| CTRI Number |
CTRI/2024/10/074847 [Registered on: 07/10/2024] Trial Registered Prospectively |
| Last Modified On: |
05/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare accuracy of multiple implant impressions in terms of trueness, precision and angle deviation in digital and splinted closed tray with splinted open tray impression method. |
|
Scientific Title of Study
|
Comparative Evaluation Of Accuracy in Terms of Trueness, Precision and Angle deviation of Multiple Implant Impressions in Digital and Splinted Closed Tray With Splinted Open Tray Impression Method: A Randomised Controlled Clinical Trial |
| 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 Rutuja Deshmukh |
| Designation |
Post Graduate Student |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. |
| Address |
104, First Floor, Department of Prosthodontics, Crown And Bridge,
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital
Hingna, Nagpur. Maharashtra, India
Nagpur
MAHARASHTRA
441110
India Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital
Hingna, Nagpur. Maharashtra, India
Nagpur
MAHARASHTRA
441110
India Nagpur MAHARASHTRA 441110 India |
| Phone |
7058228684 |
| Fax |
|
| Email |
deshmukh.rutuja24@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Krishankumar Lahoti |
| Designation |
Reader and PG Guide |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. |
| Address |
104, First Floor, Department of Prosthodontics, Crown And Bridge,
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital
Hingna, Nagpur. Maharashtra, India
Nagpur
MAHARASHTRA
441110
India Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital
Hingna, Nagpur. Maharashtra, India
Nagpur
MAHARASHTRA
441110
India Nagpur MAHARASHTRA 441110 India |
| Phone |
9763711501 |
| Fax |
|
| Email |
kk.lahoti@sdk-dentalcollege.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Dr Rutuja Deshmukh |
| Designation |
Post Graduate Student |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Hingna, Nagpur. |
| Address |
104, First Floor, Department of Prosthodontics, Crown And Bridge,
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital
Hingna, Nagpur. Maharashtra, India
Nagpur
MAHARASHTRA
441110
India Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital
Hingna, Nagpur. Maharashtra, India
Nagpur
MAHARASHTRA
441110
India
MAHARASHTRA 441110 India |
| Phone |
7058228684 |
| Fax |
|
| Email |
deshmukh.rutuja24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital
Hingna, Nagpur. Maharashtra, India
Nagpur
MAHARASHTRA
441110
India |
|
|
Primary Sponsor
|
| Name |
Dr Rutuja Deshmukh |
| Address |
104, First Floor, Department of Prosthodontics, Crown And Bridge,
Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital
Hingna, Nagpur. Maharashtra, India
Nagpur
MAHARASHTRA
441110
India |
| 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 Rutuja Deshmukh |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
104, Department Of
Prosthodontics, Crown
And Bridge, Swargiya
Dadasaheb Kalmegh
Smruti Dental College
and Hospital, Hingna,
Nagpur, Maharashtra
Nagpur
MAHARASHTRA Nagpur MAHARASHTRA |
7058228684
deshmukh.rutuja24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee- Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur 441110 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, (2) ICD-10 Condition: PCS||, (3) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
closed tray impression method |
it is a conventional implant impression method used to make implant impression. Closed tray impression copings will be used and will splint it with floss and BIS GMA resin to make impression. Cast will be poured using type IV gypsum and will be assessed after a day. |
| Intervention |
digital impression method |
intraoral scanner is used to make implant impression. Scan bodies will be fixed to implant and digital impression will be made |
| Comparator Agent |
splinted open tray impression method |
it is a conventional implant impression method used to make implant impression. open tray impression copings will be used and will splint it with floss and BIS GMA resin to make impression. Cast will be poured using type IV gypsum and will assessed after a day. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with the age group of ≥ 18 to 70 years.
2.Patients irrespective of gender will be selected.
3.Partially edentulous patient having unilaterally placed two or more implants.
4.Volunteer patients who agree to give informed consent will be considered
as individuals for the research.
|
|
| ExclusionCriteria |
| Details |
1.Patients requiring fixed implant prosthesis on single implant.
2.Patients having bilaterally placed single implants.
