FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/064509 [Registered on: 20/03/2024] Trial Registered Prospectively
Last Modified On: 20/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To check the efficiency of two different techniques for the treatment of gum recessions  
Scientific Title of Study   Comparison Between Microsurgical and Macrosurgical Techniques for the Treatment of Gingival Recessions using Coronally Advanced Flap and Platelet Rich Fibrin -A Randomized Controlled Clinical Trial 
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 Shahanaz Shaik 
Designation  Postgraduate 
Affiliation  KLE University 
Address  Department of Periodontics KLE VK Institute of Dental Sciences, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  8074821125  
Fax    
Email  sk.shahanaz21@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neelamma Shetti 
Designation  Reader 
Affiliation  KLE University 
Address  Department of Periodontics, KLE VK Institute of Dental Sciences, Nehru Nagar,Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  7795447015  
Fax    
Email  neelushetti1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shahanaz Shaik 
Designation  Postgraduate 
Affiliation  KLE University 
Address  Department of periodontics, KLE VK Institute of Dental Sciences, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  8074821125  
Fax    
Email  sk.shahanaz21@gmail.com  
 
Source of Monetary or Material Support  
KLE VK Institute Of Dental Sciences, nehru nagar, Belagavi-590010 Karnataka 
 
Primary Sponsor  
Name  Dr Shahanaz Shaik 
Address  KLE VK Institute Of Dental Sciences 
Type of Sponsor  Other [Self funded] 
 
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 Shahanaz Shaik  Department of Periodontics  KLE VK Institute Of Dental Sciences, Nehru nagra, Belagavi-590010
Belgaum
KARNATAKA 
8074821125

sk.shahanaz21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional reaserch and ethics comittee KLE VKIDS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  class-1 gingival recession 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Macrosurgery  Macro surgical technique using conventional instruments for the treatment of gingival recession using coronally advanced flap and PRF  
Intervention  Microsurgery  Microsurgical technique using microsurgical loupes and instruments for treatment of gingival recession using coronally advanved flap and PRF  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Age group of 18-50 years.
Subjects with Miller’s class I gingival recession.
Patients having good systemic health.
Teeth with no radiographic signs of bone loss.
 
 
ExclusionCriteria 
Details  Pregnant or lactating women.
Systemic disease affecting periodontal treatment outcome.
Use of immunosuppressive agents.
Patients on antibiotics or anti-inflammatory drugs in the past 3 months.
Current and former smokers.
History of periodontal surgery in that area in the past 6 months.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Visual analog scale (VAS)
Healing index (HI)
Gingival index (GI)
Height of gingival recession (HGR)
Probing depth (PD)
Clinical attachment level (CAL)
Width of keratinized tissue (WKT)
Thickness of keratinized tissue (TKT)
 
baseline,1 month,3 months
 
 
Secondary Outcome  
Outcome  TimePoints 
Patient satisfaction, overall ease of performing the surgery  baseline,1 month,3 months
 
 
Target Sample Size   Total Sample Size="22"
Sample Size from India="22" 
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)   29/03/2024 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   no 
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 displacement of the gingival margin apical to

  the cemento - enamel junction resulting in exposure of the root surface causing sensitivity and root caries.

    Several procedures have been proposed for the treatment of gingival

recession in order to restore the periodontium to a healthy, efficient and aesthetic state.

   Coronally advanced flap procedure is one among them, which is based on the            coronal shift of adjacent soft tissues on to the exposed root surface.

The conditions required to perform the coronally advanced flap are the presence of keratinized tissue of an adequate height and thickness located apical to the exposed root surface.

In order to more predictably re-establish a new connective tissue attachment over a denuded root surface, the coronally advanced flap procedure may have to be combined with the use of a barrier according to the principles of the guided tissue regeneration (GTR).

Platelet concentrates like platelet rich plasma –PRP and platelet rich fibrin-PRF, act as key mediators and promotes wound healing, tissue repair as well as tissue regeneration.

Incorporation of microsurgical loupes along with specifically designed microsurgical instruments for periodontal plastic surgery provides better illumination and adequate magnification to increase the precision of a surgeon’s surgical skill. Thus, microsurgical techniques were developed to minimize tissue trauma and allow primary wound closure in the most desirable manner.

The present study will be undertaken to compare the clinical efficacy of microsurgical and macrosurgical techniques using Coronally advanced flap and Platelet rich fibrin for  the treatment of Miller’s class I  gingival recessions.

 


 
Close