Effect of Oxygenated Mouthwash and Mouth Foam

King's College London

Status: Active, not recruiting

Conditions: Quality of Life; Gingival Diseases; Plaque, Dental

Treatments: Other: Oxygenated Mouthwash; Other: Oxygenated mouth foam

Study type: Interventional

Funder types: Other

Identifiers

NCT06079307

E-23- KSU-1001

Details and patient eligibility

About

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.

Full 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).

2. Intervention Group B: Oxygenated mouth foam/ day 20 participants- 2 oxygenated mouth foam bottle per individual for 3 months (40 bottles in total).

Enrollment: 60 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 3 patient groups

Control

No Intervention group

Description:

Won't receive an oxygenated mouthwash nor oxygenated mouth foam yet will be provided a fluoridated toothpaste and a toothbrush (20 participants)

Oxygenated mouthwash Group

Experimental group

Description:

Provided with oxygenated mouthwash bottle 2 per individual for 3 months (40 bottles in total). -20 participants -

Treatment:

Other: Oxygenated Mouthwash

Oxygenated mouth foam Group

Experimental group

Description:

Provided with oxygenated mouth foam/ day- 20 participants- 2 oxygenated mouth foam bottle per individual for 3 months (40 bottles in total).

Treatment:

Other: Oxygenated mouth foam