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
|
|
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
|
|
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. |