| CTRI Number |
CTRI/2025/09/094837 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A trial study which will involve comparing diagnosis risk assessment and recall interval by clinician and AI backed model to check its accuracy |
|
Scientific Title of Study
|
Pilot Diagnostic Accuracy Study of PerioSmart for Periodontitis Staging, Grading, Risk Assessment & SPT protocol in a multicentric study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aruna Nautiyal Maithani |
| Designation |
Reader |
| Affiliation |
ITS Dental college,Ghaziabad |
| Address |
Department of Periodontology and Oral Implantology Room number 5 Delhi Merut Road Muradnagar Ghaziabad Uttar Pradesh 201206
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
09845680885 |
| Fax |
|
| Email |
arunamaithani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aruna Nautiyal Maithani |
| Designation |
Reader |
| Affiliation |
ITS Dental college,Ghaziabad |
| Address |
Department of Periodontology and Oral Implantology Room number 5 Delhi Merut Road Muradnagar Ghaziabad Uttar Pradesh 201206
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
09845680885 |
| Fax |
|
| Email |
arunamaithani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aruna Nautiyal Maithani |
| Designation |
Reader |
| Affiliation |
ITS Dental college,Ghaziabad |
| Address |
Department of Periodontology and Oral Implantology Room number 5 Delhi Merut Road Muradnagar Ghaziabad Uttar Pradesh 201206
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
09845680885 |
| Fax |
|
| Email |
arunamaithani@gmail.com |
|
|
Source of Monetary or Material Support
|
| ITS dental college NH 34 Ghaziabad Asalat nagar Uttar Pradesh 201206 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
Not Applicable |
| Type of Sponsor |
Other [Self funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aruna Nautiyal Maithani |
ITS Dental college |
Room no 5 Department of periodontology and oral implantology NH 34 Ghaziabad Asalat Nagar Uttar Pradesh 201206
Ghaziabad
UTTAR PRADESH |
09845680885
dr.arunanautiyal@its.edu.in |
| Dr Sonali Singh |
Kalka Dental college |
Room number 4 Department of Perioodntology & oral Implantology
Bypass Near Partapur Flyover Royal Kunj Partapur Meerut UP 250006
Meerut
UTTAR PRADESH |
08840280133
drsonalisingh99@gmail.com |
| Dr Saurav Singh |
Santosh Dental College |
Room no. 9 Department of periodontology and oral implantology Sector 12 Block H Pratap Vihar Uttar Pradesh 201009
Ghaziabad
UTTAR PRADESH |
09826483854
drsauravsingh4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 3 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
| Institutional ethics committee |
Submittted/Under Review |
| Institutional ethics committee |
Submittted/Under Review |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Periodontitis Patients |
|
| ExclusionCriteria |
| Details |
Patients on periodontal treatment in the past 6 months
Systemic conditions severely affecting the periodontium
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Agreement in staging/grading/risk assessment & SPT recall |
Baseline at start and end of session |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Agreement in risk scores
Agreement in SPT recall
Mean SUS score
Time taken per diagnosis (seconds).
|
baseline at start & end of session |
|
|
Target Sample Size
|
Total Sample Size="328"
Sample Size from India="328"
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)
|
26/09/2025 |
| 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="2"
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
|
Step 1 Patient Recruitment & Consent Eligible participants will be screened and recruited Study objectives will be explained and informed consent will be obtained before the study Step 2 Gold Standard Assessment Full mouth periodontal charting (probing depth CAL bleeding mobility furcation) will be performed Full mouth radiographs will be taken Periodontal diagnoses (Stage & Grade) will be established by consensus of experienced periodontists Step 3 Digital Data Entry Clinical and radiographic findings will be entered into the PerioSmart web tool Step 4 Automated Output from PerioSmartDx The tool will generate AAP 2017 Stage AAP 2017 Grade Periodontal Risk (Lang & Tonetti model) Recall schedule (Merin’s protocol) Step 5 Diagnostic Accuracy Assessment PerioSmartDx outputs will be compared with gold standard diagnoses Agreement and disagreement will be recorded Step 6 Usability Assessment Clinicians who use the tool will complete the System Usability Scale (SUS) questionnaire Usability feedback will be collected and analyzed |