Community-Based Screening for Oral Premalignant Lesions using Toluidine Blue dye staining – A Randomized Controlled Trial
Date Issued
2006
Date
2006
Author(s)
Su, Wang-yu
DOI
zh-TW
Abstract
[Background]
Oral squamous cell carcinoma is now the seventh highest type of malignancy in Taiwan. Incidence of oral cancer has continued to increase parallel to the consumption of betel quid since 1980s and with a similar but lesser extent of the consumption of tobacco. Long preclinical detectable phase in oral permalignant lesions (OPL), including oral submucous fibrosis, homogenous leukoplakia, non-homogenous leukoplakia, and erythroplakia, almost preceded the advent of clinical manifest oral cancer. Consequently, with proper screening, these OPLs could be detected early and proper intervention given, hence in hope of reducing incidence of oral cancer.
[Study Purpose]
(1) To assess whether oral screening with visual inspection with a supplement of Toulidine blue vital dye staining targeting at high risk group (betel quid chewing or smoking) can detect more oral premalignant lesions
(2) To quantify the disease natural history for oral cancer and performed a simulation for the cost-effectiveness analysis
[Designs and Methods]
A community-based randomized controlled trial was designed and conducted in Keelung City in northern Taiwan during 1999. Subjects aged no less than 15 years old with habit of smoking or betel quids chewing were enrolled and randomly assigned into two arms. The experiment group was screened with Toluidine blue dye oral gargling following by visual inspection by experienced oral surgeons. The control group had only placebo dye gargling following by visual inspection by the same blinded oral surgeons. If suspicious oral lesions were identified, referral to tertiary referral medical center for clinical diagnosis and biopsy was arranged. The pathologic report was used as the gold standard for definite diagnosis. Linkage to death registry databank until December 31, 2004 was made to acquire data on occurrence of oral cancer, status of survival and cause of death. Analysis was done on an intention to treat basis.
[Results]
Of the 8,101 eligible participants recruited in this study, one hundred and twenty-six participants were excluded in the analysis owing to incomplete data collection. A total of 4,080 (51.16%) individuals were included in the experiment group, and 3,895 (48.84%) individuals in the control group. Three hundred and eighty-nine subjects (9.53%) in the experiment group yielded positive screening result while 322 subjects (8.27%) in the control group. After excluding false positive subjects, the positive OPL detection rate was not statistical significant (p=0.64) between the experiment group (4.58%, 187/4,080) and the control group (4.36%, 170/3,895). In subgroup analysis, the detection rate ratio of submucous fibrosis was 1.81 (95%CI 1.05~3.12) between the experiment (41/4,080, 1%) and the control (22/389, 0.56%) group. The relative malignant transformation rate or OPL was 1.29×10-3 in the experiment group and 4.20×10-3 in the control group. The ratio between two groups was 3.25 (95%CI 0.34~31.23) which mean the experiment group tended to detect OPL with higher malignant transformation potential. As for the occurrence oral cancer, it was 11.3×10-5 in the experiment group and 18.45×10-5 in the control group.
[Conclusions]
The current study is the first one to demonstrate that under the aid of Toluidine blue dye vital staining, mass screening for the high risk subjects could not detect statistically significantly more OPL than screening with visual inspection. The experiment group (41/4,080, 1%) tended to has higher detection rate on oral submucous fibrosis than the control group (22/3,895, 0.56%, p=0.03). In terms of economics, it was a convenient, safe and cost-effective adjunct in mass screening for oral premalignant lesions. Further research with larger cohort or longer follow-up period should be considered to delineate the results more in depth.
Subjects
甲苯胺藍試劑
臨床隨機試驗
口腔黏膜癌前病變
口腔黏膜下纖維化
均質性白斑
非均質性白斑
紅斑
鱗狀細胞癌
惡性轉移率
Toluidine blue
randomized controlled trail
oral premalignant lesion
oral submucous fibrosis
homogenous leukoplakia
non-homogenous leukoplakia
erythroplakia
squamous cell carcinoma
malignant transformation rate
SDGs
Type
thesis
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