- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07682883
The Importance of Mucosal Screening in the Prevention of Oral Cancer.
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, 폴란드, 02-091
- Medical University of Warsaw
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 18 years of age or older
Exclusion Criteria:
- under 18 years of age
- patients with diagnosed and actively treated OPMD-related lesions.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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presence of OPMD (Oral Potentially Malignant Disorders)
기간: From the start of the conventional examination until the completion of the subsequent fluorescence examination-all during the same visit.
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detection of abnormalities on the oral mucosa: white, red, or white-and-red lesions classified as Oral Potentially Malignant Disorders.
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From the start of the conventional examination until the completion of the subsequent fluorescence examination-all during the same visit.
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공동 작업자 및 조사자
수사관
- 수석 연구원: Marta Sawczuk, MPH, Warszawski Uniwersytet Medyczny - Doktorant
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- KB/53/2024
- WLS5/1/Z/MB/N/25/26 (기타 보조금/기금 번호: Medical Univerisity of Warsaw)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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