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The aim of this study is to compare subject gingival health after 6 weeks of twice daily use of a non-alcohol or alcohol containing mouthrinse and brushing compared to brushing only.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mouthwash with Alcohol | Active Comparator | rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute. |
|
| Mouthwash without Alcohol | Active Comparator | rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine Digluconate Mouthwash with Alcohol | Drug | 0.2% w/v Chlorhexidine Digluconate, alcohol containing - UK Marketed Mouthwash |
|
| Measure | Description | Time Frame |
|---|---|---|
| Gingival Severity Index (GSI) Based on the Gingival Index (GI) | Measure of gingival severity averaged across whole mouth site; each site scored 0, 1, 2, 3 based on GI and,
| Change from baseline to 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gingival Index | The GI was assessed on the facial and lingual surfaces at six sites on each tooth (facial and lingual - distal papillae, margin and mesial papillae). These assessments were performed on all evaluable teeth using moderate pressure sweeping a blunt ended probe, which was engaged in approximately 1 millimetre (mm) into the gingival crevice. The scores could range from 0-3 (0=Absence of inflammation; 1=Mild Inflammation-Slight change in color slight change in texture, no bleeding on probing; 2=Moderate Inflammation -glazing, redness edema and hypertrophy, bleeding on probing; 3= Severe inflammation-marked redness and hypertrophy, tendency for spontaneous bleeding) |
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Inclusion Criteria:
Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral/ dental examination.
5. a) Good oral health in the opinion of the investigator (allowing mild to moderate gingivitis to meet entry criteria).
b) A minimum of 20 permanent gradable teeth at screening. (Gradable teeth are those where restorative materials cover less than 25% of the tooth surface graded).
c) Mild to moderate gingivitis present at the screening visit in the opinion of the investigator.
d) Positive response to bleeding on brushing exercise at screening visit. e) A total of 20 bleeding sites or greater at baseline visit.
Exclusion Criteria:
Known or suspected intolerance or hypersensitivity to Chlorhexidine or other study materials (or closely related compounds) or any of their stated ingredients.
5. a) Current or relevant history of any serious, severe or unstable physical or psychiatric illness or any other medical condition (e.g. Diabetes Mellitus) that would make the subject unlikely to fully complete the study or any that increases the risk to the subject or undermines the data validity.
b) Subjects requiring prophylactic antibiotic treatment prior to dental therapy.
c) Use of concomitant medication that, in the opinion of the investigator, might interfere with the outcome of the study or increases the risk to the subject (eg: phenytoin, calcium antagonists, cyclosporine, warfarin, antibiotics, immuno-suppressants).
d) Use of antibiotics within two weeks prior to the screening visit or throughout the study.
e) Use of any systemic medication which would have an effect on gingival conditions within 14 days of gingival examinations (eg: ibuprofen or aspirin therapy) 6. a) Have current active caries b) More than 3 pockets with 5mm or over. c) Excessive calculus present that interferes with the probing examination for Gingival Index.
d) Other severe oral/ gingival conditions (e.g. Acute Necrotizing Ulcerative Gingivitis) that may compromise the study or the subjects in the opinion of the investigator or gingivitis examiner.
e) Medical conditions which may directly influence gingival bleeding. f) Restorations in a poor state of repair. g) Orthodontic appliances anterior cosmetic restorations and veneers. h) Enamel pitting/irregularities. 7. Subjects using chewing tobacco, pan, pan-masala, gutkha or other chewing tobacco products or subjects who have quit using any of those within the past six months prior to screening.
8. b) An employee of any toothpaste manufacturer or their immediate family.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intertek 4-Front Research - Widnes | Widnes | Cheshire | WA8 6PG | United Kingdom | ||
| 4Front, Ellesmere Port |
A total of 775 subjects were screened and 324 subjects were randomised of whom 319 completed the study. The high screen failure rate was due mainly to subjects not having sufficient permanently gradable teeth.
