NCT05069909

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2019

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 26, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 6, 2021

Completed
Last Updated

October 6, 2021

Status Verified

September 1, 2021

Enrollment Period

1.7 years

First QC Date

September 26, 2021

Last Update Submit

September 26, 2021

Conditions

Complete Edentulism

Keywords

Simplified denturesimpression techniquescomplete edentulismborder moulding

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Conventional technique

ACTIVE COMPARATOR

The group of patients who received dentures fabricated with conventional technique first

Procedure: Denture Fabrication technique

Simplified technique

ACTIVE COMPARATOR

The group of patients who received dentures fabricated with simplified technique first

Procedure: Denture Fabrication technique

Interventions

Denture Fabrication techniquePROCEDURE

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

Conventional techniqueSimplified technique

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Jordan

Amman, 11942, Jordan

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
AssociateProfessor

Study Record Dates

First Submitted

September 26, 2021

First Posted

October 6, 2021

Study Start

September 10, 2019

Primary Completion

May 31, 2021

Study Completion

May 31, 2021

Last Updated

October 6, 2021

Record last verified: 2021-09

Locations

JO(1)