Effect of Oxygenated Mouthwash and Mouth Foam

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2024-01-01

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.

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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).

Conditions

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Gingival Diseases Plaque, Dental Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

3 parallel arms running for 12 months and six-points data collection (examination - plaque index and gingival index)

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

due to ethical consideration participants cannot be blinded nor examiners as they will be providing oral hygiene instructions and information relative to using the mouth rinse and the mouth foam. everyone handling the data after examination will be blinded, they will be dealing with data obtained after identifying an identification code to each participant.

Study Groups

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Control

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Oxygenated mouthwash Group

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

Group Type EXPERIMENTAL

Oxygenated Mouthwash

Intervention Type OTHER

Will be comparing the impact of using oxygenated mouthwash with other groups.

Oxygenated mouth foam Group

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

Group Type EXPERIMENTAL

Oxygenated mouth foam

Intervention Type OTHER

will be comparing the impact of using oxygenated foam to other groups.

Interventions

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Oxygenated Mouthwash

Will be comparing the impact of using oxygenated mouthwash with other groups.

Intervention Type OTHER

Oxygenated mouth foam

will be comparing the impact of using oxygenated foam to other groups.

Intervention Type OTHER

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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes