Clinical trial NCT06079307: Effect of Oxygenated Mouthwash and Mouth Foam
Official title: Effect of Oxygenated Mouthwash and Mouth Foam on Oral Health and Quality of Life
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Diseases
Plaque, Dental
Quality of Life
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: King Saud University
First posted: 2023-10-12
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 parallel arms running for 12 months and six-points data collection (examination - plaque index and gingival index)
Primary purpose: OTHER

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Gingival index
timeFrame: baseline
measure: Gingival index
timeFrame: +1 week from baseline
measure: Gingival index
timeFrame: +2 weeks from baseline
measure: Gingival index
timeFrame: +4 weeks from baseline
measure: Gingival index
timeFrame: +8 weeks from baseline
measure: Gingival index
timeFrame: +12 weeks from baseline
measure: Plaque index
timeFrame: baseline
measure: Plaque index
timeFrame: +1 week from baseline
measure: Plaque index
timeFrame: +2 weeks from baseline
measure: Plaque index
timeFrame: +4 weeks from baseline
measure: Plaque index
timeFrame: +8 weeks from baseline
measure: Plaque index
timeFrame: +12 weeks from baseline
Secondary outcomes:
measure: Gum Health Experience Questionnaire (GHEQ)
timeFrame: Baseline
measure: Gum Health Experience Questionnaire (GHEQ)
timeFrame: +12 weeks from baseline
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Haya Mahmmod Alayadi
Study officials:
affiliation: King Saud University
name: Haya M Alayadi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Allen F, Locker D. A modified short version of the oral health impact profile for assessing health-related quality of life in edentulous adults. Int J Prosthodont. 2002 Sep-Oct;15(5):446-50.
citation: Ciancio SG. Current status of indices of gingivitis. J Clin Periodontol. 1986 May;13(5):375-8, 381-2. doi: 10.1111/j.1600-051x.1986.tb01476.x.
citation: Fischman SL. Current status of indices of plaque. J Clin Periodontol. 1986 May;13(5):371-4, 379-80. doi: 10.1111/j.1600-051x.1986.tb01475.x.
citation: Broomhead T, Gibson BJ, Parkinson C, Robinson PG, Vettore MV, Baker SR. Development and psychometric validation of the gum health experience questionnaire. J Clin Periodontol. 2024 Jan;51(1):33-42. doi: 10.1111/jcpe.13878. Epub 2023 Sep 21.
citation: Broomhead T, Gibson B, Parkinson CR, Vettore MV, Baker SR. Gum health and quality of life-subjective experiences from across the gum health-disease continuum in adults. BMC Oral Health. 2022 Nov 18;22(1):512. doi: 10.1186/s12903-022-02507-5.