Dental Plaque, Gingivitis
Conditions
Brief summary
The aim of this 4-week clinical study is to evaluate the ability of an experimental toothpaste, containing 0.454 percent (%) Stannous Fluoride (SnF2), 0.3% Zinc Chloride (ZnCl2) and 1% Alumina, to improve gingival health and plaque accumulation compared to a regular fluoride toothpaste (negative control) in participants with plaque-induced mild to moderate gingivitis.
Detailed description
This will be a single-center, 4 weeks, randomized, controlled, examiner-blind, 2 treatment arms, stratified, parallel group design clinical study, investigating gingival health and supra-gingival plaque reduction on healthy participants after using an experimental toothpaste containing 0.454% SnF2, 0.3% ZnCl2 and 1% Alumina. Sufficient participants will be screened so that at least 160 participants are randomized (approximately 80 per group) to ensure approximately 144 (approximately 72 per group) evaluable participants complete the entire study.
Interventions
DRUGTest toothpaste
0.454% Stannous Fluoride, 0.3% Zinc Chloride,1% Alumina toothpaste containing 1100 parts per million (ppm) fluoride.
Commercial toothpaste containing 1450 ppm fluoride.
Sponsors
HALEON
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Provision of a signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study before any assessment is performed. * Biological sex at birth was male or female. * Aged 18 to 70 years inclusive, at the signing of the informed consent. * Willing and able to comply with scheduled visits, treatment plan, saliva sample collection, study restrictions, Lifestyle Considerations and other study procedures. * In good general and mental health with, in the opinion of the investigator or medically qualified designee, no clinically significant or relevant abnormalities in medical history or upon oral examination, or condition, that would impact the participant's safety, wellbeing or the outcome of the study, if they were to participate in the study, or affect the individual's ability to understand and follow study procedures and requirements. * Participant oral health that meets all the following: At Screening (Visit 1): * Participant with at least 20 natural, permanent teeth, (excluding 3rd molars). * Participant with at least 40 evaluable surfaces for MGI, BI, and TPI. * A healthy participant with mild to moderate plaque-induced gingivitis in the opinion of the clinical examiner. * Overall MGI less than or equal to (\<=) 1.75 to \<= 2.30 At Baseline (Visit 2): * Overall MGI greater than or equal to (\>=) 1.75 to \<= 2.30 * Overall TPI score \>= 1.5
Exclusion criteria
* An employee of the investigational site, either directly involved in the conduct of the study or a member of their immediate family; or an employee of the investigational site otherwise supervised by the investigator; or a Haleon employee directly involved in the conduct of the study or a member of their immediate family. * A participant who has participated in other studies (including non-medicinal studies) involving investigational product(s) within 30 days prior to study entry and/or during study participation. * A participant with, in the opinion of the investigator (or medically qualified designee), an acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator or medically qualified designee, would make the participant inappropriate for entry into this study. * A participant who has any other clinical serious or unstable conditions (for example, cardiovascular diseases, diabetes, liver disorders, and kidney disorders) which could have affected study outcomes and/or participant safety. * A participant who is pregnant (self-reported) or intending to become pregnant over the duration of the study. * A participant who is breastfeeding. * A participant with known or suspected intolerance or hypersensitivity to any study materials (or closely related compounds) or any of their stated ingredients. * A participant unwilling or unable to comply with the Lifestyle Considerations described in this protocol. * A participant who is a current smoker or an ex-smoker (including vaper) who stopped within 6 months of Screening. * A participant who is using smokeless forms of tobacco (for example, chewing tobacco, gutkha, pan containing tobacco, nicotine-based e-cigarettes). * A participant who is diagnosed xerostomia or is taking any medication that in the view of the investigator is causing xerostomia. * A participant who has a medical condition which could have directly influenced gingival bleeding. * A participant who has a bleeding disorder that could have affected study outcomes and/or participant safety. * A participant who has a recent history (within the last year) of alcohol or other substance abuse. * A participant who has a severe oral condition (for example, acute necrotizing ulcerative gingivitis or oral or peri-oral ulceration including herpetic lesions) that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant/examiner if they participate in the study. * Presence of a tongue or lip piercing, or any other oral feature that could interfere with the usage of a toothbrush. * Medications exclusions: At Screening (Visit 1): 1. A participant using any antibiotic medication within 28 days prior to screening or at any time during the study. 2. Participant who has used an anti-bacterial toothpaste/mouthwash (for example, chlorhexidine) or another oral care product within 2 weeks of Screening that, in the opinion of the investigator or dentally qualified designee, could affect gingival health, plaque formation or oral bacteria. 3. A participant currently taking an anti-inflammatory medication which, in the opinion of the Investigator, could affect gingival condition. 4. A participant currently taking a systemic medication (for example, anti-inflammatory, anticoagulant, immunosuppressants) or traditional/ herbal remedy which, in the opinion of the Investigator, could affect plaque/ gingival condition (for example, ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers, statins). * Medications exclusions: At Baseline (Visit 2): 1. A participant who has taken any antibiotics during the washout period (between Screening and Baseline). 