Gingival Diseases, Plaque, Dental, Quality of Life
Conditions
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).
Interventions
OTHEROxygenated Mouthwash
Will be comparing the impact of using oxygenated mouthwash with other groups.
OTHEROxygenated mouth foam
will be comparing the impact of using oxygenated foam to other groups.
Sponsors
King Saud University
King's College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
3 parallel arms running for 12 months and six-points data collection (examination - plaque index and gingival index)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gingival index | 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 | baseline | Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gum Health Experience Questionnaire (GHEQ) | 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) |
Countries
Saudi Arabia
Outcome results
None listed