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CTRI Number  CTRI/2023/06/053877 [Registered on: 14/06/2023] Trial Registered Prospectively
Last Modified On: 10/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of effect of two different blood products for the treatment of receeding gums- A controlled randomized clinical study  
Scientific Title of Study   Comparative evaluation of efficacy of PRF & T-PRF for treatment of Cairo’s class I and II gingival recession A randomized controlled study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Richa Saroj 
Designation  Post Graduate Student 
Affiliation  K.M Shah Dental College and Hospital, Sumandeep Vidyapeeth 
Address  room no 7, department of periodontology, K. M Shah Dental College and Hospital, Sumandeep Vidyapeeth, Piparia, Waghodia Road, Vadodara, Gujarat-391760

Vadodara
GUJARAT
391760
India 
Phone  7208892027  
Fax    
Email  richasaroj43@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Monali Shah 
Designation  H.O.D, professor and PG guide 
Affiliation  K.M Shah Dental College and Hospital, Sumandeep Vidyapeeth 
Address  room no. 7 department of periodontology, K. M Shah Dental College and Hospital, Sumandeep Vidyapeeth, Piparia, Waghodia Road, Vadodara, Gujarat-391760

Vadodara
GUJARAT
391760
India 
Phone  9824003228  
Fax    
Email  smonali2011@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Richa Saroj 
Designation  Post Graduate Student 
Affiliation  K.M Shah Dental College and Hospital, Sumandeep Vidyapeeth 
Address  Room no 7, department of periodontology, Sumandeep Vidyapeeth, Piparia, Waghodia Road, Vadodara, Gujarat-391760

Vadodara
GUJARAT
391760
India 
Phone  7208892027  
Fax    
Email  richasaroj43@gmail.com  
 
Source of Monetary or Material Support  
K.M. SHAH dental college and hospital, sumandeep vidyapeeth Dr. Monali Shah, Room no 7 department of periodontology K.M Shah dental college and hospital 
 
Primary Sponsor  
Name  Dr. Richa Saroj 
Address  Vama Girls Hostel, Sumandeep Vidyapeeth, Piparia, Waghodia Road, Vadodara, Gujarat-391760 
Type of Sponsor  Other [Self Funded] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Monali Shah  Room No:7, K.M Shah Dental College and Hospital, Sumandeep Vidyapeeth, Piparia, Waghodia Road, Vadodara, Gujarat-391760 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Richa Saroj  K.M Shah Dental College and Hospital  Room no 7, department of periodontology, K.M.Shah dental college and hospital, piparia, waghodia road, vadodara-391760
Vadodara
GUJARAT 
7208892027

richasaroj43@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Sumandeep Vidyapeeth Institutional Ethics Committee (SVIEC)  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 
Comparator Agent  PRF  Platelet Rich Fibrin (PRF) is the second generation platelet concentrate, developed first by Choukroun, et al. in PRF is a three-dimensional fibrin network that promotes accelerated wound healing, immunity and effective neovascularization, and it supports the three crucial steps of wound healing: ‘angiogenesis’, ‘immunity’ and ‘epithelial proliferation’. In addition, PRF, an autogenous fibrin matrix formed only of concentrated blood, provides successful clinical outcomes for the treatment of soft-tissue defects and comparable keratinized tissue gain and tissue thickness when combined with connective tissue grafts. resorption time is 7-11 days 
Intervention  T-PRF   T-PRF plays an important role in increasing soft tissue thickness. T-PRF is promising, especially in soft and hard tissue augmentation, due to its Fibrin structure, which is tighter than that of L-PRF, and it is prepared in Grade IV titanium tubes. It produces faster epithelization, less postoperative bleeding, and better wound healing than spontaneous healing. T-PRF also has osteoinductive properties similar to those of bone and preserves tissue volume. It has been found that it has better bio-compatibility, thin fibrin meshwork, and long resorption time when compared to other generations of platelet concentration resorption time is 18-21 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Participants between 18 and 50 years of age
2. Cairo Class I or II gingival recession defects measuring ≥ 2mm.
3. Vital teeth, free of faulty restorations.
4. Patients who gave informed consent for the study.
 
 
ExclusionCriteria 
Details  1. History of smoking or tobacco consumption
2. Pregnant or lactating women
3. Patient with active periodontal infection.
4. Patients with systemic condition that contraindicate surgery.
5. Patients with removable or fixed dentures in the area of interest.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Width of keratinized Tissue
2. Recession Height
3. Recession Width 
Baseline - on the day of surgery & at 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1. Percentage Root Coverage
2. Thickness of Attached Gingiva 
Baseline- on the day of surgery & at 3 months 
 
Target Sample Size   Total Sample Size="36"
Sample Size from India="36" 
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   Phase 4 
Date of First Enrollment (India)   01/07/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Gingival recession is the apical migration of gingival margin to the cemento-enamel junction (CEJ). The distance between the CEJ and gingival margin gives the level of recession. Gingival recession can be caused by periodontal disease, accumulations, inflammation, improper flossing, aggressive tooth brushing, incorrect occlusal relationships, and dominant roots. These can appear as localized or generalized gingival recession. Although connective tissue graft is a gold standard procedure, PRF can be used as an alternative procedure by keeping patient’s comfort in mindPRF is a three-dimensional fibrin network that promotes accelerated wound healing, immunity and effective neovascularization, and it supports the three crucial steps of wound healing: ‘angiogenesis’, ‘immunity’ and ‘epithelial proliferation’. In addition, PRF, an autogenous fibrin matrix formed only of concentrated blood, provides successful clinical outcomes for the treatment of soft-tissue defects and comparable keratinized tissue gain and tissue thickness when combined with connective tissue grafts. A newer platelet concentrate i.e. Titanium Activated PRF (T-PRF) is a 3rd generation platelet concentrate that helps in regeneration of tissue. Titanium-Prepared, Platelet-Rich Fibrin (T-PRF) was recently developed by Tunali, et al. that avoids any negative effects caused by dry glass or glass-coated plastic tubes. The method is built on the concept that Titanium tubes are much more effective than glass tubes at stimulating clotting factors than Chouckroun’s method. T-PRF plays an important role in increasing soft tissue thickness. 

 
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