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Effect of Oxygenated Mouthwash and Mouth Foam

Primary Purpose

Gingival Diseases, Plaque, Dental, Quality of Life

Status
Active
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Oxygenated Mouthwash
Oxygenated mouth foam
Sponsored by
King's College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gingival Diseases

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Haya Mahmmod Alayadi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

Oxygenated mouthwash Group

Oxygenated mouth foam Group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
Plaque index
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation.
Plaque index
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
Plaque index
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
Plaque index
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
Plaque index
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
Plaque index
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation

Secondary Outcome Measures

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)
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)

Full Information

First Posted
May 19, 2023
Last Updated
October 16, 2023
Sponsor
King's College London
Collaborators
King Saud University
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1. Study Identification

Unique Protocol Identification Number
NCT06079307
Brief Title
Effect of Oxygenated Mouthwash and Mouth Foam
Official Title
Effect of Oxygenated Mouthwash and Mouth Foam on Oral Health and Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King's College London
Collaborators
King Saud University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Diseases, Plaque, Dental, Quality of Life

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 parallel arms running for 12 months and six-points data collection (examination - plaque index and gingival index)
Masking
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.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Won't receive an oxygenated mouthwash nor oxygenated mouth foam yet will be provided a fluoridated toothpaste and a toothbrush (20 participants)
Arm Title
Oxygenated mouthwash Group
Arm Type
Experimental
Arm Description
Provided with oxygenated mouthwash bottle 2 per individual for 3 months (40 bottles in total). -20 participants -
Arm Title
Oxygenated mouth foam Group
Arm Type
Experimental
Arm Description
Provided with oxygenated mouth foam/ day- 20 participants- 2 oxygenated mouth foam bottle per individual for 3 months (40 bottles in total).
Intervention Type
Other
Intervention Name(s)
Oxygenated Mouthwash
Intervention Description
Will be comparing the impact of using oxygenated mouthwash with other groups.
Intervention Type
Other
Intervention Name(s)
Oxygenated mouth foam
Intervention Description
will be comparing the impact of using oxygenated foam to other groups.
Primary Outcome Measure Information:
Title
Gingival index
Description
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.
Time Frame
baseline
Title
Gingival index
Description
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.
Time Frame
+1 week from baseline
Title
Gingival index
Description
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.
Time Frame
+2 weeks from baseline
Title
Gingival index
Description
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.
Time Frame
+4 weeks from baseline
Title
Gingival index
Description
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.
Time Frame
+8 weeks from baseline
Title
Gingival index
Description
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.
Time Frame
+12 weeks from baseline
Title
Plaque index
Description
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation.
Time Frame
baseline
Title
Plaque index
Description
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
Time Frame
+1 week from baseline
Title
Plaque index
Description
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
Time Frame
+2 weeks from baseline
Title
Plaque index
Description
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
Time Frame
+4 weeks from baseline
Title
Plaque index
Description
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
Time Frame
+8 weeks from baseline
Title
Plaque index
Description
Oral hygiene may be assessed via a plaque index also plaque is a predisposing factor for gingival inflammation
Time Frame
+12 weeks from baseline
Secondary Outcome Measure Information:
Title
Gum Health Experience Questionnaire (GHEQ)
Description
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)
Time Frame
Baseline
Title
Gum Health Experience Questionnaire (GHEQ)
Description
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)
Time Frame
+12 weeks from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haya M Alayadi, PhD
Organizational Affiliation
King Saud University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haya Mahmmod Alayadi
City
Riyadh
ZIP/Postal Code
4312
Country
Saudi Arabia

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
12375458
Citation
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.
Results Reference
background
PubMed Identifier
3522646
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.
Results Reference
background
PubMed Identifier
3013947
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.
Results Reference
background
PubMed Identifier
37735867
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.
Results Reference
background
PubMed Identifier
36401324
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.
Results Reference
background

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Effect of Oxygenated Mouthwash and Mouth Foam

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