NCT04985747

Brief Summary

The palatal rugae, refer to asymmetrical and irregular elevations of the mucosa located in the anterior third of the palate, on each side of the median palatal raphe and behind the incisive papilla. The lack of the rugae area on the polished areas of the dentures has been suggested to impact phonetics in denture patients due to lack of tactile feedback. Therefore, the aim of this randomized crossover clinical trial was to compare patients' reported satisfaction with their complete dentures and oral health related quality of life, when provided with a denture with a rough palatal surface in the rugae area compared with a polished palatal surface or an open palatal surface.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2021

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 21, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 2, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

July 5, 2023

Status Verified

July 1, 2023

Enrollment Period

1.7 years

First QC Date

July 21, 2021

Last Update Submit

July 1, 2023

Conditions

Edentulous Jaw

Outcome Measures

Primary Outcomes (1)

  • 100mm Visual analogue scale of patients' reported overall satisfaction with their dentures

    Patients overall satisfaction rate using visual analogue scale (a measurement instrument represented in a straight horizontal line of fixed length, 100 mm. The ends are defined as the extreme limits of the parameter to be measured (satisfied and unsatisfied). Orientated from the left 'best' to the right 'worst').

    90 days

Secondary Outcomes (4)

  • OHIP-EDENT Measure

    90 days

  • 100mm Visual analogue scale of patients' reported overall satisfaction with their dentures during speaking

    90 days

  • 100mm Visual analogue scale of patients' reported overall satisfaction with their ability to clean their dentures

    90 days

  • 100mm Visual analogue scale of patients' reported overall satisfaction with their phonetics

    90 days

Study Arms (3)

Polished palate

EXPERIMENTAL

Participants will receive maxillary complete dentures with smooth palatal surfaces without modification.

Other: Roughened palatal surfaceOther: Opened palatal surface

Roughened palate

EXPERIMENTAL

Participants will receive maxillary complete dentures with roughened palatal surfaces

Other: Polished palatal surfaceOther: Opened palatal surface

Open palate

EXPERIMENTAL

Participants will receive maxillary complete dentures with opened palatal surfaces

Other: Polished palatal surfaceOther: Roughened palatal surface

Interventions

Polished palatal surfaceOTHER

Polishing of the anterior palatal surface using a polisher

Open palateRoughened palate
Roughened palatal surfaceOTHER

Roughening of the anterior palatal surface using a sandblaster

Open palatePolished palate
Opened palatal surfaceOTHER

Opening of the anterior palatal surface using acrylic bur

Polished palateRoughened palate

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients seeking a set of conventional maxillary and mandibular complete dentures at the University of Jordan Hospital, for the first time or as a replacement of their previous dentures.
  • Patients aged between 45 and 80 years old.
  • Patients had been completely edentulous for at least 3 months
  • Patients without severe underlying medical conditions, neuromascular dysfunction, auditory problems, mental conditions, oral pathology, xerostomia, or tied tongue condition.
  • Patients who approved and consented to participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Jordan Hospital

Amman, 11942, Jordan

Location

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor will not be aware of which group he/she is interviewing at the assessment session.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Patients will randomly be allocated to either group P/R/O. Group P: Patients receiving a smooth palatal surface. Group R: Patients receiving a rough surface in the rugae area. Group O: Patients receiving an open surface in the rugae area After insertion, all participants will be followed up for a minimum of 1 week to correct any issues with the dentures and eliminate patient complaints. All patients will be recalled at 2 month after insertion to answer questions using the VAS and to fill out the Oral Health Impact Profile-20 EDENT (OHIP-EDENT), and receive the other type of palatal contour. After the second and third period the same process will be repeated.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 21, 2021

First Posted

August 2, 2021

Study Start

April 15, 2021

Primary Completion

January 1, 2023

Study Completion

January 1, 2023

Last Updated

July 5, 2023

Record last verified: 2023-07

Locations

JO(1)