The study is investigating the ability of Oil Pulling mouthwash to reduce the rate at which dental plaque is form on your teeth, resolve any gum inflammation (Gingivitis, and reduce the number of bacteria that are causing gum diseases. The Oil Pulling mouthwash will be compared with another Plaque Control mouthwash in the market and another mouthwash tat does not control plaque. Participants will be randomized (like toss of coin) into one of these mouthwashes. The researchers will not know the mouthwash a participant will be placed into. 120 adult participants with gum inflammation (gingivitis) will be recruited. The study duration will be 8 weeks with assessments at baseline, 4 weeks, and 8 weeks, so each participant will make three visits.
Razina Vohra
210-567-3385
vohrar@uthscsa.edu
Principal Investigator
Bennett Amaechi
Martrisha Trainum
210-450-7428
trainum@uthscsa.edu
1. Have a minimum of 20 'scorable' teeth (excluding 3rd molars).
2. The subjects should understand the information provided about the investigative nature of the treatment, possible benefits and side effects.
3. Subjects will sign the Informed Consent Form.
4. The subjects should be willing to comply with the study procedure and schedule, including the follow-up visits.
1 Current or history of oral cavity cancer or oropharyngeal cancer.
2 Subject with destructive periodontal disease or those on antibiotic or anti-inflammatory drugs.
3 Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body.
4 Pregnant or nursing by subject report.
5 Known allergic reaction to any of the study mouthwashes or any of their component.
6 Any active condition, including but not limited to advanced periodontal disease or severe gingival recession, in the oral cavity at the discretion of the investigator.
7 Any surgery or recent dental procedure in the oral cavity within 3 months prior to treatment, or before complete healing.
8 Subjects that do not brush regularly.
9 Any condition that might make it unsafe for the subject to participate in this study, at the discretion of the investigator.
10 History of allergy or hypersensitivity to mouthwash ingredients
11 Significant medical conditions, such as uncontrolled diabetes or immunosuppressive disorders
12 Use of tobacco products, including cigarettes and smokeless tobacco
13 Presence of orthodontic appliances, except for removable retainers
14 Participation in another clinical trial within the last 30 days.
15 Individuals unable to comply with study requirements, such as regular product use or scheduled visits.
16 Habitual use of alcohol or drugs that may affect compliance or oral health