FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/11/076380 [Registered on: 08/11/2024] Trial Registered Prospectively
Last Modified On: 07/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Compare and evaluate the effects of Advanced-PRF and A-PRF incorporated with vitamin c on gingival thickness during periodontal therapy : A Randomized Clinical Control Trial 
Scientific Title of Study   Comparative evaluation of effects of Advanced-PRF (A-PRF) and A-PRF incorporated with Ascorbic Acid on Gingival Thickness during Periodontal Pocket Therapy in patients with Thin Gingival Biotype: A Randomized Clinical Control 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 Diksha Aswekar  
Designation  Post Graduate student 
Affiliation  Goa Dental College and Hospital Bambolim 
Address  Department no 2 Periodontics, Goa Dental college and Hospital, Bambolim, 403202 Goa India

North Goa
GOA
403202
India 
Phone  9049368402  
Fax    
Email  aswekardiksha10@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR James Samuel 
Designation  Professor and Head of Department (PG Guide) 
Affiliation  Goa Dental College and Hospital Bambolim 
Address  Department no 2 Periodontics, Goa Dental college and hospital, Bambolim, 403202 Goa, India

North Goa
GOA
403202
India 
Phone  9822151608  
Fax    
Email  jamessamueldental@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Diksha Aswekar  
Designation  Post Graduate student 
Affiliation  Goa Dental College and Hospital Bambolim 
Address  Department No 2 Periodontics, Goa Dental college and Hospital, Bambolim, 403202 Goa India

North Goa
GOA
403202
India 
Phone  9049368402  
Fax    
Email  aswekardiksha10@gmail.com  
 
Source of Monetary or Material Support  
Goa Dental College and Hospital department no 2 periodontics, Bambolim 403202 Goa India 
 
Primary Sponsor  
Name  Dr Diksha Aswekar  
Address  Goa Dental College and Hospital Department no 2 Periodontics, Bambolim 403202 Goa India 
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 
Dr Diksha Aswekar  Goa Dental college and hospital  Department No 2 Periodontics, Bambolim Goa
North Goa
GOA 
9049368402

aswekardiksha10@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Goa Dental College and Hospital Institutional Ethics committe  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 
Comparator Agent  control group (Group A) -open flap debridement alone   Gingival thickness will be assessed by periodontal probe visibility. If the probe is detectable through the marginal gingiva, the gingival biotype will be categorized as “thin”. No visibility of the probe will be defined as “thick”.Following which the accurate measurements was taken with help of vernier calliper. After 6–8 weeks of phase I therapy, an adequate local anaesthesia will be administered following aseptic precautions. A full-thickness mucoperiosteal flap will be reflected, using kirkland flap technique , thorough debridement will be done using Gracey curettes and the flap was sutured using 3-0 catgut suture and covered with coe-pack  
Intervention  Test Group (group c) - open flap debridement + placement of A-PRF augmented with ascorbic acid   Gingival thickness will be assessed by periodontal probe visibility. If the probe is detectable through the marginal gingiva, the gingival biotype will be categorized as “thin”. No visibility of the probe will be defined as “thick”.Following which the accurate measurements was taken with help of vernier calliper. After 6–8 weeks of phase I therapy, an adequate local anaesthesia will be administered following aseptic precautions. A full-thickness mucoperiosteal flap will be reflected, using kirkland flap technique , thorough debridement will be done using Gracey curettes. A-PRF membrane will be prepared by collecting 10ml of patients blood before centrifugation 100mg of ascorbic acid was added to achieve a concentration of 250mcg/ml and then centrifuged at 1200rpm and the fibrin clot was separated from RBC base and the membrane thus formed was placed under the flap and sutured using 3-0 catgut suture and covered with coe-pack  
Intervention  Test grpup (group B)- Open flap debridement + placement of A-PRF membrane   Gingival thickness will be assessed by periodontal probe visibility. If the probe is detectable through the marginal gingiva, the gingival biotype will be categorized as “thin”. No visibility of the probe will be defined as “thick”.Following which the accurate measurements was taken with help of vernier calliper. After 6–8 weeks of phase I therapy, an adequate local anaesthesia will be administered following aseptic precautions. A full-thickness mucoperiosteal flap will be reflected, using kirkland flap technique , thorough debridement will be done using Gracey curettes. A-PRF membrane will be prepared by collecting 10ml of patients blood and centifuged at 1200rpm and the fibrin clot was separated from RBC base and the membrane thus formed was placed under the flap and sutured using 3-0 catgut suture and covered with coe-pack  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Adult male and female patients in age group of 20-55 years
2.Pocket probing depth more than 5mm in anterior Teeth
3.Gingival thickness less than 1mm
4.Horizontal bone loss

 
 
ExclusionCriteria 
Details  1.Pregnancy and lactation
2.Smokers and tobacco users
3.Hypertension
4.Diabetes
5.Other systemic disorders
6.Vertical/angular bone loss
7.Grade 2 mobile teeth
8.Patients who are unwilling to participate in the study
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Alternation 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
gingival thickness, pocket probing depth  baseline, 3 months , 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
recession depth, keratinized tissue width, relative attachment level, plaque index, gingival index  baseline, 3 months, 6 months 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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)   18/11/2024 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Periodontitis is an infectious disease that culminates in inflammation within the soft tissues surrounding the teeth causing progressive bone loss. Periodontal surgery as part of the treatment of periodontal disease is mainly performed:

1) To gain access to diseased areas for adequate cleaning;

2) To achieve pocket reduction or elimination; and

3) To restore the periodontal tissues lost through the disease; i.e., a new attachment formation or periodontal regeneration.

 

To accomplish this goal of periodontal therapy, a number of surgical procedures have been advocated throughout the years.

Surgical debridement is a common procedure for teeth with deep periodontal pockets and horizontal bone loss. Surgical debridement with flap repositioning may often result in gingival recession which is seen due to lack of bone support for the flap, thin gingival tissue with limited blood supply and shrinkage of flap.

The gingival thickness is a significant predictor of clinical outcome of periodontal surgeries. A thick gingival biotype is a requisite for good periodontal health. It has important role in resisting trauma and subsequent gingival recession.

The term "gingival biotype" refers to the morphological characteristics of the gingiva and the tooth, whereas the terms "periodontal biotype," "periodontal morphotype," "gingival morphotype," and "gingival phenotype" refer to the clinical variations in the gingival thickness (GT) and keratinized tissue width (KTW), as well as other characteristics, such as bone morphotypes, tooth shape, and, morphological characteristics of the gingiva and the periodontium

 
Close