Simplified Versus Conventional Complete Dentures

Study Overview
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Brief Summary
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The purpose of this randomized, double-blind, 2-period crossover trial was to assess the satisfaction of edentulous patients and their oral health impact profile when provided with complete dentures fabricated using the conventional and simplified techniques.

Detailed Description
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40 completely edentulous patients, aged 40-85 years, with no relevant medical conditions, seeking complete dentures at a university hospital were included in this study. Those were randomly divided into two groups (n=20). Each group received two sets of dentures, the Group (S) were given the dentures constructed using the simplified technique first while the Group (C) received the dentures constructed using the conventional technique. After 1 month of the first set of dentures delivery, participants were asked to rate their general satisfaction on a 10-cm visual analogue scale in addition to their satisfaction regarding comfort, retention, stability, efficiency of mastication and speaking. Participants were also asked to fill the 20-item oral health impact profile for edentulous patients (OHIP-EDENT). Thereafter, each group of patients were given the set of dentures constructed using the other technique, given instructions and recalled after 1 month to evaluate the alternate set of dentures. 2 Prosthodontists performed all the clinical procedures and 1 laboratory technician performed the laboratory procedures. The results of the study were analyzed using Wilcoxon-signed rank test at significance level of 0.05.

Official Title
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Simplified Versus Conventional Complete Dentures: A Randomized Crossover Clinical Trial

Conditions
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Complete Edentulism

Intervention / Treatment
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* Procedure: Denture Fabrication technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria Patients seeking new conventional complete dentures for first time or as replacement of their previous complete dentures Patients aged 40-85 y. Patients who had been completely edentulous for at least 6 months Patients who had well developed to moderately resorbed maxillary and mandibular ridges Patients who had no denture fissuratum or any traumas from previous dentures Patients who had no relevant medical issues, disorders of the masticatory system, neuromuscular dysfunction, auditory problems, psychological or psychiatric conditions that can affect the response to treatment, oral pathology, xerostomia, or tied tongue condition. Patients had medical and dental insurance to cover the fees for construction of dentures by a Prosthodontic specialist Patients who signed consent form - Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional technique<br>The group of patients who received dentures fabricated with conventional technique first | Procedure: Denture Fabrication technique<br>* Each patient received two sets of dentures fabricated using the two different techniques and their satisfaction and OHIP-EDENT were compared<br>|
| Active Comparator: Simplified technique<br>The group of patients who received dentures fabricated with simplified technique first | Procedure: Denture Fabrication technique<br>* Each patient received two sets of dentures fabricated using the two different techniques and their satisfaction and OHIP-EDENT were compared<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction questionnaire | Visual analogue scale (0-10) for a 10 item questionnaire regarding patient satisfaction with the dentures | 1 month after denture delivery | 
| OHIP-EDENT | 20-item oral health impact profile for edentulous patients questionnaire | I month after denture delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Simplified dentures, impression techniques, complete edentulism, border moulding