FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/06/069032 [Registered on: 18/06/2024] Trial Registered Prospectively
Last Modified On: 15/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical study to compare Enamel Matrix Derivative and Connective Tissue graft for correction of black triangles between teeth 
Scientific Title of Study   Efficacy of Enamel Matrix Derivative compared with Connective Tissue Graft using Minimally invasive surgical techniques in the treatment of shallow gingival recessions with black triangles- A double blinded randomized controlled 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 Harikumar K 
Designation  Professor and Head 
Affiliation  Kerala University of Health Sciences 
Address  Room No 38 Department of Periodontics Government Dental College Kozhikode

Kozhikode
KERALA
673008
India 
Phone  9847128617  
Fax    
Email  harisindhu@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Harikumar K 
Designation  Professor and Head 
Affiliation  Kerala University of Health Sciences 
Address  Room No 38 Department of Periodontics Government Dental College Kozhikode

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  Kerala University of Health Sciences 
Address  Room No 38 Department of Periodontics Government Dental College Kozhikode

Kozhikode
KERALA
673008
India 
Phone  9847128617  
Fax    
Email  harisindhu@hotmail.com  
 
Source of Monetary or Material Support  
Dr Harikumar K Professor and Head Department of Periodontics Government Dental College Kozhikode - 673008 
 
Primary Sponsor  
Name  Dr Harikumar K 
Address  Professor and Head Room No 38 Department of Periodontics Government Dental College Kozhikode, 673017, Kerala, 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 Harikumar K  Government Dental College, Kozhikode  Room No 38 Department of Periodontics
Kozhikode
KERALA 		 9847128617

harisindhu@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committe  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  Connective Tissue Graft   It is a autogenous soft tissue graft procured from the patients palate 
Intervention  Enamel Matrix Derivative  It consist of sterilized and lyophilized amelogenin fraction of porcine enamel matrix which is dissolved in propylene glycol alginate 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Buccal recession depth less than or equal to 3mm in the maxilla with associated papillary recession
2 patients maintaining good oral hygiene after phase 1 therapy
 
 
ExclusionCriteria 
Details  1 smokers
2 thin gingival biotypes
3 pregnant and lactating patients
4 patients with systemic disorders
5 patients who are under antibiotic or anti inflammatory therapy
6 patients with prosthetic crowns and restorations in the area of interest
7 non carious cervical lesions in the surgical site 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1 Gingival embrasure fill
2 Papillary height 		 baseline
1 month
3months
6months
1 year 
 
Secondary Outcome  
Outcome  TimePoints 
1 recession depth reduction
2 Keratinized tissue width
3 Keratinized tissue thickness
4 Complete root coverage
5 Mean root coverage
6 Bleeding on probing
7 Root coverage esthetic score
 		 baseline
1 month
3months
6months
1 year 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
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)   28/06/2024 
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 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   My study titled - Efficacy of Enamel Matrix Derivative compared with Connective Tissue Graft using Minimally Invasive surgical techniques in the treatment of shallow gingival recessions with black triangles- A double blinded randomized controlled trial is conducted in the Department of Periodontics, Government Dental College, Kozhikode, Kerala. It is a hospital based double blinded randomized controlled trial of  24 months duration  from the date of ethical clearance with a sample size of 20, 10 each in test and control group. Our primary outcome variables are gingival embrasure fill and increase in papillary height at baseline, 1 month, 3 months, 6 months and 1 year. 
Close