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

Recruiting now · Phase 2

Conditions studied: Edentulism

In brief

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.

Key facts

Study ID

NCT07034079

Run by

Pakistan Institute of Medical Sciences

People needed

60

Starts

2026-07-01

Expected to finish

2026-12-31

Last updated by the study team

2026-07-07

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• School of Dentistry, SZABMU — Islamabad, Islamabad, Pakistan (enrolling)

Full record on ClinicalTrials.gov

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