3.Completely edentulous patients.
4.Patients having a neuromuscular disorder. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) To evaluate the accuracy of multiple implant impression in terms of trueness, precision
and angle deviation using digital method.
2) To evaluate the accuracy of multiple implant impression in terms of trueness, precision
and angle deviation using splinted closed tray impression.
3) To evaluate the accuracy of multiple implant impression in terms of trueness, precision
and angle deviation using splinted open tray impression method. |
At first the accuracy of multiple implant impression
using digital method will be obtained.
secondly the accuracy of multiple implant impression
using splinted closed tray impression will be obtained.
Then the accuracy of multiple implant impression using splinted open tray impression method will be obtained.
The accuracy of the impression method will be assessed after a day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) To compare the accuracy in terms of trueness, precision & angle deviation of multiple
implant impression using digital & splinted closed tray impression with splinted open
tray impression method. |
The inter implant distance between two or more implant will be measured using
coordinate measuring machine in x, y & z axis of all the obtained casts.
Obtained data will be uploaded to the Software & accuracy will be evaluated &
compared within a week. |
|
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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)
|
21/10/2024 |
| 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="1" Months="6" Days="2" |
|
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
|
The objective of contemporary dentistry is to return patients to a state of normal
contour, function, comfort, aesthetics, speech, and health, whether it involves restoring
a single tooth or replacing multiple teeth. As the number of missing teeth increases in a
patient, achieving this goal becomes increasingly challenging. Osseointegrated Dental
implants have provided better treatment option for individuals who have lost their
teeth, serving as an alternative to traditional prostheses. The positioning of implants is
dictated by the anatomy of the remaining ridges. These implants have demonstrated
promising long-term outcomes for patients. Creating impressions is a fundamental aspect of prosthesis fabrication. The choice of
impression material and technique significantly impacts the fit of the prosthesis.
Accurately transferring the spatial relationships of implants from the oral cavity to the
master cast through the impression process is the initial and vital step to ensure a
passive fit of the implant framework. Various impression techniques are recommended to create a master cast ensuring the
passive fit of implant-supported prostheses. Two conventional methods include the
open tray method (Direct method /pick-up impression technique) and the closed tray
method (Indirect method /transfer impression technique). Conventional implant impression using elastomeric impression material have been a
standard procedure for fixed prosthodontics for a long time however, digital implant
impressions using intraoral scanners (IOS) are a comparatively recent but steadily
advancing technique. The utilization of intraoral scanners is on the rise, particularly for
implant-supported fixed dental prostheses. Intraoral scan bodies essentially function to
transfer the intraoral implant position to the digital model. Primary
Objectives:-
1) To evaluate the accuracy of multiple implant impression in terms of trueness, precision
and angle deviation using digital method.
2) To evaluate the accuracy of multiple implant impression in terms of trueness, precision
and angle deviation using splinted closed tray impression.
3) To evaluate the accuracy of multiple implant impression in terms of trueness, precision
and angle deviation using splinted open tray impression method. Method of measurement: The 36 candidates will be selected according to the inclusion and exclusion
criteria. Digital impression, splinted closed tray, splinted open tray impression and
will be made. Intraoral scanning will be done according to the
manufacturer’s instructions. Implant Impression of patients with partial
edentulous arch with two or more implants placed unilaterally will be made. Digital impression method: The scan bodies will be affixed to the implants. Intraoral scanning will be
performed according to the manufacturer’s instructions. Subsequently, a Standard Tessellation Language (STL) file will be generated from
the scan data. Finally, a model will be fabricated based on the digital scan using
3D printer. splinted open tray and closed tray impression coping will be used for respective impression techniques and it will be splinted using dental floss and BIS-GMA resin. The inter-implant distance between two or more implant will be measured using
coordinate measuring machine in x, y and z axis of all the obtained casts. Obtained data will be uploaded to the Software and accuracy will be evaluated and
compared. The series of operations will be performed on all combinations of the type IV
gypsum casts for open and closed tray impressions and digital model sets for each
patient. Obtained data will be evaluated and compared amongst the group based on
trueness, precision and angle deviation of every impression technique.
|