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CTRI Number  CTRI/2024/01/061155 [Registered on: 05/01/2024] Trial Registered Prospectively
Last Modified On: 01/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   A study to compare the results of two different gum graft techniques in treating receding gums 
Scientific Title of Study   Clinical outcomes following gingival unit graft and free gingival graft in the management of Miller’s class I and II gingival recession -A hospital based comparative prospective cohort study  
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 Lilly Priya R 
Designation  Post graduate student  
Affiliation  Government Dental College, Kozhikode 
Address  No.38, Department of Periodontics, Government Dental College, Government Medical College P.O, Kozhikode, Kerala-673008

Kozhikode
KERALA
673008
India 
Phone  7736009263  
Fax    
Email  lillypriyaravikumar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harikumar K 
Designation  Professor and Head 
Affiliation  Government Dental College, Kozhikode 
Address  No.38, Department of Periodontics, Government Dental College, Government Medical College P.O, Kozhikode, Kerala-673008

Kozhikode
KERALA
673008
India 
Phone  9847128617  
Fax    
Email  harisindhu@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Harikumar K 
Designation  Professor and Head 
Affiliation  Government Dental College, Kozhikode 
Address  No.38, Department of Periodontics, Government Dental College, Government Medical College P.O, Kozhikode, Kerala-673008

Kozhikode
KERALA
673008
India 
Phone  9847128617  
Fax    
Email  harisindhu@hotmail.com  
 
Source of Monetary or Material Support  
Government Dental College, Kozhikode,Kerala 
 
Primary Sponsor  
Name  Dr Lilly Priya R 
Address  No.38, Department of Periodontics, Government Dental College, Government Medical College P.O, Kozhikode, Kerala-673008 
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 Harikumar K  Government Dental College Kozhikode  No.38, Department of Periodontics, Government Dental College, Government Medical College P.O, Kozhikode, Kerala-673008
Kozhikode
KERALA 		 09847128617

harisindhu@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Government Dental College, Kozhikode  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  Nil   Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1) Age: 18-60 years
2) Systemically healthy patients
3) Patients with good oral hygiene maintenance
4) Miller’s class I and II gingival recession in maxillary and mandibular anterior teeth
5) Recession depth > 2mm 
 
ExclusionCriteria 
Details  1) Smokers
2) Endodontically treated teeth
3) Teeth with root surface restoration
4) Pregnant / lactating women
5) Previous history of surgical periodontal therapy in mandibular and maxillary anterior region.
6) Non-carious cervical lesions in the area of interest
7) Patients with Unstable Periodontitis
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
1) Vertical Recession Depth (VRD): Distance between the Cementoenamel Junction (CEJ) and the gingival margin in milli-meter (mm).
2) Mean root coverage (MRC): Mean obtained in both the groups. Expressed in percentage.
3) Keratinized Tissue Width (KTW): Distance between the gingival margin and the mucogingival junction in mm.
4) Keratinized Tissue Thickness (KTT): By probe transparency method in mm
 		 Baseline (T0) 1 week (T1) 1 month (T2)
3 months (T3) 6 months (T4) post-surgery  
 
Secondary Outcome  
Outcome  TimePoints 
1) Probing Depth (PD): Distance between the most apical part of the gingival margin and the bottom of the pocket in mm.
2) Clinical Attachment Loss (CAL): Distance between the CEJ and the bottom of the pocket in mm.
3) Recession Width (RW): Width of exposed root surface 1mm apical to the CEJ in mm.
4) Complete Root Coverage (CRC): Recorded when the post-operative gingival margin completely covers the CEJ.
 		 Baseline (T0) 1 week (T1) 1 month (T2)
3 months (T3) 6 months (T4) post-surgery  
 
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   N/A 
Date of First Enrollment (India)   11/01/2024 
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="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

CLINICAL OUTCOMES FOLLOWING GINGIVAL UNIT GRAFT AND FREE GINGIVAL GRAFT IN THE MANAGEMENT OF MILLER’S CLASS I AND II GINGIVAL RECESSION

-A HOSPITAL BASED COMPARATIVE PROSPECTIVE COHORT STUDY

I am conducting a hospital based prospective cohort study comparing the outcomes following gingival unit graft and free gingival graft in the Department of Periodontics, Govt. Dental College, Kozhikode. The study duration is 21 months from the date of ethical clearance. Patients coming to the outpatient department of Periodontics, Govt. Dental College, Kozhikode, Kerala for surgical treatment of Miller’s class I and II gingival recession are recruited. A total of 36 samples, 18 in each group will be selected from the Department of Periodontics, Govt. Dental College, Kozhikode. Primary outcomes variables are Vertical Recession Depth (VRD), Mean root coverage (MRC), Keratinized Tissue Width (KTW), Keratinized Tissue Thickness (KTT) at Baseline (T0), 1 week (T1), 1 month (T2), 3 months (T3) and 6 months (T4) post-surgery. 
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