| 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
|
|
|
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
|
|
|
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 “thinâ€. No visibility of the probe will be defined as “thickâ€.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 “thinâ€. No visibility of the probe will be defined as “thickâ€.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 “thinâ€. No visibility of the probe will be defined as “thickâ€.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 | |