| CTRI Number |
CTRI/2025/07/091394 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
21/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
comparison of conventional and digital dental impressions for upper jaw borders |
|
Scientific Title of Study
|
Evaluation of trueness and precision in peripheral border extenstions of maxillary edentulous arch with conventional and digital impressions a cross sectional study |
| 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 Aisha shaikh |
| Designation |
postgraduate |
| Affiliation |
Bapuji dental college and hospital |
| Address |
Department of prosthodontics room number 7 bapuji dental college and hospital davangere karnataka 577004
Department of prosthodontics room number 7 bapuji dental college and hospital davangere karnataka 577004
Davanagere
KARNATAKA
577004
India |
| Phone |
08296205046 |
| Fax |
|
| Email |
aishashaikh532@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR PAVAN KUMAR K R |
| Designation |
PROFESSOR |
| Affiliation |
BAPUJI DENTAL COLLEGE |
| Address |
Department of prosthodontics room number 7 bapuji dental college and hospital davangere karnataka 577004
Department of prosthodontics room no 7 bapuji dental college and hospital davangere karnataka 577004
Davanagere
KARNATAKA
577004
India |
| Phone |
9738416552 |
| Fax |
|
| Email |
drpavankumarkr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr pavan kumar k r |
| Designation |
Professor |
| Affiliation |
BAPUJI DENTAL COLLEGE |
| Address |
Department of prosthodontics bapuji dental college and hospital davangere karnataka 577004
Department of prosthodontics bapuji dental college and hospital davangere karnataka 577004
Davanagere
KARNATAKA
577004
India |
| Phone |
9738416552 |
| Fax |
|
| Email |
drpavankumarkr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Aisha shaikh bapuji dental college and hospital davangere karnataka 577004 |
|
|
Primary Sponsor
|
| Name |
Individual dr Aisha Shaikh |
| Address |
Department of prosthodontics room no 7 bapuji dental college and hospital davangere karnataka 577004 |
| Type of Sponsor |
Other [investigator] |
|
|
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 pavan kumar |
bapuji dental college and hospital |
department of prosthodontics room number 7 2nd floor bapuji dental college and hospital davangere 577004
Davanagere
KARNATAKA |
9738416552
drpavankumarkr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| the INSTITUTIONAL REVIEW BOARD bapuji dental college and hospital davangere karnataka |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
completely edentulous maxilla
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
conventional impression technique |
conventional impression technique for recording peripheral border extensions of maxillary edentulous arch using custom trays border molding and scanning duration at baseline |
| Intervention |
digital impressions |
scanning patients maxillary edentulous arch using intraoral scanner duration at baseline |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Previous complete denture wearer patient with mean age of 60-70 years.
2 Completely edentulous maxillary arch, regardless of the condition in the mandibular arch.
3 Maxillary edentulous arch having well rounded ridge form with adequate height and width.
|
|
| ExclusionCriteria |
| Details |
1 Patients with recent extraction, abused mucosa due to ill-fitting dentures.
2 Patients with severe atrophic maxillary ridges with inadequate ridge height and width.
3 Patients with residual ridges having severe bony or soft tissue undercuts that require preprosthetic rehabilitation.
4 Patients with hypertrophic and flabby tissue.
5 Patients with maxillofacial defect.
6 Patients with deep and wide palatal vault.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate and compare trueness and precision of peripheral border extensions of maxillary edentulous arch recorded using conventional impression techniques and digital scanning methods |
baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to asses & compare time efficiency patient comfort & clinician satisfaction associated with conventional & digital impression techniques for recording peripheral border extensions in maxillary edentulous arches |
baseline |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
02/08/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
since complete denture have to be fabricated using conventional methods as border molding cannot be acheved digitally i am going to evaluate trueness and precision of perpheral extensions of completely edentulous maxillary arches using conventional and digital methods
|