| 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
|
|
|
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
|
|
|
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.
|