiveness. Platelet cytokines, platelet derived growth factors (PDGF)-α and (PDGF)-β, transforming growth factor beta (TGF)-β and insulin-like growth factor-1 (IGF-1) are gradually released as fibrin matrix is resorbed, aiding the process of healing.
“Injectable platelet-rich fibrin (I-PRF) ”is the most recent and successful advancement in PRF.  I-PRF is referred to be an advanced type of PRF since it is injected (autologous PRF) into afflicted soft tissues, mucous membranes, or skin. It also has special qualities in the regeneration of human tissues. Gene therapy, tissue engineering, and platelets have all been demonstrated to be effective sites for signaling pathways such as platelet-derived growth factor.  that i-PRF demonstrated the ability to release higher concentrations of various growth factors and induced higher fibroblast migration and expression of PDGF, TGF-β, and  collagen .

The purpose of this study is to check the clinical efficacy of injectable- platelet rich fibrin (I- PRF) in comparison to commercially available Hyaluronic acid injections for the treatment of Black triangle.

PROCEDURE : written informed consent form explaining the nature of the study and procedure will be explained to the patient and duly signed by the patient.

v Pre operating phase: Consisting of oral hygiene instructions, scaling, root planing.

v Maintenance phase:  

·       Baseline recording of clinical parameters

Ø  The degree of papillary deficiency will be recorded according to Nordland and Tarnow classification(1992).

Ø Distance between the contact point of affected teeth to the tip of the papillary point will be measured.

Ø Clinical photographs will be taken.

v Injection phase:

·       Group A: Hyaluronic Acid Group

Ø 3 doses of commercially available hyaluronic acid will be given at each papilla site: at baseline, 3-week and 6-weeks intervals.

·      Group B: Injectable-Platelet Rich Fibrin (I-PRF) Group

Ø Blood sample will be collected in a test tube after that centrifugation will be done for 3 minutes at a low speed (700rpm) to produce a yellow- orange color fluid that is known as injectable platelet-rich fibrin, after that this fluid will be injected to the papilla site. Three doses will be given at each papilla site: at baseline, 3-week and 6-weeks intervals.

v 

 
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