Effect of Oxygenated Mouthwash and Mouth Foam

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06079307
• Other study ID #: E-23- KSU-1001
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: January 1, 2024

Study information

• Verified date: May 2023
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Plaque
• Gingival Diseases
• Plaque, Dental
• Quality of Life

Intervention

Other:
• Oxygenated Mouthwash
Will be comparing the impact of using oxygenated mouthwash with other groups.
• Oxygenated mouth foam
will be comparing the impact of using oxygenated foam to other groups.

Locations

Country	Name	City	State
Saudi Arabia	Haya Mahmmod Alayadi	Riyadh

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	King Saud University

Country where clinical trial is conducted

Saudi Arabia, 

References & Publications (5)

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. — View 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. — View 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. 2023 Sep 21. doi: 10.1111/jcpe.13878. Online ahead of print. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gingival index	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.	baseline
Primary	Gingival index	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.	+1 week from baseline
Primary	Gingival index	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.	+2 weeks from baseline
Primary	Gingival index	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.	+4 weeks from baseline
Primary	Gingival index	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.	+8 weeks from baseline
Primary	Gingival index	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.	+12 weeks from baseline
Primary	Plaque index	Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation.	baseline
Primary	Plaque index	Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation	+1 week from baseline
Primary	Plaque index	Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation	+2 weeks from baseline
Primary	Plaque index	Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation	+4 weeks from baseline
Primary	Plaque index	Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation	+8 weeks from baseline
Primary	Plaque index	Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation	+12 weeks from baseline
Secondary	Gum Health Experience Questionnaire (GHEQ)	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)	Baseline
Secondary	Gum Health Experience Questionnaire (GHEQ)	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)	+12 weeks from baseline