| CTRI Number |
CTRI/2024/05/068051 [Registered on: 29/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to evaluate the gum thickness in palate using 3D digital software |
|
Scientific Title of Study
|
3 Dimensional digital analysis as a potential diagnostic pre-requisite for palatal mucosal harvest-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 |
Dr N V S Sruthima G |
| Designation |
Professor |
| Affiliation |
Vishnu Dental College |
| Address |
Block 2,Room No 7,Department of Periodontics, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9492293808 |
| Fax |
|
| Email |
sruthima@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr G Laxmi Kavya |
| Designation |
Postgraduate student |
| Affiliation |
Vishnu dental college |
| Address |
Block 2,Room No 7,Department of Periodontics, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8919125279 |
| Fax |
|
| Email |
glakshmikavya1997@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G Laxmi Kavya |
| Designation |
Postgraduate student |
| Affiliation |
Vishnu dental college |
| Address |
Block 2,Room No 7,Department of Periodontics, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8919125279 |
| Fax |
|
| Email |
glakshmikavya1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College, Vishnupur, Bhimavaram-534202, West Godavari District, Andhra Pradesh, India |
|
|
Primary Sponsor
|
| Name |
Dr G Laxmi Kavya |
| Address |
Block 2 Room No.7 Department of Periodontics Vishnu Dental College Vishnupur bhimavaram |
| 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 G Laxmi Kavya |
Vishnu Dental College |
Block 2,Romm No 7,Department of Periodontics, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH |
08919125279
glakshmikavya1997@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| 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 periodontally healthy full maxillary dentition (except for third molars)
3.Systemically healthy patients
|
|
| ExclusionCriteria |
| Details |
1.Patients with a history of any disease or surgery in the palate or tuberosity,
2.presence of any dental appliances in the upper arch,
3.previous orthodontic treatment,
4.extracted or congenitally missing premolars,
5.patients using medication that would affect the periodontal soft tissue,
6.malposition, or malalignment of the maxillary posterior teeth
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to measure palatal mucosal thickness and assess the location of greater palatine foramen |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assess the location of greater palatine foramen |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "32"
Final Enrollment numbers achieved (India)="32" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/06/2024 |
| Date of Study Completion (India) |
10/10/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
The aim of this study is to evaluate the accuracy of assessment of palatal mucosal thickness and determination of location of GPF using 3D digital analysis.A total of 30 patients were selected from out patient department of Periodontology.Vishnu Dental College,Bhimavaram.Assessment of greater palatine foramen location will be done using CBCT.Measurement of palatal mucosal thickness will be done from premolar to molar region in direct and digital technique. Direct technique:Transgingival probing analysis will be done to assess palatal mucosal thickness using endodontic files and digital vernier calliper’s.Palatal mucosal thickness will be assessed using CBCT. Image reconstruction for visual analysis will be performed by the ONDEMAND software.The data will be analysed individually for all the patients.There is no conflict of intrest. |