Evaluation of Functional and Esthetic outcomes of Removable Complete Dentures fabricated with CAD/CAM technology- A Cross-over Randomized Controlled Clinical Trial
Trial Snapshot
- Phase
- Phase 1/2
- Status
- Completed
- Sponsor
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Difference in the functional, aesthetic outcomes, patient satisfaction and comfort between CAD-CAM Baltic denture system and bilaterally balanced complete denture prostheses.
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant and Investigator Blinded
Eligibility Criteria
- Ages
- 45.00 Year(s) to 75.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Difference in the functional, aesthetic outcomes, patient satisfaction and comfort between CAD-CAM Baltic denture system and bilaterally balanced complete denture prostheses.
Time Frame: 2 months
Secondary Outcomes
- Difference in the functional, aesthetic outcomes, patient satisfaction and comfort between CAD-CAM Baltic denture system and bilaterally balanced complete denture prostheses.(1 month)