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Completed

NCT Number: NCT05069909

Simplified Versus Conventional Complete Dentures

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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Key information

Conditions

Complete Edentulism

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Jordan

Amman, 11942, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Exclusion criteria

-

Treatment and study plan

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

Primary outcomes

  1. Patient satisfaction questionnaire

    Time frame: 1 month after denture delivery

    Visual analogue scale (0-10) for a 10 item questionnaire regarding patient satisfaction with the dentures

  2. OHIP-EDENT

    Time frame: I month after denture delivery

    20-item oral health impact profile for edentulous patients questionnaire

Sponsors and collaborators

Lead sponsor

University of Jordan

Other

Registry information

Official study title

Simplified Versus Conventional Complete Dentures: A Randomized Crossover Clinical Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 6, 2021
Registry last updated
Oct 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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