Simplified Versus Conventional Complete Dentures

University of Jordan

Status: Completed

Conditions: Complete Edentulism

Treatments: Procedure: Denture Fabrication technique

Study type: Interventional

Funder types: Other

Identifiers

NCT05069909

NEreifej

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 40 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

   Exclusion Criteria:

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Conventional technique

Active Comparator group

Description:

The group of patients who received dentures fabricated with conventional technique first

Treatment:

Procedure: Denture Fabrication technique

Simplified technique

Active Comparator group

Description:

The group of patients who received dentures fabricated with simplified technique first

Treatment:

Procedure: Denture Fabrication technique