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Simplified Versus Conventional Complete Dentures

Simplified Versus Conventional Complete Dentures: A Randomized Crossover Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05069909
Enrollment
40
Registered
2021-10-06
Start date
2019-09-10
Completion date
2021-05-31
Last updated
2021-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complete Edentulism

Keywords

Simplified dentures, impression techniques, complete edentulism, border moulding

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.

Interventions

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

Sponsors

University of Jordan
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
40 Years to 85 Years
Healthy volunteers
Yes

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

\-

Design outcomes

Primary

MeasureTime frameDescription
Patient satisfaction questionnaire1 month after denture deliveryVisual analogue scale (0-10) for a 10 item questionnaire regarding patient satisfaction with the dentures
OHIP-EDENTI month after denture delivery20-item oral health impact profile for edentulous patients questionnaire

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026