Evaluation and comparison of functional and aesthetic outcomes of CAD-CAM Baltic denture and conventional complete denture.

Phase 1/2

Completed

• Conditions: Completely edentulous maxillary and mandibular arch; Complete loss of teeth,

• Registration Number: CTRI/2023/05/053220
• Lead Sponsor: Priyasha R. Wase

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-22
• Study Completion: 2024-02-20
• Last Update Posted: 2024-03-14

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 8

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Measures

Name	Time	Method
Difference in the functional, aesthetic outcomes, patient satisfaction and comfort between CAD-CAM Baltic denture system and bilaterally balanced complete denture prostheses.	1 month

Trial Locations

Locations (1)

Indira Gandhi Institute of Dental Sciences; 🇮🇳 Pondicherry, PONDICHERRY, India

Indira Gandhi Institute of Dental Sciences

🇮🇳Pondicherry, PONDICHERRY, India

Priyasha R Wase

Principal investigator

priyawase28@gmail.com