Effect of Oxygenated Mouthwash and Mouth Foam

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Quality of Life; Gingival Diseases; Plaque, Dental
• Intervention / Treatment: Other: Oxygenated Mouthwash; Other: Oxygenated mouth foam

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).

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh, Saudi Arabia, 4312
    • Haya Mahmmod Alayadi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Won't receive an oxygenated mouthwash nor oxygenated mouth foam yet will be provided a fluoridated toothpaste and a toothbrush (20 participants)
Experimental: Oxygenated mouthwash Group; Provided with oxygenated mouthwash bottle 2 per individual for 3 months (40 bottles in total). -20 participants -	Other: Oxygenated Mouthwash; Will be comparing the impact of using oxygenated mouthwash with other groups.
Experimental: 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).	Other: Oxygenated mouth foam; will be comparing the impact of using oxygenated foam to other groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plaque index	Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation	+1 week from baseline
Plaque index	Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation	+2 weeks from baseline
Plaque index	Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation	+4 weeks from baseline
Plaque index	Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation	+8 weeks from baseline
Plaque index	Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation	+12 weeks from baseline
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
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
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
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
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
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
Plaque index	Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: King's College London
• Collaborators: King Saud University
• Investigators: Principal Investigator: Haya M Alayadi, PhD, King Saud University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Estimated): January 1, 2024
• Study Completion (Estimated): January 1, 2024

Study Registration Dates

• First Submitted: May 19, 2023
• First Submitted That Met QC Criteria: October 5, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Tooth Diseases; Dental Deposits; Dental Plaque; Gingival Diseases
• Other Study ID Numbers: E-23- KSU-1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The principle investigator will be responsible for all data entry and management. Personal identification will be collected to regain contact with participants for the follow-up assessments and link baseline with follow-up data. This will be handled through pseudo anonymization, whereby the principle investigator will keep a separate file containing personal identifiable information for all participants and assign an identification code to each as they enter the study. Other than the examiner in the clinic everybody else will be working with coded data when analyzing the information.
• IPD Sharing Time Frame: upon the completion of the trial
• IPD Sharing Access Criteria: study protocol as well as statistical analysis plane will be shared through a published paper as well as reporting back to trials.gov and clinical study report will be shared through trials.gov
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No