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CTRI Number  CTRI/2020/03/024165 [Registered on: 23/03/2020] Trial Registered Prospectively
Last Modified On: 23/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Crossover Trial 
Public Title of Study   comparative study between digitally fabricated complete denture and conventional complete denture 
Scientific Title of Study   EVALUATION OF FUNCTIONAL AND ESTHETIC OUTCOMES OF CAD-CAM BALTIC DENTURE AND CONVENTIONAL DENTURE REMOVABLE PROSTHESES - A CROSS OVER 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  B T Pradeep Raja 
Designation  Postgraduate 
Affiliation  Indira Gandhi Institute of Dental Sciences 
Address  Department of Prosthodontics, Crown and Bridge, Indira Gandhi Institute of Dental Science, Sri Balaji Vidyapeeth, Pillayarkuppam. Pondicherry.

Pondicherry
PONDICHERRY
607402
India 
Phone  9976349663  
Fax    
Email  pradeeprajabt@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  P S Manoharan 
Designation  Head of the Department 
Affiliation  Indira Gandhi Institute of Dental Sciences 
Address  Department of Prosthodontics, Crown and Bridge Indira Gandhi Institute of Dental Science Sri Balaji Vidyapeeth Pillayarkuppam Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9865019673  
Fax    
Email  manoharanps@igids.ac.in  
 
Details of Contact Person
Public Query
 
Name  B T Pradeep Raja 
Designation  Postgraduate 
Affiliation  Indira Gandhi Institute of Dental Sciences 
Address  Department of Prosthodontics, Crown and Bridge Indira Gandhi Institute of Dental Science Sri Balaji Vidyapeeth Pillayarkuppam Pondicherry

Pondicherry
PONDICHERRY
607402
India 
Phone  9976349663  
Fax    
Email  pradeeprajabt@gmail.com  
 
Source of Monetary or Material Support  
DENTCARE DENTAL LAB PVT. LTD, MUVATTUPUZHA, KERALA 
 
Primary Sponsor  
Name  B T Pradeep Raja 
Address  DEPARTMENT OF PROSTHODONTICS, CROWN AND BRIDE, INDIRA GANDHI INSITUTE OF DENTAL SCIENCES, SRI BALAJI VIDHYAPEETH, PILLAYARKUPPAM PONDICHERRY- 607402 
Type of Sponsor  Other [Self] 
 
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 
B T Pradeep Raja  Indira Gandhi Institute of Dental Sciences  Department of Prosthodontics, Crown and Bridge
Pondicherry
PONDICHERRY 
9976349663

pradeeprajabt@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, INDIRA GANDHI INSTITUTE OF DENTAL SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures, (2) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  CAD-CAM COMPLETE DENTURE  DIGITALLY FABRICATED COMPLETE DENTURES WILL BE DELIVERED TO THE PATIENT AND OUTCOME MEASURES WILL BE ASSESSED 
Comparator Agent  CONVENTIONAL COMPLETE DENTURE  COMPLETE DENTURES FABRICATED WITH BALANCED OCCLUSION SCHEME WILL BE DELIVERED TO THE PATIENTS 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1.Completely edentulous patients with class I ridge relation, Class I &II ridge morphology (PDI).
2.Adult patients needing new complete dentures
3.Mentally receptiveness
4.Patients able to understand the informed consent
5.Patient who are able to come for 9-10 visits.
6.Absence of dysfunctional disorders of the masticatory system
7.Absence of debilitating systemic diseases
 
 
ExclusionCriteria 
Details  1.Refusal to participate in the study.
2.Patients with class II and class III ridge relation.
3.Patients with past history of Complete dentures
4.Symptoms of Temporomandibular disorders
5.Patients with severe xerostomia
6.Patients with parafunctional habits
7.Patients with severe oral manifestations of systemic disease
8.Psychologic or psychiatric conditions that could influence response to treatment.
9.Patient asking for implant supported/retained prostheses 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1.Functional outcomes - Blinded evaluation of retention and stability using functional assessment of denture - FAD questionnaire
2.Aesthetic outcomes - blinded evaluation of aesthetics using Frush and Fisher Aesthetics criteria
3.Patient satisfaction
4.Comfort- self evaluation of patients satisfaction and comfort by means of a denture satisfaction questionnaire
 
After one month of each intervention 
 
Secondary Outcome  
Outcome  TimePoints 
PATIENT QUALITY OF LIFE assessment of patients quality of life (OHRQoL) before and after treatment by means of Oral Health Impact Profile Questionnaire (OHIP19)  AFTER ONE MONTH OF EACH INTERVENTION 
 
Target Sample Size   Total Sample Size="8"
Sample Size from India="8" 
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)   02/04/2020 
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   NOT YET PUBLISHED 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Conventional method of fabricating Complete Dentures [CD] has been in practice since 1860’s . Bilateral Balanced articulation have been proposed as one of the functionally advantageous Denture System in terms of stability, even distribution of forces and denture comfort . Conventional Complete Dentures and Dentures constructed with Bilateral balanced Articulation has the additional advantage of predictable aesthetics, as individualised teeth arrangement is possible including characterisation of pink and white aesthetics. Through the years, the continuing goal was to overcome all the drawbacks associated with the process of fabrication, and enhancements of the properties of materials used for denture base and teeth. No significant changes were noted in the impression making and jaw relation procedures involved with conventional complete denture fabrication. The introduction and evolution of computer-aided technology in the field of CD fabrication has considerably reduced the time spent in fabrication and they claim with the availability of the necessary armamentarium dentures can be fabricated in a single day . The first scientific paper on the use of a computer-aided system for designing and fabricating CDs was published by Maeda et al., in 1994, and these dentures were made by additive Rapid Prototyping [RP] technology, from photo-polymerised acrylate material using a 3-dimensional Laser Lithographic (LL) machine. It took almost 20 years for the emergence of the first commercially available denture systems. Very few studies and reports are available on the outcome evaluation of the newly introduced Baltic system . The advantage of time and simplicity of the procedure have attracted the clinicians and have urged them to cater to the demanding patients overlooking the cost which is involved in the process.With the mentioned advantages and disadvantages of the two systems, it is planned to conduct a clinical trial to study the functional and aesthetic outcomes of the patient with conventional complete denture system with bilateral balanced articulation and Baltic denture system.

 
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