NCT06079307

Effect of Oxygenated Mouthwash and Mouth Foam

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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).

Conditions

• Gingival Diseases
• Plaque, Dental
• Quality of Life

Interventions

Type	Name	Description
OTHER	Oxygenated Mouthwash	Will be comparing the impact of using oxygenated mouthwash with other groups.
OTHER	Oxygenated mouth foam	will be comparing the impact of using oxygenated foam to other groups.

Timeline

• Start date: 2023-10-01
• Primary completion: 2024-01-01
• Completion: 2024-01-01
• First posted: 2023-10-12
• Last updated: 2023-10-18

Locations

1 site across 1 country: Saudi Arabia