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

Recruiting Phase 2 Interventional Study
Edentulism
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial. Healthy Volunteers Welcome You do not need to have the condition being studied to take part.
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At a Glance
Age
40 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Pakistan Institute of Medical Sciences · Government
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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,…
Trial Locations
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Eligibility Criteria
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) * Patie…
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