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NCT07034079
The Impact of Palatal Rugae Addition to Complete Dentures on Patients' Satisfaction and Oral Health Related Quality of Life
Conditions: Edentulism
Sex: All
Ages: 40 Years – 80 Years
Healthy volunteers: Yes
Phase: PHASE2
Enrollment: 60
Sponsor: Pakistan Institute of Medical Sciences
Location: School of Dentistry, SZABMU Islamabad Islamabad
Summary
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
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
Source: ClinicalTrials.gov (NCT07034079). StuddyBuddy aggregates publicly available trial information.