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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional technique | Active Comparator | The group of patients who received dentures fabricated with conventional technique first |
|
| Simplified technique | Active Comparator | The group of patients who received dentures fabricated with simplified technique first |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Denture Fabrication technique | Procedure | Each patient received two sets of dentures fabricated using the two different techniques and their satisfaction and OHIP-EDENT were compared |
| 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 |
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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
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Jordan | Amman | 11942 | Jordan |
Study Protocol, Data analyses and results of both questionnaires will be shared
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