A Phase 2 interventional study of Camellia sinensis mouthwash and Placebo mouthwash in Gingivitis and Halitosis, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-07-22.
Sponsored by Mahidol University · Phase 2, Interventional, and Treatment
The purpose of this study is to determine effect of Mouthwash containing Camellia sinensis extracts on oral malodor and gingival inflammation in gingivitis subjects.
At baseline, level of volatile sulfur compounds (VSC) in mouth air, Plaque Index and Papillary Bleeding Index will be recorded. Gingivitis subjects will be asked to rinse with Camellia sinensis mouthwash or placebo mouthwash. VSC level will be measured at 30 minutes and 3 hours post-rinsing. For the following 4 weeks, subjects will be rinsed with the assigned mouthwash twice daily after toothbrushing. All parameter will be recorded again at Day 28.
590 studies on the registry are indexed under Gingivitis; 104 are open to participants now.
This study's planned enrollment of 60 is close to the median of 64 across 478 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.
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Exclusion Criteria:
Mouthwash A: Camellia sinensis mouthwash
Drug: Camellia sinensis mouthwash
Mouthwash B: Placebo mouthwash
Drug: Placebo mouthwash
mouthrinsing, 2 times/day, for 28 days
Also known as: Green tea mouthwash
mouthrinsing, 2 times/day, for 28 days
Also known as: placebo
level of volatile sulfur compounds in mouth air (part per billion)
Time frame: baseline, 30 minutes, 3 hours, 28 days
Papillary bleeding index
Time frame: baseline, 28 days
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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Mahidol University