Participants were recruited at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mouthwash With Alcohol | Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute. |
| FG001 | Mouthwash Without Alcohol | Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute. |
| FG002 | Reference | Brushing alone with the standard toothpaste for one timed minute twice daily for 6 weeks. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mouthwash With Alcohol | Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute. |
| BG001 | Mouthwash Without Alcohol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Gingival Severity Index (GSI) Based on the Gingival Index (GI) | Measure of gingival severity averaged across whole mouth site; each site scored 0, 1, 2, 3 based on GI and,
| This analysis was conducted on the Intent-to-Treat (ITT) population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement. | Posted | Mean | Standard Error | Units on a scale | Change from baseline to 6 weeks |
|
Adverse Events (AEs) and serious AEs were collected from the start of the washout product at visit 1, and until five days following last administration of the investigational product.
The sum of number of participants affected is more than the total number affected, because multiple occurrances of an event was counted only once in a participant.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mouthwash With Alcohol | Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis left thigh | Infections and infestations | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tongue coated | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D005891 | Gingivitis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D005882 | Gingival Diseases |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Chlorhexidine Digluconate Mouthwash without Alcohol | Drug | 0.2% w/v Chlorhexidine Digluconate, without alcohol - UK Marketed Mouthwash |
|
| Change from baseline to 6 weeks |
| Turesky Modification of Quigley & Hein Plaque Index for Overall Plaque Scores | Overall plaque scores were calculated taking the average over all tooth sites for a participant. The scores could range from 0-5 (0=No plaque; 1=Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3=A band of plaque wider than 1 mm but covering less than 1/3 of the area to be graded of the crown of the tooth; 4=Plaque covering at least 1/3 but less than 2/3 of the area to be graded of the crown of the tooth; 5=Plaque covering 2/3 or more of the area to be graded of the crown of the tooth) | Change from baseline to 6 weeks |
| Turesky Modification of Quigley & Hein Plaque Index for Interproximal Plaque Scores | Interproximal plaque scores were analyzed on the mesiofacial, distofacial, mesiolingual and distolingual surfaces, and calculated taking the average over all tooth sites for a participant. The scores could range from 0-5 (0=No plaque; 1=Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3=A band of plaque wider than 1 mm but covering less than 1/3 of the area to be graded of the crown of the tooth; 4=Plaque covering at least 1/3 but less than 2/3 of the area to be graded of the crown of the tooth; 5=Plaque covering 2/3 or more of the area to be graded of the crown of the tooth) | Change from baseline to 6 weeks |
| Cheshire |
| CH65 4BW |
| United Kingdom |
| Intertek - Manchester Science Park | Manchester | M15 6SE | United Kingdom |
Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute. |
| BG002 | Reference | Brushing alone with the standard toothpaste for 1 timed minute twice daily for 6 weeks. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Mouthwash Without Alcohol |
Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute. |
| OG002 | Reference | Brushing alone with the standard toothpaste for 1 timed minute twice daily for 6 weeks. |
|
|
|
| Secondary | Gingival Index | The GI was assessed on the facial and lingual surfaces at six sites on each tooth (facial and lingual - distal papillae, margin and mesial papillae). These assessments were performed on all evaluable teeth using moderate pressure sweeping a blunt ended probe, which was engaged in approximately 1 millimetre (mm) into the gingival crevice. The scores could range from 0-3 (0=Absence of inflammation; 1=Mild Inflammation-Slight change in color slight change in texture, no bleeding on probing; 2=Moderate Inflammation -glazing, redness edema and hypertrophy, bleeding on probing; 3= Severe inflammation-marked redness and hypertrophy, tendency for spontaneous bleeding) | This analysis was conducted on the Intent-to-Treat (ITT) population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement. | Posted | Mean | Standard Error | Units on a scale | Change from baseline to 6 weeks |
|
|
|
|
| Secondary | Turesky Modification of Quigley & Hein Plaque Index for Overall Plaque Scores | Overall plaque scores were calculated taking the average over all tooth sites for a participant. The scores could range from 0-5 (0=No plaque; 1=Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3=A band of plaque wider than 1 mm but covering less than 1/3 of the area to be graded of the crown of the tooth; 4=Plaque covering at least 1/3 but less than 2/3 of the area to be graded of the crown of the tooth; 5=Plaque covering 2/3 or more of the area to be graded of the crown of the tooth) | This analysis was conducted on the Intent-to-Treat (ITT) population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement. | Posted | Mean | Standard Error | Units on a scale | Change from baseline to 6 weeks |
