Gingival DiseasesNCT06079307
Effect of Oxygenated Mouthwash and Mouth Foam
A study testing Oxygenated Mouthwash and Oxygenated mouth foam in people with Gingival Diseases and Plaque, Dental, run by King's College London at 1 site in Saudi Arabia.
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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gingival Diseases, Plaque, Dental, Quality of Life
- What is being tested?
- Oxygenated Mouthwash and Oxygenated mouth foam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Oct 2023to 1 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Students and employees at College of applied Medical science over 19 years old
- Both Saudis and non-Saudis.
- Students and employees consenting to participate.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- 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).
- Intervention Group B: Oxygenated mouth foam/ day 20 participants- 2 oxygenated mouth foam bottle per individual for 3 months (40 bottles in total).
- Conditions
- Gingival Diseases, Plaque, Dental, Quality of Life
- Being tested
- Oxygenated Mouthwash, Oxygenated mouth foam
- Medical subject headings
- Gingival Diseases, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygenated MouthwashOther
Will be comparing the impact of using oxygenated mouthwash with other groups.
Oxygenated mouth foamOther
will be comparing the impact of using oxygenated foam to other groups.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Won't receive an oxygenated mouthwash nor oxygenated mouth foam yet will be provided a fluoridated toothpaste and a toothbrush (20 participants) |
| Oxygenated mouthwash Group | Experimental | Provided with oxygenated mouthwash bottle 2 per individual for 3 months (40 bottles in total). -20 participants - Receives: Other: Oxygenated Mouthwash |
| Oxygenated mouth foam Group | Experimental | Provided with oxygenated mouth foam/ day- 20 participants- 2 oxygenated mouth foam bottle per individual for 3 months (40 bottles in total). Receives: Other: Oxygenated mouth foam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: +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.
Measured: +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.
Measured: +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.
Measured: +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.
Measured: +12 weeks from baseline
Plaque index
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation.
Measured: baseline
Plaque index
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
Measured: +1 week from baseline
Plaque index
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
Measured: +2 weeks from baseline
Plaque index
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
Measured: +4 weeks from baseline
Plaque index
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
Measured: +8 weeks from baseline
Plaque index
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
Measured: +12 weeks from baseline
Secondary outcomes (2)
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)
Measured: 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)
Measured: +12 weeks from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start1 Oct 2023
- Primary completion1 Jan 2024 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gingival DiseasesStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 parallel arms running for 12 months and six-points data collection (examination - plaque index and gingival index)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- King Saud University
- Responsible party
- Sponsor
- Investigators
- Haya M Alayadi, PhD, Principal investigator, King Saud University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06079307
- Sponsor's protocol ID
- E-23- KSU-1001
- Status last verified
- May 2023
- First submitted
- 19 May 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
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.
PubMed 12375458Ciancio 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.
PubMed 3522646Fischman 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.
PubMed 3013947Broomhead 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.
PubMed 37735867Broomhead 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.
PubMed 36401324Talakey A, Alayadi H. Psychometric properties of the gum health experience questionnaire among adults in Saudi Arabia: Assessment of reliability and criterion validity. Community Dent Health. 2026 Oct 21:265539X261501681. doi: 10.1177/0265539X261501681. Online ahead of print.
PubMed 42905130
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Oxygenated Mouthwash and Mouth Foam on Oral Health and Quality of Life
- ClinicalTrials.gov ID
- NCT06079307
- Acronym / sponsor ID
- E-23- KSU-1001
- Conditions
- Gingival Diseases, Plaque, Dental, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- King Saud University
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 1 Jan 2024 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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).
- Intervention Group B: Oxygenated mouth foam/ day 20 participants- 2 oxygenated mouth foam bottle per individual for 3 months (40 bottles in total).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 3 parallel arms running for 12 months and six-points data collection (examination - plaque index and gingival index)
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Won't receive an oxygenated mouthwash nor oxygenated mouth foam yet will be provided a fluoridated toothpaste and a toothbrush (20 participants) |
| Oxygenated mouthwash Group | Experimental | Other: Oxygenated MouthwashProvided with oxygenated mouthwash bottle 2 per individual for 3 months (40 bottles in total). -20 participants - |
| Oxygenated mouth foam Group | Experimental | Other: Oxygenated mouth foamProvided with oxygenated mouth foam/ day- 20 participants- 2 oxygenated mouth foam bottle per individual for 3 months (40 bottles in total). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Students and employees at College of applied Medical science over 19 years old
- Both Saudis and non-Saudis.
- Students and employees consenting to participate.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygenated MouthwashWill be comparing the impact of using oxygenated mouthwash with other groups. | Other | Oxygenated mouthwash Group |
| Oxygenated mouth foamwill be comparing the impact of using oxygenated foam to other groups. | Other | Oxygenated mouth foam Group |
Primary outcome
Gingival index
Time frame: 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.
Gingival index
Time frame: +1 week from 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.
Gingival index
Time frame: +2 weeks from 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.
Gingival index
Time frame: +4 weeks from 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.
Gingival index
Time frame: +8 weeks from 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.
Gingival index
Time frame: +12 weeks from 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
Time frame: baseline
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation.
Plaque index
Time frame: +1 week from baseline
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
Plaque index
Time frame: +2 weeks from baseline
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
Plaque index
Time frame: +4 weeks from baseline
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
Plaque index
Time frame: +8 weeks from baseline
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
Plaque index
Time frame: +12 weeks from baseline
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
2 secondary outcomes
Gum Health Experience Questionnaire (GHEQ)
Time frame: Baseline
Gum Health Experience Questionnaire (GHEQ)
Time frame: +12 weeks from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Background: PubMed 12375458Allen 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.
- Background: PubMed 3522646Ciancio 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.
- Background: PubMed 3013947Fischman 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.
- Background: PubMed 37735867Broomhead 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.
- Background: PubMed 36401324Broomhead 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.
- Derived from this study: PubMed 42905130Talakey A, Alayadi H. Psychometric properties of the gum health experience questionnaire among adults in Saudi Arabia: Assessment of reliability and criterion validity. Community Dent Health. 2026 Oct 21:265539X261501681. doi: 10.1177/0265539X261501681. Online ahead of print.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haya M Alayadi, PhD principal investigator
King Saud University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygenated Mouthwash and Oxygenated mouth foam in people with Gingival Diseases and Plaque, Dental, run by King's College London at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival index (time frame: baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06079307, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.