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

ConditionEdentulism
Trial statusNot yet recruiting
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

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

Treatments tested in this trial

  • complete dentures

Treatment groups

60 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

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