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
|
|
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
|
|
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. |