Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07034079

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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. This study aims to evaluate whether incorporating palatal rugae can improve patient satisfaction and oral health-related quality of life when compared to conventional dentures with a smooth palatal surface.

By assessing patient-reported outcomes in a controlled and systematic manner, this research will contribute valuable evidence toward optimizing complete denture design for better functional and psychological outcomes in edentulous patients.

OBJECTIVE

  • To compare conventional complete maxillary dentures with a smooth, polished palatal surface to those incorporating anatomical palatal rugae, in terms of patient-reported outcomes and oral health-related quality of life.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • Motivated and compliant patients, willing to return for follow-up (helps reduce attrition bias)
  • Patients with Class I maxillomandibular relationship

Exclusion criteria

  • 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.
  • Patient with strong gag reflex

Treatment and study plan

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.

Primary outcomes

  1. General satisfaction

    Time frame: 2 months

    VAS score comparison between palatal contours

Secondary outcomes

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

    Time frame: 2 months

    OHIP

Sponsors and collaborators

Lead sponsor

Pakistan Institute of Medical Sciences

Other Gov

Collaborators

  • School of dentistry
  • Shaheed Zulfiqar Ali Bhutto Medical University Islamabad Pakistan

Registry information

Official study title

The Impact of Palatal Rugae Addition to Complete Dentures on Patients' Satisfaction and Oral Health Related Quality of Life: A Randomized Crossover Clinical Trial

Acronym: Palatal rugae

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2025
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.