| CTRI Number |
CTRI/2025/12/099188 [Registered on: 16/12/2025] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Comparitive study |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare the Accuracy of Conventional and Digital Implant Impressions in Missing Teeth |
|
Scientific Title of Study
|
Assessment of accuracy in Conventional versus Digital Implant Level Impression Technique in Partially Edentulous Arches: A Comparative 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 J Soumya |
| Designation |
Post Graduate Student |
| Affiliation |
Faculty of Dental Sciences ,Ramaiah University of Applied Sciences |
| Address |
Department of Prosthodontics,Room no 4 ,1st floor,faculty of Dental sciences,Ramaiah University of Applied Sciences,NEW BEL Road
Bangalore KARNATAKA 560054 India |
| Phone |
7019451164 |
| Fax |
|
| Email |
jsoumya60@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Gayathri Devi S K |
| Designation |
Assistant Professor |
| Affiliation |
Faculty of Dental Sciences ,Ramaiah University of Applied Sciences |
| Address |
Department of Prosthodontics,Room no 4 ,1st floor,faculty of Dental sciences,Ramaiah University of Applied Sciences,NEW BEL Road
Bangalore KARNATAKA 560054 India |
| Phone |
9886762183 |
| Fax |
|
| Email |
gayathridevi@msruas.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Dr J Soumya |
| Designation |
Post Graduate Student |
| Affiliation |
Faculty of Dental Sciences ,Ramaiah University of Applied Sciences |
| Address |
Department of Prosthodontics,Room no 4 ,1st floor,faculty of Dental sciences,Ramaiah University of Applied Sciences,NEW BEL Road
Bangalore KARNATAKA 560054 India |
| Phone |
7019451164 |
| Fax |
|
| Email |
jsoumya60@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Prosthodontics,Room no 4,1st floor, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, New BEL Road, MSR Nagar, Bangalore, Karnataka, India, Pincode- 560054 |
|
|
Primary Sponsor
|
| Name |
Dr. J Soumya |
| Address |
Faculty of Dental Sciences, Ramaiah University of Applied Sciences, NEW BEL Road, Bengaluru, Karnataka, 560054 |
| 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 J Soumya |
Ramaiah Dental Hospital |
Department of Prosthodontics, Room no 4, 1st floor, Faculty of Dental Sciences, Ramaiah University of Applied Sciences,New BEL Road, MSR Nagar Banglore Bangalore KARNATAKA |
7019451164
jsoumya60@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee for Human Trials Approval Certificate |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Partially edentulous arch |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional impression using Laboratory Scanner |
Patients requiring implant crowns with adjacent implants will be subjected to conventional impression using Open tray impression technique and Scanned using Laboratory Scanner |
| Intervention |
TRIOS 3SHAPE intra oral Scanner |
Patients requiring implant crowns with two adjacent implants will be scanned with Trios 3shape intra oral scanner |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Both maxillary and mandibular arch
2. Dental arches with two or more adjacent missing teeth in anterior or posterior region.
3. Dental Implant with diameters ranging from 3.2 mm to 5 mm
|
|
| ExclusionCriteria |
| Details |
1. Patients with Chronic Systemic diseases affecting the bone healing or implant stability such as osteoporosis
2. Patients with uncontrolled diabetes, bleeding disorders, recent myocardial infarction and other immunocompromised conditions.
3. Chronic smokers, tobacco chewers
4. Lactating and pregnant women
5. Mini-implants of diameter lesser than 3mm
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the accuracy (inter-implant distance, linear deviation, angular deviation) of conventional and digital impressions |
Not applicable |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the patient satisfaction for both the groups |
|
|
|
Target Sample Size
|
Total Sample Size="21" Sample Size from India="21"
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)
|
30/12/2025 |
| 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)
|
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
|
Dental implants are the most preferred treatment options for restoring missing teeth, and accurate impressions are crucial for achieving a passively fitting prosthesis. The precision of the implant impression is affected by factors like materials, technique, splinting, level, depth, and implant angle. The goal is to accurately reproduce implant locations in three dimensions as well as in relation to the other intraoral hard and soft tissue structures. Conventional impression methods, which have been used for years, are associated with limitations such as dependence on operator skill and multiple clinical and laboratory steps (Heckmann et al., 2004). The advancement of digital technology in dental impressions, including the introduction of intraoral scanners, offers the potential for enhanced efficiency, greater patient comfort, and a minimized risk of human error. (Gjevold et al., 2016; Delize et al., 2019). In recent years, significant advancements have been made in dental implant impressions, aiming to enhance the accuracy of the prosthetic reconstruction process. Several literatures are available for in vitro studies regarding digital impressions in implants. However, there are very few in-vivo studies comparing digital and conventional impression techniques. Hence, the present study will be undertaken to evaluate the accuracy of conventional versus digital implant-level impression techniques in partially edentulous arches in a clinical scenario. Aim of the study: To evaluate and compare the accuracy of digital implant level impression technique with conventional implant level impression technique in partially edentulous clinical situations. Objectives of the study: 1.To obtain the STL file from conventional and digital implant level impression technique. 2.To compare the accuracy (inter implant distance, linear and angular deviation) of digital and conventional implant level impression techniques. |