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

NCT07034079 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: SOD/12345
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Edentulism

Keywords

Palatal rugae; Oral health impact profile; Edentulism; complete denture

Outcome Measures

Primary Outcomes (1)

• General satisfaction

  VAS score comparison between palatal contours

  2 months

Secondary Outcomes (1)

• Satisfaction with eating, taste, speech, phonetics, ease of cleaning

  2 months

Study Arms (2)

with palatal rugae initially

EXPERIMENTAL

Received maxillary complete denture with palatal rugae first, followed by a smooth polished palatal surface denture after a 2-month adaptation period.

Device: complete dentures

without palatal rugae initially

EXPERIMENTAL

Received a smooth polished palatal surface denture first, followed by a rugae-enhanced denture after a 2-month adaptation period.

Device: complete dentures

Interventions

complete dentures DEVICE

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.

with palatal rugae initially; without palatal rugae initially

Eligibility Criteria

• Age: 40 Years - 80 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pakistan Institute of Medical Sciences: lead
• School of dentistry: collaborator

MeSH Terms

Interventions

Denture, Complete

Intervention Hierarchy (Ancestors)

Dentures; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: August 1, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: June 24, 2025

Record last verified: 2025-06