Simplified Versus Conventional Complete Dentures

Simplified Versus Conventional Complete Dentures: A Randomized Crossover Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Complete Edentulism
• Intervention / Treatment: Procedure: Denture Fabrication technique

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Amman, Jordan, 11942
    • The University of Jordan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional technique; The group of patients who received dentures fabricated with conventional technique first	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
Active Comparator: Simplified technique; The group of patients who received dentures fabricated with simplified technique first	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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Jordan

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2019
• Primary Completion (Actual): May 31, 2021
• Study Completion (Actual): May 31, 2021

Study Registration Dates

• First Submitted: September 26, 2021
• First Submitted That Met QC Criteria: September 26, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): October 6, 2021
• Last Update Submitted That Met QC Criteria: September 26, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Simplified dentures; impression techniques; complete edentulism; border moulding
• Other Study ID Numbers: NEreifej

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Study Protocol, Data analyses and results of both questionnaires will be shared

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No