Simplified Versus Conventional Complete Dentures

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-10

Study Completion Date

2021-05-31

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.

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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.

Conditions

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Complete Edentulism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Conventional technique

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

Group Type ACTIVE_COMPARATOR

Denture Fabrication technique

Intervention Type PROCEDURE

Each patient received two sets of dentures fabricated using the two different techniques and their satisfaction and OHIP-EDENT were compared

Simplified technique

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

Group Type ACTIVE_COMPARATOR

Denture Fabrication technique

Intervention Type PROCEDURE

Each patient received two sets of dentures fabricated using the two different techniques and their satisfaction and OHIP-EDENT were compared

Interventions

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Denture Fabrication technique

Each patient received two sets of dentures fabricated using the two different techniques and their satisfaction and OHIP-EDENT were compared

Intervention Type PROCEDURE

Eligibility Criteria

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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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