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The Importance of Mucosal Screening in the Prevention of Oral Cancer.

2026年6月30日 更新者:Marta Sawczuk、Medical University of Warsaw

Patients attending the Department of Oral Mucosal and Periodontal Diseases at the University Dental Center of the Medical University of Warsaw who provide written informed consent will be invited to participate in the study.

Participation will begin with completing a short, anonymous questionnaire. The questions will focus on factors that may increase the risk of developing oral potentially malignant disorders and oral cancer, such as tobacco use, alcohol consumption, dietary habits, chronic diseases, and other health-related information.

Next, a comprehensive oral examination will be performed by a qualified dental hygienist according to a standardized examination protocol. The examination will include assessment of the lips, cheeks, gums, hard and soft palate, tongue, floor of the mouth, and throat. The oral mucosa will be evaluated for its appearance, colour, moisture, and the presence of any abnormalities, such as white or red patches, ulcers, erosions, nodules, or other lesions. A palpation examination of selected lymph nodes in the head and neck region will also be performed.

During the visit, oral hygiene will be assessed using an oral hygiene index. The condition of the teeth and any prosthetic restorations will also be evaluated to identify areas where dental plaque may accumulate or where chronic irritation of the oral mucosa may occur.

The final stage of the examination will involve assessment of the oral mucosa using the Oralitest fluorescence device. This is a painless, non-invasive procedure that uses light of a specific wavelength to examine the oral mucosa. The examination takes only a few minutes, requires no special preparation, and the device does not come into direct contact with the oral tissues. Healthy oral mucosa emits a characteristic green fluorescence, whereas areas that may require further investigation appear as darker regions. The result of the fluorescence examination is available immediately after the procedure.

調査の概要

詳細な説明

The study will be conducted among patients who consent to complete the questionnaire and participate in the study-those who visit the Department of Oral Mucosal and Periodontal Diseases at the University Dental Center of the Medical University of Warsaw for the prevention and treatment of oral mucosal and periodontal diseases. Each participant will be asked to complete a proprietary questionnaire designed for the study, consisting of questions regarding risk factors for potentially neoplastic lesions and oral cancer

. Subsequently, the following examinations will be conducted sequentially: a conventional external and intraoral examination, and an examination of the oral mucosa using fluorescence methods with the selected Oralitest device. A curing light is required to perform the fluorescence method. When epithelial tissue is exposed to light of a specific wavelength, fluorescence examination can reveal changes in its structure-down to the basement membrane, where precancerous lesions typically originate. This allows for the clear distinction of diseased, altered tissue, which appears as a darkened, irregular area, sharply contrasting with the healthy background that reflects light with a characteristic bright color. Both the clinical examination and the fluorescence examination will be conducted by a single dental hygienist-the project author-according to a specific, standardized protocol covering the labial red and individual parts of the oral mucosa (mucosa of the lips, cheeks, hard and soft palate, gums, oropharynx, tongue, and floor of the mouth). In the clinical examination, the mucosa will be assessed for color, moisture, and the presence of the following lesions: spot/stain (white, red, purple, black), papule, nodule, tumor, blister, vesicle, bulla, pustule, abrasion, erosion, fissure, ulcer, scale, scab, scar. A lymph node palpation examination will also be conducted according to a specific protocol: preauricular nodes, parotid nodes, paratracheal node, submandibular nodes. To assess oral hygiene, the API index will be determined, and the dentition and prosthetic restorations will be evaluated for areas where bacterial plaque can accumulate and for factors that irritate the mucous membrane. During the examination using fluorescence methods with the Oralitest device, the mucosa will be assessed for the presence of lesions that may suggest dysplasia-dark, irregular, often asymmetrical spots clearly contrasting with healthy, green-glowing tissue. The presence of lesions, their location and size, or any deviations from normal tissue fluorescence will be recorded in the oral mucosa examination chart. Patients in whom potentially malignant neoplastic changes are detected will be immediately referred for consultation with a periodontist.

研究の種類

介入

入学 (推定)

1383

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

    • Masovian Voivodeship
      • Warsaw、Masovian Voivodeship、ポーランド、02-091
        • Medical University of Warsaw

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:

  • 18 years of age or older

Exclusion Criteria:

  • under 18 years of age
  • patients with diagnosed and actively treated OPMD-related lesions.

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:診断
  • 割り当て:なし
  • 介入モデル:単一グループの割り当て
  • 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:Adult Patients Attending Routine Oral Mucosal Examination
Adult participants (≥18 years) consecutively recruited from patients attending the Department of Oral Mucosal Diseases and Periodontology, University Dental Center, Medical University of Warsaw, for the prevention and treatment of oral mucosal and periodontal diseases. Participants with previously diagnosed and actively treated oral potentially malignant disorders (OPMD) will be excluded. All participants will complete a study-specific questionnaire assessing risk factors for OPMD and oral cancer and will undergo both conventional clinical oral examination and fluorescence screening oral examination. Based on questionnaire responses, participants will subsequently be classified into high-risk and low-risk categories for secondary analyses; however, all participants will undergo the same study procedures.

Oral Fluorescence Examination Fluorescent oral examination (FOE) - an intraoral examination - was conducted by a single dental hygienist (the study author) according to a predetermined protocol. Intraorally: the examination areas are identical to those in the COE intervention-the red of the lips, as well as specific areas of the oral mucosa (mucosa of the lips, cheeks, hard and soft palate, gums, alveolar ridge, tongue, and floor of the mouth). The mucosa will be examined for the presence of lesions that may suggest dysplasia-dark, irregular, often asymmetrical patches that stand out distinctly from the healthy, green-glowing tissue.

This allows for the clear distinction of diseased, altered tissue-which appears as a darkened, irregular area-from the healthy background, which reflects light with its characteristic bright color.

Conventional oral examination (COE)-including conventional external and intraoral examinations-was conducted by a single researcher, a dental hygienist and the author of the study, according to a predetermined, standardized protocol. Extroral: examination of lymph node palpability at the following sites: preauricular nodes, retroauricular nodes, parauricular node, and submandibular nodes. Intraoral: examination of the mucosal membranes of the lips, cheeks, hard and soft palate, gums, oral cavity floor, and tongue, as well as the presence of lesions (spots/patches-white, red, purple, black). In clinical material, the mucous membrane reveals the location, moisture level, and presence of lesions: spot/stain (white, red, purple, black), papule, nodule, tumor, blister, vesicle, bubble, pustule, abrasion, erosion, fissure, ulcer, scale, scab, scar. In order to implement corrective measures that may result in API effects.

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
presence of OPMD (Oral Potentially Malignant Disorders)
時間枠:From the start of the conventional examination until the completion of the subsequent fluorescence examination-all during the same visit.
detection of abnormalities on the oral mucosa: white, red, or white-and-red lesions classified as Oral Potentially Malignant Disorders.
From the start of the conventional examination until the completion of the subsequent fluorescence examination-all during the same visit.

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。

捜査官

  • 主任研究者:Marta Sawczuk, MPH、Warszawski Uniwersytet Medyczny - Doktorant

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 (推定)

2026年6月1日

一次修了 (推定)

2027年8月31日

研究の完了 (推定)

2027年10月30日

試験登録日

最初に提出

2026年6月25日

QC基準を満たした最初の提出物

2026年6月30日

最初の投稿 (実際)

2026年7月6日

学習記録の更新

投稿された最後の更新 (実際)

2026年7月6日

QC基準を満たした最後の更新が送信されました

2026年6月30日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

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

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