Edentulism
Conditions
Keywords
Palatal rugae, Oral health impact profile, Edentulism, complete denture
Brief summary
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
DEVICEcomplete 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.
Sponsors
Pakistan Institute of Medical Sciences
School of dentistry
Shaheed Zulfiqar Ali Bhutto Medical University Islamabad Pakistan
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| General satisfaction | 2 months | VAS score comparison between palatal contours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with eating, taste, speech, phonetics, ease of cleaning | 2 months | OHIP |
Countries
Pakistan
Outcome results
None listed