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CTRI Number  CTRI/2025/08/092486 [Registered on: 06/08/2025] Trial Registered Prospectively
Last Modified On: 05/08/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Diagnostic accuracy trial 
Study Design  Other 
Public Title of Study   Assessment of gum height in missing area of teeth using CBCT and clinical method 
Scientific Title of Study   Applicability of CBCT in assessing crestal soft tissue height among adults: A diagnostic accuracy 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 Souparnika M Kulkarni 
Designation  PG student 
Affiliation  KVG Dental College and Hospital 
Address  Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327

Dakshina Kannada
KARNATAKA
574327
India 
Phone  8050512662  
Fax    
Email  kullkarnisouparnika@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shivananda H 
Designation  Associate Professor 
Affiliation  KVG Dental College and Hospital 
Address  Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327

Dakshina Kannada
KARNATAKA
574327
India 
Phone  9900794769  
Fax    
Email  shivanand_perio@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Shivananda H 
Designation  Associate Professor 
Affiliation  KVG Dental College and Hospital 
Address  Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327


KARNATAKA
574327
India 
Phone  9900794769  
Fax    
Email  shivanand_perio@yahoo.co.in  
 
Source of Monetary or Material Support  
KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327 
 
Primary Sponsor  
Name  Dr Souparnika M Kulkarni 
Address  Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327 
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 Souparnika M Kulkarni  KVG Dental College and Hospital  Room number 11 Department of Periodontology KVG Dental College and Hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India Pincode 574327
Dakshina Kannada
KARNATAKA 
8050512662

kullkarnisouparnika@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KVG Dental College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Systemically healthy patients with age group between 18-50 years
Subjects with partially edentulous area who are undergoing CBCT
 
 
ExclusionCriteria 
Details  Patients had soft tissue graft surgery at the edentulous site before taking CBCT
Patients under medical conditions or were taking medications that can affect bone or soft tissue wound healing, such as uncontrolled diabetes mellitus or osteoporosis, or using bisphosphonates.
Pregnant and lactating women.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the efficiency of crestal soft tissue measurement using CBCT and clinical method  Baseline 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate the measurement of crestal soft tissue height using CBCT.
To evaluate the measurement of crestal soft tissue height using clinical method.
 
Baseline 
 
Target Sample Size   Total Sample Size="8"
Sample Size from India="8" 
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)   30/09/2025 
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 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  

Crestal soft tissue height refers to the vertical measurement of the soft tissue covering the alveolar crest—the highest point of the alveolar bone surrounding natural teeth or dental implants. This dimension encompasses the combined thickness of the epithelial and connective tissue layers at the crest.

     Various methods are involved to measure crestal soft tissue height, some of them are traditional clinical methods such as probing and direct visualization, are commonly employed to assess soft tissue thickness. However, these techniques have inherent limitations, including variability in probing pressure, tissue compression, and operator-dependent inconsistencies, which can lead to unreliable measurements.

The advancement of cone-beam computed tomography (CBCT) in radiological imaging offers a non-invasive and highly accurate visualization of anatomical structures. It has become particularly valuable in dentistry due to its superior resolution and comparatively lower radiation exposure.

CBCT is now widely used for assessing jawbone density and dimensions before surgical procedures.

Initially developed for imaging hard maxillofacial tissues, CBCT has also been utilized in recent decades for analyzing soft tissues in the facial region. Research has demonstrated that CBCT serves as an accurate and non-invasive technique for soft maxillofacial tissue imaging.

Despite its advantages, the accuracy of CBCT in measuring soft tissue parameters compared to traditional clinical methods remains underexplored. Understanding the comparative effectiveness of these techniques is essential to establish standardized protocols for soft tissue assessment. This study aims to evaluate the accuracy of CBCT versus clinical methods in measuring crestal soft tissue height. The findings could lead to improved diagnostic precision and better clinical decision-making in implantology and periodontology.

 

 

 

 

 
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