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, 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
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Crossover
Treatments tested in this trial
complete dentures
DeviceParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
General satisfaction
VAS score comparison between palatal contours
Secondary outcomes
Satisfaction with eating, taste, speech, phonetics, ease of cleaning
OHIP
Sponsors and contacts
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Pakistan Institute of Medical Sciences
Lead sponsor
Shaheed Zulfiqar Ali Bhutto Medical University
Sponsor institution
School of dentistry
Collaborator
Shaheed Zulfiqar Ali Bhutto Medical University Islamabad Pakistan
Collaborator