| CTRI Number |
CTRI/2026/03/106331 [Registered on: 16/03/2026] Trial Registered Prospectively |
| Last Modified On: |
10/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A study to evaluate the efficacy of intraoral scanners in diagnosis of gingival inflammation |
|
Scientific Title of Study
|
DIGITAL PERIODONTAL
DIAGNOSTICS: NON- INVASIVE EVALUATION OF GINGIVAL
INFLAMMATION WITH INTRAORAL SCANNERS. |
| 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 Shabana Ghantasala |
| Designation |
Postgraduate |
| Affiliation |
GSL DENTAL COLLEGE |
| Address |
Room no.10,Department of periodontics ,NH-16, Lakshmipuram, Rajamahendravaram (Rajahmundry), East Godavari District, Andhra Pradesh, 533296
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
7032855829 |
| Fax |
|
| Email |
shabanaghantasala@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Naga sai sowparnica naidu |
| Designation |
Senior lecturer |
| Affiliation |
GSL DENTAL COLLEGE |
| Address |
Room No.10,Department of periodontics, NH-16, Lakshmipuram, Rajamahendravaram (Rajahmundry), East Godavari District, Andhra Pradesh, 533296
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
9133941505 |
| Fax |
|
| Email |
nagasaisowpi@gamil.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shabana Ghantasala |
| Designation |
Postgraduate |
| Affiliation |
GSL DENTAL COLLEGE |
| Address |
Room no.10,Department of periodontics,NH-16, Lakshmipuram, Rajamahendravaram (Rajahmundry), East Godavari District, Andhra Pradesh, 533296
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
7032855829 |
| Fax |
|
| Email |
shabanaghantasala@gmail.com |
|
|
Source of Monetary or Material Support
|
| GSL DENTAL COLLEGE,NH-16, Lakshmipuram, Rajamahendravaram (Rajahmundry), East Godavari District, Andhra Pradesh, 533296 |
|
|
Primary Sponsor
|
| Name |
GSL DENTAL COLLEGE |
| Address |
NH-16, Lakshmipuram, Rajamahendravaram (Rajahmundry), East Godavari District, Andhra Pradesh, 533296 |
| Type of Sponsor |
Other [Private Dental College] |
|
|
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 Shabana Ghantasala |
GSL DENTAL COLLEGE AND HOSPITAL |
Room No.10,Department of periodontics,NH-16, Lakshmipuram, Rajamahendravaram (Rajahmundry), East Godavari District, Andhra Pradesh, 533296
East Godavari
ANDHRA PRADESH |
7032855829
shabanaghantasala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GSL DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic Generalised Gingivitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intraoral scanning |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 18-40 years and individuals with atleast 20 natural teeth, who are healthy and not under any medication |
|
| ExclusionCriteria |
| Details |
Patients who were smokers or tobacco users were excluded from the study. Individuals who were under medications known to affect gingival conditions were also excluded. Pregnant and lactating women were not included in the study. Additionally, patients who had undergone periodontal therapy within the previous six months were excluded to avoid any influence of recent treatment on gingival parameters. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Modified Gingival Index |
6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
01/05/2026 |
| 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 - NO
|
|
Brief Summary
|
Intraoral scanners (IOS) have revolutionized digital dentistry by providing non-invasive, high-resolution visualization of oral structures. Recent advancements suggest their potential application in periodontal diagnostics, particularly in assessing gingival inflammation. Traditional gingival evaluation methods rely on clinical indices such as the Gingival Index (GI) and Bleeding on Probing (BOP), which are subjective and invasive. IOS technology offers a promising alternative through optical data capture and colorimetric analysis, which can quantify subtle changes in gingival color and contour associated with inflammation.
The current proof-of-concept study aims to validate the feasibility of using intraoral scanners as a digital tool for non-invasive assessment of gingival inflammation. This aligns with the growing emphasis on chairside digital diagnostic systems, improving accuracy, reproducibility, and patient comfort. |