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CTRI Number  CTRI/2021/04/032813 [Registered on: 13/04/2021] Trial Registered Prospectively
Last Modified On: 20/01/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   gums depigmentation procedure 
Scientific Title of Study   comparative evaluation of de-epithelization techniques for gingival depigmentation with non-eugenol periodontal dressing-A split-mouth randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SWET NISHA 
Designation  Assistant professor 
Affiliation  Haldia Institute Of Dental Sciences and Research 
Address  Department of Periodontology Haldia Institute of dental sciences and research division-Dentistry haldia
Department of Periodontology Haldia Institute of dental sciences and research division-Dentistry haldia banbishnupur,balughata
Medinipur
WEST BENGAL
721645
India 
Phone  07595800724  
Fax    
Email  swetnisha1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  SWET NISHA 
Designation  Assistant professor 
Affiliation  Haldia Institute Of Dental Sciences and Research 
Address  Department of Periodontology Haldia Institute of dental sciences and research division-Dentistry
Department of Periodontology Haldia Institute of dental sciences and research division-Dentistry banbishnupur,balughata
Medinipur
WEST BENGAL
721645
India 
Phone  07595800724  
Fax    
Email  swetnisha1@gmail.com  
 
Details of Contact Person
Public Query  
Name  SWET NISHA 
Designation  Assistant professor 
Affiliation  Haldia Institute Of Dental Sciences and Research 
Address  Department of Periodontology Haldia Institute of dental sciences and research division-Dentistry
Department of Periodontology Haldia Institute of dental sciences and research division -Dentistry banbishnupur balughata
Medinipur
WEST BENGAL
721645
India 
Phone  07595800724  
Fax    
Email  swetnisha1@gmail.com  
 
Source of Monetary or Material Support  
Department of Periodontology Haldia Institute of dental sciences and research division-Dentistry  
 
Primary Sponsor  
Name  Swet Nisha 
Address  Department of Periodontology,Haldia Institute Of Dental Sciences and Research,Haldia 
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 
Swet Nisha  Haldia Institute of dental sciences and research  Department of Periodontology Haldia Institute of dental sciences and research division-Dentistry banbishnupur,balughata
Medinipur
WEST BENGAL 		 07595800724

swetnisha1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Haldia institute of dental sciences and research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  smokers 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Depigmentation techniques smokers and non smokers  both the groups laser ,electrocautery and scapel method of depigmentation will be performed 
Intervention  Gingival depigmentation technique   Gingival depigmentation technique using laser,electrocautery and scapel method. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Participants with esthetic concern of gingiva.
smokers 
 
ExclusionCriteria 
Details  participants having systemic diseases like hypertension,diabetes mellitus
pregnant and lactating mother 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate effect of laser ,scapel and electrocautery method in gingival healing among smokers and non smokers.  1 week,1 month,3 month,6 month 
 
Secondary Outcome  
Outcome  TimePoints 
To determine repigmentation after surgical depigmentation among smokers and non-smokers.  3 and 6 months post operative  
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/04/2021 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [swetnisha1@gmail.com].

  6. For how long will this data be available start date provided 15-05-2021 and end date provided 01-05-2021?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   Gingival depigmentation procedures are routine periodontal surgical procedures.However newer techniques and advances makes it difficult to determine and chose the correct treatment plan.this study will help in assessing surgical procedures like laser,electrocautery and scapel method in terms of healing ,pain ,post operative complications and repigmentation. 
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