The Impact of Palatal Rugae Addition to Complete Dentures on Patients' Satisfaction and Oral Health Related Quality of Life
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: complete dentures.
- Who it may be relevant to
- Registry conditions: Edentulism. Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Impact of Palatal Rugae Addition to Complete Dentures on Patients' Satisfaction and Oral Health Related Quality of Life: A Randomized Crossover Clinical Trial
Overview
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.
Detailed description
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
• To compare conventional complete maxillary dentures with a smooth, polished palatal surface to those incorporating anatomical palatal rugae, in terms of patient-reported outcomes and oral health-related quality of life.
Interventions
- 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.
Primary outcome measures
- General satisfaction [Time frame: 2 months]
Secondary outcome measures (1)
- Satisfaction with eating, taste, speech, phonetics, ease of cleaning [Time frame: 2 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- School of Dentistry, SZABMU — Islamabad
Identifiers
NCT: NCT07034079 · SOD/12345