|
|
|
|
| Secondary | Turesky Modification of Quigley & Hein Plaque Index for Interproximal Plaque Scores | Interproximal plaque scores were analyzed on the mesiofacial, distofacial, mesiolingual and distolingual surfaces, and calculated taking the average over all tooth sites for a participant. The scores could range from 0-5 (0=No plaque; 1=Slight flecks of plaque at the cervical margin of the tooth; 2= A thin continuous band of plaque (1 mm or smaller) at the cervical margin of the tooth; 3=A band of plaque wider than 1 mm but covering less than 1/3 of the area to be graded of the crown of the tooth; 4=Plaque covering at least 1/3 but less than 2/3 of the area to be graded of the crown of the tooth; 5=Plaque covering 2/3 or more of the area to be graded of the crown of the tooth) | This analysis was conducted on ITT population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement. | Posted | Mean | Standard Error | Units on a scale | Change from baseline to 6 weeks |
|
|
|
|
| 0 |
| 108 |
| 67 |
| 108 |
| EG001 | Mouthwash Without Alcohol | Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute. | 1 | 109 | 60 | 109 |
| EG002 | Reference | Brushing alone with the standard toothpaste for one timed minute twice daily for 6 weeks. | 0 | 107 | 47 | 107 |
| Glossodynia | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Ageusia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Mouth ulceration | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA | Systematic Assessment |
|
| Mouth injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Sensitivity of teeth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gingival bleeding | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Oral discomfort | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gingival injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Lip ulceration | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Gingival pain | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Lip injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Oral mucosal exfoliation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Tongue disorder | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Tongue ulceration | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Traumatic ulcer | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Chapped lips | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Enlarged uvula | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gingival Abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Gingival blister | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Gingival inflammation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Tongue dry | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Tongue injury | Infections and infestations | MedDRA | Systematic Assessment |
|
| Tooth abscess | Infections and infestations | MedDRA | Systematic Assessment |
|
| Tooth disorder | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Oropharyngeal pain | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Otorrhoea | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Chills | General disorders | MedDRA | Systematic Assessment |
|
| Colposcopy abnormal | Investigations | MedDRA | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA | Systematic Assessment |
|
| Eczema eyelids | Eye disorders | MedDRA | Systematic Assessment |
|
| Eye inflammation | Eye disorders | MedDRA | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Gastroenteritis norovirus | Infections and infestations | MedDRA | Systematic Assessment |
|
| Herpes virus infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Limb Injury | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Post-traumatic neck syndrome | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Vulvovaginal candidiasis | Infections and infestations | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D009057 |
| Stomatognathic Diseases |
| Null hypothesis stated that there was no difference between the two treatment groups. | ANCOVA | <0.0001 | From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline GI as a covariate. | Adjusted Mean Difference | -0.08 | 2-Sided | 95 | -0.11 | -0.06 | Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment. | No | Superiority or Other |
| Null hypothesis stated that there was no difference between the two treatment groups in Overall Plaque Scores. | ANCOVA | <0.0001 | From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate | Adusted Mean Difference | -0.86 | 2-Sided | 95 | -1.04 | -0.68 | Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment. | No | Superiority or Other |
| Null hypotheses stated that there was no difference between the two groups. | ANCOVA | <0.0001 | From ANCOVA with factors for treatment group, site, smoking status, number of bleeding sites strata and the baseline Plaque as a covariate | Adjusted Mean Difference | -0.97 | 2-Sided | 95 | -1.16 | -0.78 | Difference is first named treatment minus second named treatment such that a negative difference favours the first named treatment. | No | Superiority or Other |