| CTRI Number |
CTRI/2014/07/004779 [Registered on: 25/07/2014] Trial Registered Retrospectively |
| Last Modified On: |
18/07/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Clinical Evaluation of computer designed and fabricated temporary teeth. |
|
Scientific Title of Study
|
Clinical Evaluation of CAD CAM fabricated Longterm provisional fixed partial dentures - A Randomised clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
R Murali Karthik |
| Designation |
Postgraduate Student |
| Affiliation |
Saveetha university |
| Address |
Dept of Prosthodontics
saveetha dental college
Thiruverkadu
Chennai
TAMIL NADU
600077
India |
| Phone |
9600141012 |
| Fax |
|
| Email |
murali2002karthik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Padma Ariga |
| Designation |
Professor |
| Affiliation |
Saveetha dental college |
| Address |
Head Of the Dept
Department of Prosthodontics
Saveetha dental college
velappanchavadi
Chennai
TAMIL NADU
600077
India |
| Phone |
9840062990 |
| Fax |
|
| Email |
padma-ariga@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
R Murali Karthik |
| Designation |
Postgraduate Student |
| Affiliation |
Saveetha university |
| Address |
Dept of Prosthodontics
saveetha dental college
Thiruverkadu
Chennai
TAMIL NADU
600004
India |
| Phone |
9600141012 |
| Fax |
|
| Email |
murali2002karthik@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Saveetha university |
| Address |
Thiruverkadu, chennai 77 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Murali karthik |
Saveetha dental college, Dept of Prosthodontics, clinic No:24 |
velappanchavadi, chennai-77
Chennai
TAMIL NADU |
9600141012
murali2002karthik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional human ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
-Subjects with bilaterally missing teeth
-Subjects with abutmrnt teeth having a bone loss of 2-6mm with a history of periodontal treatment and willing for long term provisional fixed partial dentures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CAD CAM fabricated longterm methacrylate provisional fixed partial denture |
Temporary fixed partial denture for the prepared abutment tooth before the definitive prosthesis. |
| Comparator Agent |
Heat processed longterm methacrylate provisional fixed partial denture |
Temporary fixed partial denture for the prepared abutment tooth before the definitive prosthesis. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
-Subjects with missing teeth on either side of the mouth
-subjects with abutment teeth having a bone loss 2-6mm with history of periodontal treatment
-Good oral hygiene.
|
|
| ExclusionCriteria |
| Details |
-subjects with poor oral hygiene compliance
-Subjects with known allergic to acrylic materials
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| clinical survival (clinical observation of fracture, cracks and decementation of fixed partial dentures), marginal adaptation , anatomical form and gingival health by modified Ryge criteria |
Baseline(24 hours), 1 month and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| secondary caries, anatomic form, surface roughness of the provisional fixed partial dentures by modified Ryge criteria |
Baseline(24 hrs), 1 month and 3 month |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/07/2013 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Provisional restorations should provide pulp and periodontal protection, have good marginal integrity, esthetics and have sufficient durability to withstand the forces of mastication. Fracture of provisional restoration is of concern, especially with long span fixed partial dentures, long term interim fixed partial denture indicated for periodontally involved abutments, Bruxers, temporization of implants during healing period, complex rehabilitations. In contrast to conventional temporary materials, the industrially produced blocks offer the advantage of high fracture resistance(Vanessa et al,2011). In addition these blocks also eliminate the problem of polymerization shrinkage which affects the fit of the restoration, good surface texture and esthetics.. Hence the purpose of the study is to compare the clinical survival , marginal fit, colour stability, and periodontal outcome of the CADCAM fabricated provisional fixed partial dentures to conventional methacrylate fixed partial dentures |