2. A participant who has taken (in the previous 14 days) a systemic medication (for example, anti-inflammatory, anti-coagulant, immunosuppressants) or traditional/ herbal remedy which, in the opinion of the Investigator, could affect plaque/ gingival condition (for example, ibuprofen, aspirin, warfarin, cyclosporin, phenytoin, calcium channel blockers). 3. A participant who has used an antibacterial dentifrice or mouthwash (for example, chlorhexidine) or any oral care product that in the view of the investigator could interfere with gingival health, plaque formation and oral bacteria, in the period between Screening and the Baseline visit. * Periodontal exclusions: 1. A participant who shows signs of periodontitis \[at both Screening (Visit 1) and Baseline visits (Visit 2)\]. 2. A participant with a Basic Periodontal Examination (BPE) score of 4 or above in one or more sextants. 3. A participant with BPE score \>= 3, if with probing pocket, a single tooth dept is \>= 5 mm. 4. A participant who is receiving or has received treatment for periodontal disease (including surgery) within 12 months of Screening. 5. A participant who has gingivitis, which in the opinion of the investigator, is not expected to respond to treatment with an over the counter (OTC) dentifrice. * Dental Exclusions: 1. A participant who has active caries that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant if they participate in the study. 2. A participant who has dentures (partial or full). 3. A participant who has an orthodontic appliance (bands, appliances, or fixed/ removable retainers). 4. A participant who received orthodontic therapy within 3 months of Screening. 5. A participant who has numerous restorations in a poor state of repair. 6. A participant who has any dental condition (for example, overcrowding) that could, in the opinion of the investigator, compromise study outcomes or the oral health of the participant if they participate in the study. 7. A participant who has had dental prophylaxis within 12 weeks of Screening. 8. A participant who has had teeth bleaching within 12 weeks of Screening. 9. A participant who has high levels of extrinsic stain or calculus deposits, in the opinion of the investigator, that could have interfered with plaque assessments. * A participant who has previously been enrolled in this study. * A participant who, in the opinion of the investigator or medically qualified designee, should not participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Mean Bleeding Index (BI) at Week 4 | Week 4 | The BI is an invasive assessment of gingival bleeding performed using a round-end probe. Presence/absence of gingival bleeding was assessed for 30 seconds after probing. BI was assessed on 3-points scale ranging from 0 to 2, where 0= Absence of bleeding on probing, 1= Bleeding observed within 30 seconds of probing, 2= Bleeding observed immediately on probing. Mean BI was calculated by taking the average over all tooth sites assessed for a participant. Lower score indicated improvement in the symptoms. Adjusted mean value was derived using ANCOVA model. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adjusted Mean Number of Bleeding Sites (NBS) at Week 4 | Week 4 | The bleeding assessment was done using round-end probe. The number of bleeding sites for each participant= the number of evaluable tooth sites with bleeding observed immediately on probing or within 30 seconds of probing. Adjusted mean value was derived using ANCOVA model. |
| Adjusted Mean Modified Gingival Index (MGI) at Week 4 | Week 4 | The MGI is a non-invasive visual assessment of gingival inflammation. MGI was assessed for all evaluable surfaces, four sites per tooth and was scored on a 5-point scale ranging from 0 to 4, where 0= Absence of inflammation, 4= Severe inflammation. Lower score indicated improvement in the symptoms. Adjusted mean value was derived using ANCOVA model. |
| Adjusted Mean Overall Turesky Plaque Index (TPI) at Week 4 | Week 4 | The TPI is a non-invasive assessment of supra-gingival plaque accumulation. The plaque was disclosed using a plaque disclosing dye solution and the TPI was assessed using a 6-point scale ranging from 0 to 5, where 0= No plaque, 5= Plaque covering 2/3 or more of the crown of the tooth. Lower score indicated improvement in the symptoms. Adjusted mean value was derived using ANCOVA model. |
| Adjusted Mean Interproximal TPI at Week 4 | Week 4 | The TPI is a non-invasive assessment of supra-gingival plaque accumulation. The plaque was disclosed using a plaque disclosing dye solution and the TPI was assessed using a 6-point scale ranging from 0 to 5, where 0= No plaque, 5= Plaque covering 2/3 or more of the crown of the tooth. Lower score indicated improvement in the symptoms. Adjusted mean value was derived using ANCOVA model. |
Countries
United Kingdom
Participant flow
Recruitment details
This study was conducted at a single center in United Kingdom.
Pre-assignment details
A total 175 participants were enrolled; 161 participants were randomized to a treatment (80 participants in the test product group and 81 participants in the reference product group). Total 154 participants completed the study (76 participants in the test product group and 78 participants in the reference product group).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 27.0 years STANDARD_DEVIATION 11.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 83 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized African American/African Heritage | 8 Participants |
| Race/Ethnicity, Customized Asian - Central/South Asian Heritage | 26 Participants |
| Race/Ethnicity, Customized Asian - East Asian Heritage | 10 Participants |
| Race/Ethnicity, Customized Asian - South East Asian Heritage | 12 Participants |
| Race/Ethnicity, Customized Multiple | 9 Participants |
| Race/Ethnicity, Customized White - Arabic/North African Heritage | 7 Participants |
| Race/Ethnicity, Customized White - White/Caucasian/European Heritage | 28 Participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 78 | 0 / 83 |
| other Total, other adverse events | 13 / 78 | 6 / 83 |
| serious Total, serious adverse events | 0 / 78 | 0 / 83 |
Outcome results
None listed