Simplified Versus Conventional Complete Dentures

Complete Edentulism Clinical Trial

Official title:

Simplified Versus Conventional Complete Dentures: A Randomized Crossover Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05069909
• Other study ID #: NEreifej
• Status: Completed
• Phase: N/A
• Start date: September 10, 2019
• Est. completion date: May 31, 2021

Study information

• Verified date: September 2021
• Source: University of Jordan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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: -

Related Conditions & MeSH terms

• Complete Edentulism

Intervention

Procedure:
• Denture Fabrication technique
Each patient received two sets of dentures fabricated using the two different techniques and their satisfaction and OHIP-EDENT were compared

Locations

Country	Name	City	State
Jordan	The University of Jordan	Amman

Sponsors (1)

Lead Sponsor	Collaborator
University of Jordan

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction questionnaire	Visual analogue scale (0-10) for a 10 item questionnaire regarding patient satisfaction with the dentures	1 month after denture delivery
Primary	OHIP-EDENT	20-item oral health impact profile for edentulous patients questionnaire	I month after denture delivery