The Prevalence of Gingival Pigmentation Among a Sample of Adult Egyptian Population.
2022年7月7日 更新者：Peter Onsi Doss Hanna、Cairo University
The Prevalence of Gingival Pigmentation Among a Sample of Adult Egyptian Population: A Cross Sectional Study.
This observational cross-sectional study aims at determining the prevalence of gingival pigmentation among a sample of adult Egyptian patients attending the diagnostic centre at Faculty of Dentistry, Cairo University and identifying its association with other risk factors.
研究概览
地位
尚未招聘
条件
详细说明
- Dental patients will be recruited in a consecutive manner from the diagnostic center, Faculty of Dentistry, Cairo University.
- Medical history will be taken and patients with certain diseases as Addison's disease, Albright's syndrome, Hereditary hemorrhagic telangiectasia, and HIV-associated melanosis or under certain drugs as ACTH, Antimalarial drugs, and Chemotherapeutic agent-busulfan that induce gingival pigmentation will be excluded from the study.
- Patients who met the inclusion criteria will be subjected to thorough oral examination and a full questionnaire will be filled for each patient. Before filling the questionnaire, the aim of the study will be explained to the patient and the patient's acceptance to participate in the survey will be received.
- During examining patients, any patient found with suspicious gingival pigmentation, whether the degree of pigmentation, texture, size, or any clinical signs of malignancy, will be referred to the Oral Medicine department for a thorough oral and lymph nodes examination, and biopsy taking if needed. Also, any other suspicious oral lesion noticed will be treated the same way, and a close follow-up for the patient will be done to ensure that the he/she has gone through all possible examination protocols to exclude any possibility of malignancy or abnormal condition that needs intervention.
- During oral examination of included patients, those will be found to have gingival pigmentation will be classified according to the gingival pigmentation index.
- Non-respondent patients or patients refusing to participate will be reported with the cause of their refusal.
- The Questionnaire will be filled through a face-to-face personal interview with the patient using simple, short, easily comprehended questions.
- The Questionnaire will include a section for information about age, gender, occupation, place of birth and current residential area.
- Detailed information about smoking type (cigarette, shisha, Vape, IQOS, or others), Smoking Frequency, Smoking duration (no. of years) will be gathered
- The degree of satisfaction or dissatisfaction with gingival pigmentation, and the willingness to do a surgical or laser procedure to change it will be evaluated by VAS score.
- Conventional oral examination will be held on a dental unit using the light of the unit.
研究类型
观察性的
注册 (预期的)
374
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
取样方法
非概率样本
研究人群
A sample of adult Egyptian patients attending the diagnostic centre at Faculty of Dentistry, Cairo University and identifying its association with other risk factors.
描述
Inclusion Criteria:
- Adult patients whose age is 18 years old and above.
- Patient consulting in the diagnostic centre, Faculty of Dentistry, Cairo University.
- Provide informed consent.
Exclusion Criteria:
- Systemic diseases and syndromes known to be associated with oral melanin pigmentation, such as Addison's disease, Albright's syndrome, Hereditary hemorrhagic telangiectasia, and HIV-associated melanosis (Peeran et al 2014).
- Patients taking certain drugs that predispose to drug-induced melanin pigmentation, such as: ACTH, Antimalarial drugs, and Chemotherapeutic agent-busulfan (Peeran et al 2014).
- Tattoos of the oral mucosa
- Patients having problem in opening their mouth or undergoing inter-maxillary fixation where oral examination will not be possible.
- Patients diagnosed with psychiatric problems.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
|---|
|
A sample of adult egyptian population
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Prevalence of gingival pigmentation
大体时间：Up to 30 weeks
|
Gingival Pigmentation Index which classified pigmentation into 4 scores according to the position and extent of the gingival pigments:
|
Up to 30 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Age of the participant associated risk factors
大体时间：Up to 30 weeks
|
Age in years
|
Up to 30 weeks
|
|
Gender of the participant
大体时间：Up to 30 weeks
|
Male or female
|
Up to 30 weeks
|
|
Occupation of the participant
大体时间：Up to 30 weeks
|
Certain occupations may be a possible risk factor
|
Up to 30 weeks
|
|
Type of smoking
大体时间：Up to 30 weeks
|
Cigarette, shisha, Vape, IQOS,… etc. certain types may be of variable risk factor
|
Up to 30 weeks
|
|
Frequency of smoking
大体时间：Up to 30 weeks
|
Number of Cigarettes/day, In case of other types: daily, weekly, twice weekly, monthly
|
Up to 30 weeks
|
|
Duration of smoking
大体时间：Up to 30 weeks
|
In years
|
Up to 30 weeks
|
|
Place of birth
大体时间：Up to 30 weeks
|
City of birth
|
Up to 30 weeks
|
|
Current area of residence
大体时间：Up to 30 weeks
|
City of residence
|
Up to 30 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2022年10月1日
初级完成 (预期的)
2023年1月15日
研究完成 (预期的)
2023年6月15日
研究注册日期
首次提交
2022年7月2日
首先提交符合 QC 标准的
2022年7月7日
首次发布 (实际的)
2022年7月12日
研究记录更新
最后更新发布 (实际的)
2022年7月12日
上次提交的符合 QC 标准的更新
2022年7月7日
最后验证
2022年7月1日
更多信息
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- POD 1
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