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The Effect of Palatal Rugae Design in Complete Denture on Patient Satisfaction and Quality of Life

7 maggio 2026 aggiornato da: Dow University of Health Sciences

The goal of this clinical trial is to learn whether different palatal rugae designs in complete dentures can improve comfort, function, and overall oral health-related quality of life in edentulous adults aged 40 to 80 years. The main questions it aims to answer are:

Do roughened or vacuum-formed thermoplastic sheet palatal rugae designs lead to higher patient satisfaction than the traditional polished design?

Do these designs improve oral health-related quality of life, including chewing, speaking, and overall comfort?

Researchers will compare three denture designs-a polished palatal surface, a roughened palatal surface, and a vacuum-formed thermoplastic sheet rugae design-to see which design provides better comfort, function, and quality of life for patients.

Participants will:

Receive complete maxillary dentures made with one of the three palatal rugae designs

Attend follow-up assessments at 1 week, 1 month, and 3 months after denture insertion (in person or by phone)

Complete the OHIP-EDENT questionnaire and a Visual Analog Scale (VAS) to report satisfaction, comfort, and oral health-related quality of life.

Panoramica dello studio

Descrizione dettagliata

Edentulism, the complete loss of natural teeth, remains a significant public health concern due to its profound impact on oral function, speech, comfort, and psychosocial well-being. Although dental implants provide a favorable treatment option for many edentulous patients, financial limitations, medical contraindications, and inadequate bone structure often prevent their use. Consequently, conventional complete dentures continue to serve as the primary option for oral rehabilitation in a large proportion of patients.

In conventional maxillary complete dentures, the palatal surface plays an essential role in retention, support, and stability. However, full palatal coverage may also reduce tactile sensitivity and compromise patient comfort, speech clarity, and the ability to perceive taste and temperature. The natural palate contains palatal rugae-elevated folds rich in mechanoreceptors that contribute to oral proprioception and assist in guiding tongue movements during speech, swallowing, and mastication. In contrast, the palatal surface of a conventional denture is typically smooth, which may limit the tongue's ability to adapt effectively to the prosthesis.

Multiple techniques have been proposed to incorporate palatal rugae patterns into complete dentures, including tin-foil duplication, dental floss carving, silicone putty impressions, small palatal windows, roughening procedures, and vacuum-formed templates. While each method offers certain benefits, they also present limitations such as material instability, operator sensitivity, cost, or the need for additional laboratory steps. Previous research comparing polished, roughened, and open rugae designs has shown that designs with greater tactile feedback may improve user satisfaction and oral health-related quality of life (OHRQoL), whereas excessive modification-such as open rugae windows-may reduce comfort and function. Despite these findings, limited evidence is available regarding the comparative effectiveness of polished, roughened, and vacuum-formed thermoplastic rugae designs in maxillary complete dentures.

This randomized controlled trial aims to address this gap by evaluating how three different palatal rugae textures-polished, roughened, and vacuum-formed thermoplastic sheet-affect patient satisfaction and OHRQoL among complete denture wearers. Ninety participants will be randomly allocated into one of three groups. All dentures will be fabricated using standard clinical and laboratory protocols, with the only experimental variation occurring in the palatal rugae region.

The polished-surface group will receive dentures with a conventional smooth palatal surface finished with standard pumice polishing. The roughened-surface group will receive dentures in which the rugae area is textured using 120-µm aluminum oxide sandblasting at 2 bar for 10 seconds. The vacuum-formed group will receive dentures incorporating a rugae pattern created from a 0.5-mm thermoplastic sheet molded over a cast and transferred to the waxed denture before processing. These three designs represent accessible, commonly used techniques with potential clinical benefits in recreating natural palatal anatomy.

Participants will be evaluated at one week, one month, and three months after denture insertion. During each follow-up, participants will complete the OHIP-EDENT questionnaire to assess the impact of the denture on daily function, psychosocial well-being, and oral discomfort. A Visual Analog Scale (VAS) will also be used to measure subjective satisfaction with comfort, chewing, speech, esthetics, and overall denture experience. Clinical assessments will include denture fit, speech clarity, comfort, mucosal condition, and any necessary adjustments.

The primary outcome of the study is the difference in OHIP-EDENT scores among the three rugae design groups over time. Secondary outcomes include VAS-based satisfaction scores and patient-reported ease of adaptation. Through this structured comparison, the study aims to determine whether incorporating specific palatal rugae textures can improve comfort, enhance sensory feedback, aid speech articulation, and contribute positively to oral health-related quality of life.

Ultimately, this research seeks to inform evidence-based improvements in complete denture design, offering clinicians practical guidance for selecting palatal rugae configurations that enhance patient experience and long-term adaptation.

