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CTRI Number  CTRI/2023/10/058208 [Registered on: 03/10/2023] Trial Registered Prospectively
Last Modified On: 20/01/2025
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Measurement of the thickness of gums and bone using direct and digital technique 
Scientific Title of Study   Assessment and Correlation of periodontal phenotype using conventional direct and digital techniques-A cross-sectional analysis.  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chittabathina Poornima 
Designation  Post graduate Student 
Affiliation  Vishnu Dental College 
Address  Department of Periodontics and implantology, block-2, room no-7, Vishnu Dental College Vishnupur Bhimavaram West Godavari ANDHRA PRADESH India

West Godavari
ANDHRA PRADESH
534202
India 
Phone  99494977479  
Fax    
Email  poornimachittabathina999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr N V S Sruthima G 
Designation  Professor 
Affiliation  Vishnu Dental College 
Address  Department of periodontics and implantology, block-2, room no-7, Vishnu Dental College Vishnupur Bhimavaram West Godavari ANDHRA PRADESH India

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9492293808  
Fax    
Email  sruthima@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr N V S Sruthima G 
Designation  Professor 
Affiliation  Vishnu Dental College 
Address  Department of periodontics and implantology, block-2, room no-7, Vishnu Dental College Vishnupur Bhimavaram West Godavari ANDHRA PRADESH India

West Godavari
ANDHRA PRADESH
534202
India 
Phone  9492293808  
Fax    
Email  sruthima@gmail.com  
 
Source of Monetary or Material Support  
Department of Periodontics and Implantology Vishnu dental college Vishnupur Bhimavaram Pin-534202 west godavari Andhra pradesh 
 
Primary Sponsor  
Name  Chittabathina Poornima 
Address  Department of Periodontics and Implantology Vishnu Dental College Vishnupur Bhimavaram pin-534202 west godavari Andhra pradesh 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 Chittabathina Poornima  Vishnu Dental College  Department of periodontics and implantology, block-2, room no-7, Vishnupur, Bhimavaram PIN- 534202 West Godavari ANDHRA PRADESH
West Godavari
ANDHRA PRADESH 		 9494977479

poornimachittabathina999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,vishnu dental college  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K056||Periodontal disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Age – 20 to 50 years.
2.Patients with periodontal health(Intact periodontium and Reduced periodontium) 3.Systemically healthy patients. 
 
ExclusionCriteria 
Details  1.Patients with uncontrolled systemic diseases
2.Signs of gingivitis/gingival diseases that alter the size of gingiva. 3.Chronic smokers.
4.Presence of systemic conditions i.e.,Pregnancy,puberty and nutritional deficiencies.
5.Presence of traumatic occlusion.
6.Patients on drugs that can alter gingival and bone morphology.
7.Patients with any bone disorders.
8.Patients with infectious diseases (HIV, Hepatitis B or Hepatitis C) 9.Patients undergoing radiation therapy 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Gingival Thickness.
2.Bone Thickness. 		 1.Gingival Thickness will be measuring at 0 day.
2.Bone Thickness will be measuring at 0 day. 
 
Secondary Outcome  
Outcome  TimePoints 
NOT APPLICABLE  NOT APPLICABLE 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   N/A 
Date of First Enrollment (India)   04/10/2023 
Date of Study Completion (India) 27/03/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 27/03/2024 
Estimated Duration of Trial   Years="0"
Months="4"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

TITLE:

Assessment and Correlation of periodontal phenotype using conventional direct and digital techniques-A cross-sectional analysis.

Methodology:

  • Measurement of GT and BT will be done around 6 Teeth (irt 16,14,21,36,41,44) at 2 and 4 mm apical to crest of alveolar bone.

    • Transgingival probing analysis will be done to assess GT using endodontic files and digital vernier calliper’s for conventional direct technique.

      • BT will be assessed using CBCT

        • GT and BT will be assessed after registration between oral soft tissues obtained by Digital Intra-oral scanners (DIS) and hard tissue images generated by CBCT. 

    Source of the data:Patients attending Vishnu dental college.

 
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