School of Dentistry, SZABMU
Islamabad, 44000, Pakistan
Location status: Recruiting
NCT Number: NCT07034079
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.
Interested in participating?
Request Info40 year–80 year
All sexes
Interventional
Phase 2
Islamabad, 44000, Pakistan
Location status: Recruiting
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
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants were randomly allocated into two intervention sequences using a computer-generated randomization list. The two sequences were:
Time frame: 2 months
VAS score comparison between palatal contours
Time frame: 2 months
OHIP
Pakistan Institute of Medical Sciences
Other Gov
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
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