| CTRI Number |
CTRI/2024/12/078620 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
21/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Clinical assessment of the minimally prepared bridge made of zirconia for premolar and molar - A clinical study |
|
Scientific Title of Study
|
Evaluation of the clinical outcome of posterior Inlay retained Zirconia fixed dental prosthesis - An invivo 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 |
SUSHMITHA MOHAN |
| Designation |
Post-graduate student |
| Affiliation |
Government Dental College and Hospital, Cuddalore District |
| Address |
Department of Prosthodontics and Crown & Bridge, Government Dental College and Hospital, Annamalai Nagar, Chidambaram – 608002, Cuddalore District.
Cuddalore TAMIL NADU 608002 India |
| Phone |
7397600177 |
| Fax |
|
| Email |
sushmithamohan2112@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr S SEYED ASHARAF ALI |
| Designation |
Professor |
| Affiliation |
Government Dental College and Hospital, Cuddalore District |
| Address |
Department of Prosthodontics and Crown & Bridge, Government Dental College and Hospital, Annamalai Nagar, Chidambaram – 608002, Cuddalore District.
Cuddalore TAMIL NADU 608002 India |
| Phone |
8012233001 |
| Fax |
|
| Email |
jsldental@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr S SEYED ASHARAF ALI |
| Designation |
Professor |
| Affiliation |
Government Dental College and Hospital, Cuddalore District |
| Address |
Department of Prosthodontics and Crown & Bridge, Government Dental College and Hospital, Annamalai Nagar, Chidambaram – 608002, Cuddalore District.
Cuddalore TAMIL NADU 608002 India |
| Phone |
8012233001 |
| Fax |
|
| Email |
jsldental@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental College and Hospital, Cuddalore Erstwhile Rajah Muthiah Dental college and hospital, Chidambaram, Cuddalore,Tamilnadu -608002 |
|
|
Primary Sponsor
|
| Name |
Sushmitha Mohan |
| Address |
Department of Prosthodontics and Crown & Bridge, Government Dental College and Hospital, Annamalai Nagar, Chidambaram – 608002, Cuddalore District. |
| Type of Sponsor |
Other [Self funding] |
|
|
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 Sushmitha Mohan |
Government Dental College - Cuddalore |
Department of Prosthodontics and Crown and Bridge, Government Dental College - Cuddalore
Annamalai Nagar, Chidambaram -608002 Cuddalore TAMIL NADU |
7397600177
sushmithamohan2112@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Medical College and Hospital,Cuddalore district, Annamalai nagar 608002,INSTITU TIONAL HUMAN ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inlay retained fixed dental prosthesis |
Inlays are utilized to support fixed prosthetic restorations instead of the conventional full coverage retainers. Also the prosthesis is made of Zirconia to withstand the flexural load (T 1-4 months) |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Single missing posterior teeth
Vital and Periodontally stable abutments
Pulpal roof 5mm away from outer tooth surface
|
|
| ExclusionCriteria |
| Details |
Abutments with surface tooth wear
Abutment with extensive caries and restoration
Patients with parafunctional habits
Known allergies to the materials used in the study
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
According to revised FDI criteria (2020), the following parameters are assessed;
FUNCTIONAL PROPERTIES, BIOLOGICAL PROPERTIES & AESTHETIC PROPERTIES |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| FUNCTIONAL PROPERTIES: To assess the fracture of material & retention, marginal adaptation, form & contour & occlusion & wear. |
12 months |
| BIOLOGICAL PROPERTIES: To assess the caries at restoration margin, dental hard tissue defects at restoration margin, postoperative (hyper) sensitivity/ pulpal status. |
12 months |
| AESTHETIC PROPERTIES: To assess the surface luster & surface texture, marginal staining & colour match. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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 4 |
|
Date of First Enrollment (India)
|
15/01/2025 |
| 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="1" Months="1" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Fixed dental prostheses (FDP) with full coverage retainers, have been the standard for replacement of a single missing tooth. Conventional full-crown preparation designs for FDPs have been reported to require a removal of up to 67.5% to 75.6% of coronal tooth structure, which in many cases is sound and unaffected. Such extensive preparations have resulted in post procedural sensitivity/ pain of the abutment teeth, open margins especially in the interproximal regions, improper proximal contacts resulting in food impaction and improper occlusal morphology and contacts resulting in compromised chewing efficiency. This all indicates the need for a more conservative approach in replacing missing dentition. Since minimally invasive dentistry has been considered to be a rational approach in the current diagnostic and treatment planning regimen, the desire for inlay-retained fixed partial dentures (IRFPD) to preserve tooth structure and restrict abutment preparation has increased. Various materials like Resin-based composite block materials, High-strength heat-pressed lithium-disilicate ceramics, Yttria partially stabilized zirconium-oxide ceramic (YPSZ) have been used as a core material for fabrication of IRFPD. YPSZ has high flexural strength of 900-1000 MPa making it a suitable esthetic posterior FDP material. Other than few case reports, there is a scientific lacuna in studies reporting the clinical performance of inlay retained FDP. This study attempts to evaluate the 12 months clinical performance of Zirconia, inlay retained, fixed dental prosthesis. |