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

Study acronym: Palatal rugae
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Recruitment openedv3
  2. Primary and study completion dates: Jan 31, 2026 to Dec 31, 2026
    • Start date: Aug 1, 2025 to Jul 1, 2026
    • Collaborators: 1 to 2
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07034079
Lead Sponsor Pakistan Institute of Medical Sciences
Collaborators: School of dentistry, Shaheed Zulfiqar Ali Bhutto Medical University Islamabad Pakistan
Conditions
(from sponsor)		 Edentulism
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov