The Impact of Palatal Rugae Addition to Complete Dentures on Patients' Satisfaction and Oral Health Related Quality of Life: A Randomized Crossover Clinical Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- General satisfaction
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
with palatal rugae initially
Received maxillary complete denture with palatal rugae first, followed by a smooth polished palatal surface denture after a 2-month adaptation period.
Intervention: complete dentures (Device)
without palatal rugae initially
Received a smooth polished palatal surface denture first, followed by a rugae-enhanced denture after a 2-month adaptation period.
Intervention: complete dentures (Device)
Outcomes
Primary Outcomes
General satisfaction
Time Frame: 2 months
VAS score comparison between palatal contours
Secondary Outcomes
- Satisfaction with eating, taste, speech, phonetics, ease of cleaning(2 months)
Investigators
Chawla Rashmi
Resident
Shaheed Zulfiqar Ali Bhutto Medical University