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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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