| CTRI Number |
CTRI/2024/09/074333 [Registered on: 25/09/2024] Trial Registered Prospectively |
| Last Modified On: |
09/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
evaluation of the accuracy of implant crown fabricated by two different methods |
|
Scientific Title of Study
|
Comparative evaluation of marginal and internal fit of single posterior implant retained crown fabricated using conventional and digital impression workflow- an in vivo 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 |
Prerna Suresh Kalyani |
| Designation |
Postgraduate student |
| Affiliation |
KLE VK INSTITUTE OF DENTAL SCIENCE |
| Address |
Department number 3, Department of prosthodontics crown and bridge ground floor, KAHER KLE Vishwanath Katti Institute of
Dental Sciences, JNMC Campus,Nehru Nagar Belgaum
KARNATAKA 590010
Belgaum
K.L.E.V.K.INSTITUE OF DENTAL SCIENCE, Belgaum KARNATAKA 590010 India |
| Phone |
07020049533 |
| Fax |
|
| Email |
prernakalyani95@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Anankumar.G Patil |
| Designation |
Professor |
| Affiliation |
KLE VK INSTITUTE OF DENTAL SCIENCE |
| Address |
Department number 3, Department of prosthodontics crown and bridge ground floor, KAHER KLE Vishwanath Katti Institute of
Dental Sciences, JNMC Campus,Nehru Nagar Belgaum
KARNATAKA 590010
Belgaum
K.L.E.V.K.INSTITUE OF DENTAL SCIENCE, Belgaum KARNATAKA 590010 India |
| Phone |
8792650805 |
| Fax |
|
| Email |
patilprostho@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Prerna Suresh Kalyani |
| Designation |
Postgraduate student |
| Affiliation |
KLE VK INSTITUTE OF DENTAL SCIENCE |
| Address |
Department number 3, Department of prosthodontics crown and bridge ground floor, KAHER KLE Vishwanath Katti Institute of
Dental Sciences, JNMC Campus,Nehru Nagar Belgaum
KARNATAKA 590010
Belgaum
K.L.E.V.K.INSTITUE OF DENTAL SCIENCE, Belgaum KARNATAKA 590010 India |
| Phone |
07020049533 |
| Fax |
|
| Email |
prernakalyani95@gmail.com |
|
|
Source of Monetary or Material Support
|
| KAHER’s KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus, Nehru Nagar,
Belagavi, 590010, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
prerna kalyani |
| Address |
Department number 3,
Department of
prosthodontic crown and bridge
ground floor.
Belgaum
KARNATAKA |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| prerna kalyani |
Department number 3,
Department of
prosthodontic crown and bridge
ground floor.
Belgaum
KARNATAKA |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| PRERNA KALYANI |
KAHER KLE Vishwanath Katti Institute of Dental Sciences, JNMC Campus,Nehru Nagar |
Department number 3,
Department of
prosthodontoc crown and bridge,
second floor.
Belgaum
KARNATAKA Belgaum KARNATAKA |
7020049533
prernakalyani95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee KLE VKIDS |
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 |
| Comparator Agent |
conventional workflow |
accuracy of implant crown |
| Intervention |
digital workflow |
accuracy of implant crown |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patient age between 21-60 years.
2 Patient in need of an implant supported crown in the molar region who have successfully completed stage 1 of implant treatment.
3 Absence of any medical condition.
4 Absence of any periodontal disease.
5 Opposing dentition should be natural teeth or fixed definitive restoration on teeth or implant.
6 Presence of at least one intact adjacent tooth or fixed definitive restoration on teeth or implant.
7 Patients who are willing to participate in the present study and willing sign the informed consent form.
|
|
| ExclusionCriteria |
| Details |
1 Participants with inadequate oral hygiene.
2 Implants showing signs of peri-implantitis.
3 Presence of periapical radiolucency at adjacent teeth.
4 Periodontitis or persistent intraoral infections.
5 Absence of adjacent teeth.
6 Untreated mucosal diseases.
7 Presence of parafunctional habits
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| • To evaluate marginal and internal fit of single posterior implant retained crown fabricated using conventional and digital impression workflow |
• baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| • To compare marginal & internal fit of single posterior implant retained crown fabricated using conventional & digital impression workflow. |
baseline |
|
|
Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
30/09/2024 |
| 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="0" Months="5" 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
|
Implant-supported fixed dental prostheses have become a well-accepted treatment option with acceptable success rates for partially edentulous patients. This success can only be achieved with a precise fit of the implant supported restoration, which is critical to the long-term success of any dental restoration. The gap between the implant abutment and the restoration allows bacteria to adhere, causing inflammatory reaction in the peri implant soft tissues and biologic complications of the surrounding tissues. Conventional fixture-level implant impression techniques in combination with master casts and porcelain fused to metal (PFM) crowns still represent the gold standard in the manufacturing process of fixed implant-supported restorations. However, it is often associated with long time-consuming appointment, complex technique sensitive fabrication steps using expensive equipment, materials, as well as patient related hindrances like suffocation hazard, gagging and taste irritation during the impression taking procedures. An alternative to the well-established conventional impression technique is the next gen digital approach. The clinical patient situation is virtually registered with a contact-free transfer using an intraoral optical scanner (IOS) system. With regard to accuracy, clinical and in vitro studies have reported variability in results when comparing digital scanning with conventional impression procedures for tooth supported fixed partial dentures. Additionally, the accuracy of digital scanning has been reported to depend on the scanning protocol, operator experience and training, type of arch scans, and use of a reflective agent. Although many in vitro studies have been conducted to evaluate marginal and internal fit of implant supported restorations, very few in vivo studies have been carried out to evaluate the same. So, the objective of this in vivo study is to evaluate and compare marginal and internal fit of implant retained prostheses fabricated using conventional and digital workflow. |