The Impact of Rugae Reproduction on Complete Dentures Patients' Satisfaction

NCT03879083 | Completed

• 1 other identifier: 10/2019/27400
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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. 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 reproduction of their rugae on the anterior palatal area as opposed to a polished palatal surface.

Conditions

Edentulous Jaw

Outcome Measures

Primary Outcomes (1)

• 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').

  60 days

Secondary Outcomes (6)

• Patients reported oral health related quality of life

  60 days

• Patients' reported overall satisfaction with their dentures during speaking.

  60 days

• Patients' reported overall satisfaction with their dentures during eating

  60 days

• Patients' reported overall satisfaction with their dentures during drinking

  60 days

• Patients' reported overall satisfaction with their ability to clean their dentures

  60 days

Study Arms (2)

With reproduction of palatal rugae

EXPERIMENTAL

Participants will receive maxillary complete dentures with a reproduction of the patients's own palatal rugae to the palatal surface.

Other: The removal of the palatal rugae from the complete denture surface

Without reproduction of palatal rugae (smooth surface)

ACTIVE COMPARATOR

Participants will receive maxillary complete dentures with smooth palatal surfaces without a reproduction of the patients's own palatal rugae to the palatal surface.

Other: Addition of palatal rugae to the complete denture surface

Interventions

Addition of palatal rugae to the complete denture surface OTHER

The addition and reproduction of the patient's own palatal rugae to the complete maxillary denture palatal surface.

Without reproduction of palatal rugae (smooth surface)

The removal of the palatal rugae from the complete denture surface OTHER

The removal of the palatal rugae from the complete maxillary denture palatal surface to become a smooth surface

With reproduction of palatal rugae

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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.

Sponsors & Collaborators

• University of Jordan: lead

Study Sites (1)

University of Jordan Hospital

Amman, 11942, Jordan

Location

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth 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
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Patients will randomly be allocated to either group A/B or B/A. Group A: Patients receiving a reproduction of their palatal rugae Group B: Patients receiving a smooth palatal surface. 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 periodthe same process will be repeated.

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 18, 2019
• Study Start: May 1, 2019
• Primary Completion: December 25, 2019
• Study Completion: February 25, 2020
• Last Updated: April 28, 2020

Record last verified: 2020-04

Locations

JO (1)