| CTRI Number |
CTRI/2023/05/053220 [Registered on: 29/05/2023] Trial Registered Prospectively |
| Last Modified On: |
14/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Evaluation and comparison of functional and aesthetic outcomes of CAD-CAM Baltic denture and conventional complete denture. |
|
Scientific Title of Study
|
Evaluation of Functional and Esthetic outcomes of Removable Complete Dentures fabricated with CAD/CAM technology- A Cross-over Randomized Controlled 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 |
PRIYASHA RAVINDRANATH WASE |
| Designation |
Post-graduate Student |
| Affiliation |
Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth, Pondicherry |
| Address |
INDIRA GANDHI INSTITUTE OF DENTAL SCIENCES, SRI BALAJI VIDYAPEETH, PONDICHERRY
DEPARTMENT OF PROSTHODONTICS, INDIRA GANDHI INSTITUTE OF DENTAL SCIENCES, SRI BALAJI VIDYAPEETH, PONDICHERRY
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9923528472 |
| Fax |
|
| Email |
priyawase28@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MANOHARAN P S |
| Designation |
Professor and Head of the Department |
| Affiliation |
Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth, Pondicherry |
| Address |
INDIRA GANDHI INSTITUTE OF DENTAL SCIENCES, SRI BALAJI VIDYAPEETH, PONDICHERRY
INDIRA GANDHI INSTITUTE OF DENTAL SCIENCES, SRI BALAJI VIDYAPEETH, PONDICHERRY
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9865019673 |
| Fax |
|
| Email |
manoharanps@igids.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
PRIYASHA RAVINDRANATH WASE |
| Designation |
Post-graduate Student |
| Affiliation |
Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth, Pondicherry |
| Address |
INDIRA GANDHI INSTITUTE OF DENTAL SCIENCES, SRI BALAJI VIDYAPEETH, PONDICHERRY
INDIRA GANDHI INSTITUTE OF DENTAL SCIENCES, SRI BALAJI VIDYAPEETH, PONDICHERRY
Pondicherry
PONDICHERRY
607402
India |
| Phone |
9923528472 |
| Fax |
|
| Email |
priyawase28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth, Pondicherry |
|
|
Primary Sponsor
|
| Name |
Priyasha R. Wase |
| Address |
406 Shree Nagar empress mills colony near narendra nagar ring road, Nagpur, Maharashtra |
| Type of Sponsor |
Other [Self sponsored] |
|
|
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 |
| Priyasha R Wase |
Indira Gandhi Institute of Dental Sciences |
Department of Prosthodontics and Crown & Bridge, Indira Gandhi Institute of Dental Sciences, Sri Balaji Vidyapeeth
Pondicherry
PONDICHERRY |
992328472
priyawase28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Internal Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Completely edentulous maxillary and mandibular arch |
| Patients |
(1) ICD-10 Condition: K081||Complete loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CAD/CAM Complete Denture |
1 Set of complete denture given for 1 month and then follow up |
| Comparator Agent |
Conventional complete dentures |
1 set of complete denture to be given for 1 month |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Completely edentulous patients with class I ridge relation, Class I and II ridge morphology (PDI)
Adult patients needing new complete dentures
Mentally receptiveness
Patients able to understand the informed consent
Patient who are able to come for 9-10 visits.
Absence of dysfunctional disorders of the masticatory system
Absence of debilitating systemic diseases |
|
| ExclusionCriteria |
| Details |
Refusal to participate in the study.
Patients with class II and class III ridge relation.
Patients with past history of Complete dentures
Symptoms of Temporomandibular disorders
Patients with severe xerostomia
Patients with parafunctional habits
Patients with severe oral manifestations of systemic disease
Psychologic or psychiatric conditions that could influence
response to treatment.
Patient asking for implant supported/retained prostheses
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in the functional, aesthetic outcomes, patient satisfaction and comfort between CAD-CAM Baltic denture system and bilaterally balanced complete denture prostheses. |
2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Difference in the functional, aesthetic outcomes, patient satisfaction and comfort between CAD-CAM Baltic denture system and bilaterally balanced complete denture prostheses. |
1 month |
|
|
Target Sample Size
|
Total Sample Size="8"
Sample Size from India="8"
Final Enrollment numbers achieved (Total)= "8"
Final Enrollment numbers achieved (India)="8" |
|
Phase of Trial
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
22/06/2023 |
| Date of Study Completion (India) |
20/02/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="7"
Days="10" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
EVALUATION OF FUNCTIONAL AND ESTHETIC OUTCOMES OF REMOVABLE COMPLETE DENTURES FABRICATED WITH CAD-CAM TECHNOLOGY A CROSS OVER RANDOMISED CONTROLLED CLINICAL TRIAL 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 objectives of this study is to compare between CAD-CAM Baltic denture system and bilateral balanced complete denture prostheses, by Blinded evaluation of retention and stability using functional assessment of denture- FAD Questionnaire. Blinded evaluation of aesthetics using Frush and Fisher Aesthetics criteria. Self -Evaluation of Patient’s satisfaction and comfort by means of a Denture Satisfaction Questionnaire. Assessment of Patients quality of life (OHRQoL) before and after treatment by means of Oral Health Impact Profile Questionnaire (OHIP’19). 8 completely edentulous patients with Class I ridge relationship will be selected through convenient sampling. 2 sets of complete dentures – One CAD-CAM Baltic denture system and One conventionally fabricated complete denture will be fabricated for each patient. Once the dentures are fabricated randomization will be done for the type of denture which the patient will be given first. Patients will be BLINDED for the type of denture which is given to them |