Effect of Oxygenated Mouthwash and Mouth Foam
- Conditions
- Gingival DiseasesPlaque, DentalQuality of Life
- Interventions
- Other: Oxygenated MouthwashOther: Oxygenated mouth foam
- Registration Number
- NCT06079307
- Lead Sponsor
- King's College London
- Brief Summary
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
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).
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 60
- Students and employees at College of applied Medical science over 19 years old
- Both Saudis and non-Saudis.
- Students and employees consenting to participate.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oxygenated mouthwash Group Oxygenated Mouthwash Provided with oxygenated mouthwash bottle 2 per individual for 3 months (40 bottles in total). -20 participants - Oxygenated mouth foam Group Oxygenated mouth foam Provided with oxygenated mouth foam/ day- 20 participants- 2 oxygenated mouth foam bottle per individual for 3 months (40 bottles in total).
- Primary Outcome Measures
Name Time Method Gingival index +12 weeks from baseline 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.
Plaque index +12 weeks from baseline Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
- Secondary Outcome Measures
Name Time Method Gum Health Experience Questionnaire (GHEQ) +12 weeks from baseline 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)
Trial Locations
- Locations (1)
Haya Mahmmod Alayadi
🇸🇦Riyadh, Saudi Arabia