Clinical trial NCT05069909: Simplified Versus Conventional Complete Dentures
Official title: Simplified Versus Conventional Complete Dentures: A Randomized Crossover Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Complete Edentulism
Keywords: Simplified dentures
impression techniques
complete edentulism
border moulding
Lead sponsor: University of Jordan
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria: Inclusion Criteria

1. Patients seeking new conventional complete dentures for first time or as replacement of their previous complete dentures
2. Patients aged 40-85 y.
3. Patients who had been completely edentulous for at least 6 months
4. Patients who had well developed to moderately resorbed maxillary and mandibular ridges
5. Patients who had no denture fissuratum or any traumas from previous dentures
6. 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.
7. Patients had medical and dental insurance to cover the fees for construction of dentures by a Prosthodontic specialist
8. Patients who signed consent form

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   Exclusion Criteria:

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Primary outcomes:
measure: Patient satisfaction questionnaire
timeFrame: 1 month after denture delivery
measure: OHIP-EDENT
timeFrame: I month after denture delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: The University of Jordan
Study officials:
References: