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CTRI Number  CTRI/2023/11/059897 [Registered on: 16/11/2023] Trial Registered Prospectively
Last Modified On: 15/11/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Gum surgery after clip treatment for lowering gums 
Scientific Title of Study   Enhancing Root Coverage and Aesthetic Outcomes in Isolated Gingival Recession Using Orthodontic Intervention and Lateral Closed Tunnel Technique: An Interdisciplinary prospective Case Series 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Neelima Katti 
Designation  Assistant Professor 
Affiliation  SCB Dental College and Hospital 
Address  Narayan mishra lane, mahtab road
Narayan mishra lane, mahtab road
Cuttack
ORISSA
753012
India 
Phone    
Fax    
Email  kattineelima@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Devapratim Mohanty 
Designation  Assistant professor 
Affiliation  SCB dental college and Hospital 
Address  Narayan mishra lane, mahtab road
Narayan mishra lane, mahtab road
Cuttack
ORISSA
753012
India 
Phone  9337613446  
Fax    
Email  kattineelima@gmail.com  
 
Details of Contact Person
Public Query  
Name  Devapratim Mohanty 
Designation  Assistant professor 
Affiliation  SCB dental college and Hospital 
Address  Narayan mishra lane, mahtab road
Narayan mishra lane, mahtab road

ORISSA
753012
India 
Phone  9337613446  
Fax    
Email  kattineelima@gmail.com  
 
Source of Monetary or Material Support  
SCB Dental College and Hospital 
 
Primary Sponsor  
Name  SCB Dental College and Hospital, Cuttack  
Address  SCB Dental College and Hospital, Cuttack Mangalabag, Cuttack, odisha  
Type of Sponsor  Government medical college 
 
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 
DrNeelima Katti  scb dental college and hospital  Mangalabag Cuttack ORISSA
Cuttack
ORISSA 		 9337613446

kattineelima@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics Committee, SCB Dental College and Hospital, Cuttack   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K051||Chronic gingivitis, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Periodontal surgery  Lateral closed tunnel technique will be performed in patients after completing orthodontic tooth correction. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Mandibular single incisor recession (Miller’s class I, II, and III and/or Cairo’s RT-1, RT-2) on the labial surface post orthodontic treatment.
2. All subjects had a healthy periodontal status with full mouth plaque score (FMPS)18 and full mouth bleeding score (FMBS) < 15%.  
 
ExclusionCriteria 
Details  patients with any systemic disease or under bone metabolism altering medications, pregnancy, severe malocclusion, severe periodontal disease with associated bony defects, tobacco usage, GR associated with caries or non-carious cervical lesions.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
recession depth, recession width, avascuar exposed root surface area  6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Aesthetic outcome using root surface esthetic score (RES) as given by Cairo et  6 months 
 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   23/11/2023 
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identification.

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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 [kattineelima@gmail.com].

  6. For how long will this data be available start date provided 08-06-2024 and end date provided 08-06-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Gingival recession (GR) in malposed tooth in association with bone dehiscence and/or fenestration poses a challenge for successful root coverage treatment. 20 patients with GR defects post orthodontic correction of  tooth malposition will be treated using a ateral closed tunnel technique (LCT). The primary parameters of recession depth, recession width, avascular root surface area will be measured before and after periodontal surgery. The secondary outcomes of aesthetic score as measured by root coverag esthetic score given by Cairo et al will be checked at the end of 6 months.

 
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