A Phase 2 interventional study of complete dentures in Edentulism, sponsored by Pakistan Institute of Medical Sciences. Recruiting at 1 site in Pakistan. Open to participants aged 40 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Pakistan Institute of Medical Sciences · Phase 2, Interventional, and Treatment
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.
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
Pakistan Institute of Medical Sciences is the lead sponsor of 51 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
EXCLUSION CRITERIA
Received maxillary complete denture with palatal rugae first, followed by a smooth polished palatal surface denture after a 2-month adaptation period.
Device: complete dentures
Received a smooth polished palatal surface denture first, followed by a rugae-enhanced denture after a 2-month adaptation period.
Device: complete dentures
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.
General satisfaction
VAS score comparison between palatal contours
Time frame: 2 months
Satisfaction with eating, taste, speech, phonetics, ease of cleaning
OHIP
Time frame: 2 months
Plan to share: Undecided
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Pakistan Institute of Medical Sciences