Tipo di studio

Interventistico

Iscrizione (Stimato)

90

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Sindh
      • Karachi, Sindh, Pakistan, 75500
        • Reclutamento
        • Dow University of Health Sciences, Karachi
        • Contatto:
        • Investigatore principale:
          • Aqsa saeed Aqsa Saeed Khan, bds

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Descrizione

Inclusion Criteria:

  1. Patients seeking conventional complete dentures.
  2. Aged 40-80 years.
  3. Both genders (male and female).
  4. Patient's must be willing to participate in the study and able to attend follow-up appointments

Exclusion Criteria:

  1. Patients with severe underlying medical conditions and mental conditions.
  2. Neuromuscular dysfunction.
  3. Oral diseases such as denture stomatitis and oral submucous fibrosis
  4. Xerostomia and tied tongue condition.
  5. Flabby and Atrophic Ridges.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Arm 1: Polished Palatal Surface Denture
Maxillary complete denture with a polished palatal surface. The denture is fabricated using standard clinical procedures without added rugae or texturing. This design is being compared with dentures having roughened palatal rugae or vacuum-formed thermoplastic sheet rugae to evaluate differences in patient satisfaction and oral health-related quality of life.
Maxillary complete denture with a traditional polished palatal surface. Fabricated using standard clinical procedures without added rugae or texturing. Serves as the control design in this study and will be compared with roughened and vacuum-formed thermoplastic sheet dentures to assess patient satisfaction, comfort, chewing ability, and oral health-related quality of life.
Sperimentale: Arm 2: Roughened Palatal Rugae Design
Maxillary complete denture with a roughened palatal rugae surface. The rugae are intentionally textured to improve tactile feedback, retention, and comfort. Participants receive standard denture fabrication and fitting procedures. This intervention is compared with polished and vacuum-formed thermoplastic sheet dentures to assess effects on patient satisfaction and oral health-related quality of life.
Maxillary complete denture with a roughened palatal rugae surface. Rugae are intentionally textured to enhance tactile feedback, retention, and comfort. Standard fabrication and fitting procedures are used. Compared with polished and vacuum-formed dentures to evaluate effects on patient satisfaction, comfort, chewing efficiency, and oral health-related quality of life.
Sperimentale: Arm 3: Vacuum-Formed Thermoplastic Rugae Denture
Maxillary complete denture with vacuum-formed thermoplastic sheet palatal rugae. The thermoplastic sheet replicates natural palatal rugae patterns, aiming to enhance denture retention, comfort, and chewing efficiency. Participants receive standard denture fabrication and fitting procedures. This intervention is compared with polished and roughened rugae dentures to evaluate patient satisfaction and oral health-related quality of life.
Maxillary complete denture with vacuum-formed thermoplastic sheet palatal rugae. The thermoplastic sheet replicates natural palatal rugae patterns to improve denture retention, comfort, and chewing efficiency. Participants receive standard denture fabrication and fitting. Compared with polished and roughened dentures to assess patient satisfaction, comfort, and oral health-related quality of life.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Patient satisfaction measured by Visual Analog Scale (VAS) at 3 months after insertion of complete dentures
Lasso di tempo: From enrolment to the end of treatment at 1 week, 3 weeks, 3 months
Patient satisfaction with maxillary complete dentures assessed using a Visual Analog Scale (VAS). Participants rate their overall satisfaction on a 100-mm line, where 0 indicates "not satisfied" and 100 indicates "totally satisfied." Higher scores indicate greater satisfaction.
From enrolment to the end of treatment at 1 week, 3 weeks, 3 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Oral health-related quality of life measured by OHIP-EDENT score at 3 months after insertion of complete dentures with different palatal rugae designs.
Lasso di tempo: From enrolment to the end of treatment at 1 week, 3 weeks, 3 months
Oral health-related quality of life will be assessed using the 20-item OHIP-EDENT questionnaire at 3 months post-insertion of complete dentures with polished, roughened, or vacuum-formed palatal rugae designs. Scores will range from 20 (best) to 100 (worst), with lower scores indicating better quality of life. This measure will evaluate the impact of different palatal rugae textures on patients' comfort, function, and overall oral health-related quality of life over time
From enrolment to the end of treatment at 1 week, 3 weeks, 3 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

20 ottobre 2025

Completamento primario (Stimato)

30 settembre 2026

Completamento dello studio (Stimato)

30 dicembre 2026

Date di iscrizione allo studio

Primo inviato

7 gennaio 2026

Primo inviato che soddisfa i criteri di controllo qualità

7 maggio 2026

Primo Inserito (Effettivo)

12 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 maggio 2026

Ultimo verificato

1 ottobre 2025

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 65310

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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