Simplified Versus Conventional Complete Dentures

Not Applicable

Completed

• Conditions: Complete Edentulism
• Interventions: Procedure: Denture Fabrication technique

• Registration Number: NCT05069909
• Lead Sponsor: University of Jordan

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.

Study Timeline

• Study Start: 2019-09-10
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2021-09
• Study First Submitted: 2021-09-26
• Study First Submitted QC: 2021-09-26
• Last Update Submitted: 2021-09-26
• Study First Posted: 2021-10-06
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Conventional technique	Denture Fabrication technique	The group of patients who received dentures fabricated with conventional technique first
Simplified technique	Denture Fabrication technique	The group of patients who received dentures fabricated with simplified technique first

Primary Outcome Measures

Name	Time	Method
Patient satisfaction questionnaire	1 month after denture delivery	Visual analogue scale (0-10) for a 10 item questionnaire regarding patient satisfaction with the dentures
OHIP-EDENT	I month after denture delivery	20-item oral health impact profile for edentulous patients questionnaire

Trial Locations

Locations (1)

The University of Jordan; 🇯🇴 Amman, Jordan