The Impact of Palatal Rugae Addition to Complete Dentures on Patients' Satisfaction and Oral Health Related Quality of Life

ConditionEdentulism
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorPakistan Institute of Medical Sciences

About this trial

In conventional maxillary complete dentures, the palatal surface is typically smooth and polished, lacking the natural anatomy of the palatal rugae. While this design facilitates ease of cleaning, it may compromise the functional feedback required for speech and other oral functions. Since the palatal rugae contain mechanoreceptors essential for guiding the tongue during phonation and mastication, replicating these structures may enhance oral function and patient adaptation.

Given the variation in clinical outcomes reported in prior studies, a randomized crossover clinical trial is warranted to assess the impact of adding anatomically replicated palatal rugae to complete dentures.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients aged 45-80 years.

Completely edentulous for at least 3 months.

Seeking new complete maxillary dentures for the first time.

Provided written informed consent

Disqualifiers

Patients with severe systemic diseases or neuromuscular dysfunction.

Presence of mental or auditory impairment.

History of oral pathology, xerostomia, or ankyloglossia (tied tongue).

Previous or experienced complete denture wearers.

Trial design

Design model

Crossover

Treatments tested in this trial

  • complete dentures

    Device

    Participants were randomly allocated into two intervention sequences using a computer-generated randomization list. The two sequences were: * Group A: Received maxillary complete denture with palatal rugae first, followed by a smooth polished palatal surface denture after a 2-month adaptation period. * Group B: Received a smooth polished palatal surface denture first, followed by a rugae-enhanced denture after a 2-month adaptation period.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: with palatal rugae initiallyExperimental treatment 1 intervention
Group B: without palatal rugae initiallyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

General satisfaction

VAS score comparison between palatal contours

Time frame
2 months

Secondary outcomes

1

Satisfaction with eating, taste, speech, phonetics, ease of cleaning

OHIP

Time frame
2 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Pakistan Institute of Medical Sciences

Lead sponsor

Shaheed Zulfiqar Ali Bhutto Medical University

Sponsor institution

School of dentistry

Collaborator

Shaheed Zulfiqar Ali Bhutto Medical University Islamabad Pakistan

Collaborator