Effect of Oxygenated Mouthwash and Mouth Foam

Study Overview
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Brief Summary
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The Aim of this independent, parallel, twelve-week clinical study is to assess the efficacy of a commercially available oxygenated mouth rinse and mouth foam on both plaque level and gingival status in addition to assessing the oral health related quality of life.

Detailed Description
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Participants in all groups will be examined for gingival inflammation and plaque accumulation. The difference between three trial arms lies in the product used (control, oxygenated mouth wash, oxygenated mouth foam). A comparison against no intervention was disregarded due to ethical concerns (children only examined without informing them about their oral problems). After examination at baseline participants will be assigned to one arm of intervention. All participants will be provided an oral health education and gingival scaling to remove any underlining predisposing factor for gingival inflammation as well as fluoridated toothpaste and a toothbrush. Participants within intervention arms will also be provided the product package and informed how to use it (oxygenated mouth wash, oxygenated mouth foam). All three arms will be followed after (1week, 2 weeks, 4 weeks, 8 weeks and 12 weeks) from baseline examination. 1. Control group Won't receive an oxygenated mouthwash nor oxygenated mouth foam (20 participants) 2. Intervention Group A: 20 participants - 2 oxygenated mouthwash bottle per individual for 3 months (40 bottles in total). 3. Intervention Group B: Oxygenated mouth foam/ day 20 participants- 2 oxygenated mouth foam bottle per individual for 3 months (40 bottles in total).

Official Title
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Effect of Oxygenated Mouthwash and Mouth Foam on Oral Health and Quality of Life

Conditions
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Gingival Diseases, Plaque, Dental, Quality of Life

Intervention / Treatment
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* Other: Oxygenated Mouthwash
* Other: Oxygenated mouth foam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Students and employees at College of applied Medical science over 19 years old Both Saudis and non-Saudis. Students and employees consenting to participate. Exclusion Criteria: Intern students or students in their 1st year. Students and employees with medically compromised condition (including congenital heart disease, hematological condition, immune deficiency condition and end stage renal disease or those with organ transplant within the previous 5 year. Students and employees not consenting to participate.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 parallel arms running for 12 months and six-points data collection (examination - plaque index and gingival index)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Won't receive an oxygenated mouthwash nor oxygenated mouth foam yet will be provided a fluoridated toothpaste and a toothbrush (20 participants) | |
| Experimental: Oxygenated mouthwash Group<br>Provided with oxygenated mouthwash bottle 2 per individual for 3 months (40 bottles in total). -20 participants - | Other: Oxygenated Mouthwash<br>* Will be comparing the impact of using oxygenated mouthwash with other groups.<br>|
| Experimental: Oxygenated mouth foam Group<br>Provided with oxygenated mouth foam/ day- 20 participants- 2 oxygenated mouth foam bottle per individual for 3 months (40 bottles in total). | Other: Oxygenated mouth foam<br>* will be comparing the impact of using oxygenated foam to other groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival index | Gingival index has been used to clinically characterize the degree of gingival inflammation. were the scale range 0-3. zero indicating the best results and 3 as sever gingivitis. | baseline | 
| Gingival index | Gingival index has been used to clinically characterize the degree of gingival inflammation. were the scale range 0-3. zero indicating the best results and 3 as sever gingivitis. | +1 week from baseline | 
| Gingival index | Gingival index has been used to clinically characterize the degree of gingival inflammation. were the scale range 0-3. zero indicating the best results and 3 as sever gingivitis. | +2 weeks from baseline | 
| Gingival index | Gingival index has been used to clinically characterize the degree of gingival inflammation. were the scale range 0-3. zero indicating the best results and 3 as sever gingivitis. | +4 weeks from baseline | 
| Gingival index | Gingival index has been used to clinically characterize the degree of gingival inflammation. were the scale range 0-3. zero indicating the best results and 3 as sever gingivitis. | +8 weeks from baseline | 
| Gingival index | Gingival index has been used to clinically characterize the degree of gingival inflammation. were the scale range 0-3. zero indicating the best results and 3 as sever gingivitis. | +12 weeks from baseline | 
| Plaque index | Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation. | baseline | 
| Plaque index | Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation | +1 week from baseline | 
| Plaque index | Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation | +2 weeks from baseline | 
| Plaque index | Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation | +4 weeks from baseline | 
| Plaque index | Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation | +8 weeks from baseline | 
| Plaque index | Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation | +12 weeks from baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gum Health Experience Questionnaire (GHEQ) | The questions are designed to assess the impact that gum-related symptoms may have on your everyday life. (Assessed through Likert scale were the 5 is the highest score and 1 is the lowest score) | Baseline | 
| Gum Health Experience Questionnaire (GHEQ) | The questions are designed to assess the impact that gum-related symptoms may have on your everyday life. (Assessed through Likert scale were the 5 is the highest score and 1 is the lowest score) | +12 weeks from baseline |