| CTRI Number |
CTRI/2025/06/088857 [Registered on: 13/06/2025] Trial Registered Prospectively |
| Last Modified On: |
13/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Testing a new method for more accurate digital scans of full-mouth dental implants |
|
Scientific Title of Study
|
Accuracy of complete arch digital implant impressions with and without scan body splinting using modular chain - A clinical trail |
| 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 Parikeerthan Y P |
| Designation |
Post graduate student |
| Affiliation |
Bapuji dental college and hospital |
| Address |
Room no 7 department of prosthodontics and crown and bridge bapuji dental college and hospital Mcc B block Davangere - 577004 Davanagere KARNATAKA 577004 India |
| Phone |
9972935644 |
| Fax |
|
| Email |
parikeerthan@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Parikeerthan Y P |
| Designation |
Post graduate student |
| Affiliation |
Bapuji dental college and hospital |
| Address |
Room no 7 department of prosthodontics and crown and bridge bapuji dental college and hospital Mcc B block Davangere - 577004
KARNATAKA 577004 India |
| Phone |
9972935644 |
| Fax |
|
| Email |
parikeerthan@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sunitha N Shamnur |
| Designation |
Professor |
| Affiliation |
Bapuji dental college and hospital |
| Address |
Room no 7 department of prosthodontics and crown and bridge bapuji dental college and hospital Mcc B block Davangere - 577004 Davanagere KARNATAKA 577004 India |
| Phone |
9449822941 |
| Fax |
|
| Email |
shamnursunithan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bapuji dental college and hospital |
|
|
Primary Sponsor
|
| Name |
self |
| Address |
Room number 7 department of prosthodontics and crown and bridge bapuji dental college and hospital davangere |
| 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 Sunitha N Shamnur |
Bapuji dental college and hospital |
Department of prosthodontics and crown and bridge room number 7 Davanagere KARNATAKA |
9449822941
shamnursunithan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bapuji dental college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K081||Complete loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Modular E- Chain |
The patients intra oral scanning will be done by connecting the modular E - chain passively to the scan bodies |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with full arch implant placed with ISQ value greater then or equal to 60 |
|
| ExclusionCriteria |
| Details |
Patients with limited mouth opening |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accurate scanned data will be obtained by splinting |
Base line |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="6" Sample Size from India="6"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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="3" 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
|
This study aims to assess and compare the accuracy of complete arch digital implant impressions, both with and without the use of a modular E-chain for splinting scan bodies. In contemporary prosthodontics, precise implant impressions are crucial for the long-term success of implant-supported prostheses. Digital impression techniques using intraoral scanners offer advantages over traditional methods in terms of ease and accuracy. Splinting of impression copings or scan bodies is a recognized technique to enhance stability and accuracy, especially for complete arch impressions involving four or more implants. While various materials have been used for splinting, modular chains have emerged as a promising alternative due to their ease of use, stability, and ability to improve scanning reference points, overcoming limitations of traditional resins and dental floss. The study will involve patients visiting the Department of Oral Implantology. Patients meeting specific inclusion criteria, such as having full arch implants with an ISQ value greater than or equal to sixty, will be selected. Exclusion criteria include patients with limited mouth opening. The methodology involves three main steps: - Master Reference Model Preparation: A conventional impression will be taken, and a master cast will be created. This cast will be indirectly scanned using a laboratory scanner to generate a highly accurate Standard Tessellation Language (STL) file, serving as the master reference.
- Intraoral Scanning Procedure: Patients will undergo two intraoral scans using a Dentsply Sirona Primescan. First, scan bodies will be scanned without the modular E-chain. Second, the scan bodies will be passively connected with the modular E-chain and then scanned. Two separate STL files will be obtained from these scans.
- Data Processing and Accuracy Assessment: All generated STL files (from scans with and without the modular E-chain) will be aligned with the master reference STL file using Geomagic Studio 12 software. The software will then be used to measure and compare the linear deviations in the x, y, and z axes (in micrometers) and angular deviations (in degrees) between the scanned models and the master reference.
The primary objective is to determine if there is a significant difference in linear and angular deviation between digital implant impressions taken with and without modular E-chain splinting. The research hypothesis anticipates a difference, while the null hypothesis states there will be no difference. An independent Student’s t-test will be used for statistical analysis, with a p-value less than 0.05 indicating statistical significance. The total sample size will be six patients, calculated based on previous research. |