Gingivitis
Conditions
Keywords
Gingivitis, plaque, interproximal cleaning, dental floss
Brief summary
The purpose of this study is to evaluate the safety and efficacy of tooth and interproximal cleaning modalities with and without chemistry on oral health over 28 days.
Interventions
DEVICEAirFloss + BreathRx
Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.
DEVICEAirFloss + Listerine
Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.
DEVICEDental Floss
Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning used once daily.
DEVICEManual Toothbrush
Manual Toothbrush used twice daily, 1 minute.
Sponsors
Philips Oral Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Be willing and physically able to carry out all study procedures and be available at all times required for participation * Be able to fully understand and comply with the written and verbal instructions provided * Provide written Informed Consent * Be age 18 - 65 years * Agree to return study materials at the required visits * Be a non-smoker * Have a minimum of 20 'scorable' teeth (excluding 3rd molars) * Have a minimum average plaque score of \> 0.5 per RMNPI scoring with 2-6 hours of plaque accumulation * Have a Gingival Bleeding Index of -\>1 on at least 10 sites * Be a regular manual toothbrush user * Be a non or irregular flosser defined as using dental floss or any other interproximal cleaning technique once per week or less often
Exclusion criteria
* A medical or dental condition that would be unduly affected by participation in this study, per Investigator discretion * Pregnant or nursing per subject report * A medical condition requiring antibiotic pre-medication prior to dental appointments * Diagnosis of xerostomia * Any oral or extra oral piercing that interferes with the ability to perform study procedures and/or clinical assessments in the mouth * Currently undergoing or requiring dental/periodontal treatment, or having had periodontal treatment in the six months preceding the study, where the subject's study participation could present an undue safety risk or obscure the evaluation of study endpoints, per Investigator /Examiner discretion * Oral surgery within the last 2 months * Current use of professionally dispensed bleaching products * A known allergy or sensitivity to products planned for use in this study * Unwillingness to abstain from all other oral hygiene products other than those prescribed for the duration of the study * Unwillingness to abstain from all other oral hygiene products other than those prescribed for the duration of the study * Participation in an oral care study within the previous 90 days * Be an employee or a relative of an employee of the Site clinical research department, dental school, or a dental products manufacturing, research or marketing firm * Are a dental student or dental professional * A cardiac pacemaker or implanted cardiac defibrillator * Insulin-Dependent Diabetes * Current use of antibiotic medications or use within 4 weeks of enrollment * Current use of prescription-dose anti-inflammatory medications or anticoagulants; (including aspirin \> 81 mg daily) * Presence of advanced periodontal disease or excessive gingival recession, per Investigator/Examiner discretion * Heavy deposits of calculus, either supragingival and/or subgingival, per Investigator/Examiner discretion * Extensive crown or bridge work and/or rampant decay, per Investigator/Examiner discretion * Presence of orthodontic bands interfering with efficacy outcome(s) per Investigator/Examiner discretion * Have a professional prophylaxis within 4 weeks of the study * Be a regular power toothbrush user
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14 | 14 days | MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28 | 28 days | MGI is a validated assessment of Gingival inflammation using a 4 point scale from 0 (absence of inflammation) to 4 (severe inflammation). |
| Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14 | 14 days | GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding). |
| Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28 | 28 days | GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding). |
| Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14 | 14 days | RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence). |
| Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28 | 28 days | RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| AirFloss + Rinse1 AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute. | 79 |
| AirFloss + Rinse2 AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute. | 78 |
| String Floss String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute | 79 |
| Manual Toothbrush Manual Toothbrush is used twice a day for 1 minute | 51 |
| Total | 287 |
Baseline characteristics
| Characteristic | AirFloss + Rinse1 | AirFloss + Rinse2 | String Floss | Manual Toothbrush | Total |
|---|---|---|---|---|---|
| Age, Continuous | 37 years STANDARD_DEVIATION 12.2 | 35.6 years STANDARD_DEVIATION 10.7 | 34.9 years STANDARD_DEVIATION 11 | 35.1 years STANDARD_DEVIATION 12.1 | 35.7 years STANDARD_DEVIATION 11.5 |
| Region of Enrollment United States | 79 participants | 78 participants | 79 participants | 51 participants | 287 participants |
| Sex: Female, Male Female | 50 Participants | 50 Participants | 51 Participants | 33 Participants | 184 Participants |
| Sex: Female, Male Male | 29 Participants | 28 Participants | 28 Participants | 18 Participants | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 79 | 1 / 78 | 1 / 78 | 0 / 51 |
| serious Total, serious adverse events | 0 / 79 | 0 / 78 | 0 / 78 | 0 / 51 |
Outcome results
Primary
Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14
MGI is a validated assessment of Gingival inflammation using a 4 point range where 0 (absence of inflammation) to 4 (severe inflammation).
