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

2026年5月7日 更新者: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.

調査の概要

詳細な説明

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.

研究の種類

介入

入学 (推定)

90

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Sindh
      • Karachi、Sindh、パキスタン、75500
        • 募集
        • Dow University of Health Sciences, Karachi
        • コンタクト:
        • 主任研究者:
          • Aqsa saeed Aqsa Saeed Khan, bds

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

はい

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:支持療法
  • 割り当て:ランダム化
  • 介入モデル:並列代入
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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.
実験的: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.
実験的: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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Patient satisfaction measured by Visual Analog Scale (VAS) at 3 months after insertion of complete dentures
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Oral health-related quality of life measured by OHIP-EDENT score at 3 months after insertion of complete dentures with different palatal rugae designs.
時間枠: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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年10月20日

一次修了 (推定)

2026年9月30日

研究の完了 (推定)

2026年12月30日

試験登録日

最初に提出

2026年1月7日

QC基準を満たした最初の提出物

2026年5月7日

最初の投稿 (実際)

2026年5月12日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月12日

QC基準を満たした最後の更新が送信されました

2026年5月7日

最終確認日

2025年10月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 65310

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

米国で製造され、米国から輸出された製品。

いいえ

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