Time frame: 14 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AirFloss + Rinse1 | Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14 | 0.10 units on a scale | Standard Error 0.01 |
| AirFloss + Rinse2 | Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14 | 0.10 units on a scale | Standard Error 0.01 |
| String Floss | Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14 | 0.10 units on a scale | Standard Error 0.01 |
| Manual Toothbrush | Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 14 | 0.01 units on a scale | Standard Error 0.01 |
Secondary
Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14
GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).
Time frame: 14 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AirFloss + Rinse1 | Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14 | 0.05 units on a scale | Standard Error 0 |
| AirFloss + Rinse2 | Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14 | 0.05 units on a scale | Standard Error 0 |
| String Floss | Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14 | 0.05 units on a scale | Standard Error 0 |
| Manual Toothbrush | Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 14 | 0.00 units on a scale | Standard Error 0.01 |
Secondary
Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28
GBI is a validated assessment of gingival bleeding using a 4 point scale with 0 (no bleeding) to 3 (spontaneous bleeding).
Time frame: 28 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AirFloss + Rinse1 | Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28 | 0.08 units on a scale | Standard Error 0 |
| AirFloss + Rinse2 | Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28 | 0.08 units on a scale | Standard Error 0 |
| String Floss | Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28 | 0.09 units on a scale | Standard Error 0 |
| Manual Toothbrush | Change From Baseline in Gingival Bleeding Index (GBI) on a 4 Point Scale at Day 28 | 0.01 units on a scale | Standard Error 0.01 |
Secondary
Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28
MGI is a validated assessment of Gingival inflammation using a 4 point scale from 0 (absence of inflammation) to 4 (severe inflammation).
Time frame: 28 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AirFloss + Rinse1 | Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28 | 0.20 units on a scale | Standard Error 0.01 |
| AirFloss + Rinse2 | Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28 | 0.22 units on a scale | Standard Error 0.01 |
| String Floss | Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28 | 0.26 units on a scale | Standard Error 0.01 |
| Manual Toothbrush | Change From Baseline in Gingival Inflammation on a 4 Point Scale Using the Modified Gingival Index (MGI) at Day 28 | 0.03 units on a scale | Standard Error 0.02 |
Secondary
Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28
RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
Time frame: 28 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AirFloss + Rinse1 | Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28 | 0.15 units on a scale | Standard Error 0.01 |
| AirFloss + Rinse2 | Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28 | 0.16 units on a scale | Standard Error 0.01 |
| String Floss | Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28 | 0.17 units on a scale | Standard Error 0.01 |
| Manual Toothbrush | Change From Baseline in Rustogi Modification of Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 28 | 0.04 units on a scale | Standard Error 0.01 |
Secondary
Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14
RMNPI is a validated assessment of visual surface dental plaque using a dichotomous scale 0 (absence) to 1 (presence).
Time frame: 14 days
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| AirFloss + Rinse1 | Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14 | 0.09 units on a scale | Standard Error 0.01 |
| AirFloss + Rinse2 | Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14 | 0.10 units on a scale | Standard Error 0.01 |
| String Floss | Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14 | 0.11 units on a scale | Standard Error 0.01 |
| Manual Toothbrush | Change From Baseline Using Rustogi Modification of the Navy Plaque Index (RMNPI) Using a Dichotomous Scale at Day 14 | 0.04 units on a scale | Standard Error 0.01 |