Gingivitis
Conditions
Brief summary
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.
Interventions
DRUGChlorhexidine Digluconate Mouthwash with Alcohol
0.2% w/v Chlorhexidine Digluconate, alcohol containing - UK Marketed Mouthwash
0.2% w/v Chlorhexidine Digluconate, without alcohol - UK Marketed Mouthwash
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Gingival Severity Index (GSI) Based on the Gingival Index (GI) | Change from baseline to 6 weeks | Measure of gingival severity averaged across whole mouth site; each site scored 0, 1, 2, 3 based on GI and, 1. GSI = 0 if GI is 0 or 1 (no bleeding) 2. GSI = 1 if GI is 1 or 2 (bleeding) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gingival Index | Change from baseline to 6 weeks | 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) |
| Turesky Modification of Quigley & Hein Plaque Index for Overall Plaque Scores | Change from baseline to 6 weeks | 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) |
| Turesky Modification of Quigley & Hein Plaque Index for Interproximal Plaque Scores | Change from baseline to 6 weeks | 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) |
Countries
United Kingdom
Participant flow
Recruitment details
Participants were recruited at the clinical site.
Pre-assignment details
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 by arm
| Arm | Count |
|---|---|
| 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. | 108 |
| 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. | 109 |
| Reference Brushing alone with the standard toothpaste for 1 timed minute twice daily for 6 weeks. | 107 |
| Total | 324 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 | 0 |
| Overall Study | Other Reason (unknown) | 1 | 0 | 2 |
Baseline characteristics
| Characteristic | Mouthwash With Alcohol | Mouthwash Without Alcohol | Reference | Total |
|---|---|---|---|---|
| Age, Continuous | 37.8 Years STANDARD_DEVIATION 10.89 | 36.2 Years STANDARD_DEVIATION 11.31 | 36.5 Years STANDARD_DEVIATION 10.48 | 36.8 Years STANDARD_DEVIATION 10.89 |
| Sex: Female, Male Female | 85 Participants | 79 Participants | 75 Participants | 239 Participants |
| Sex: Female, Male Male | 23 Participants | 30 Participants | 32 Participants | 85 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 67 / 108 | 60 / 109 | 47 / 107 |
| serious Total, serious adverse events | 0 / 108 | 1 / 109 | 0 / 107 |
Outcome results
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, 1. GSI = 0 if GI is 0 or 1 (no bleeding) 2. GSI = 1 if GI is 1 or 2 (bleeding)
Time frame: Change from baseline to 6 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mouthwash With Alcohol | Gingival Severity Index (GSI) Based on the Gingival Index (GI) | 0.152 Units on a scale | Standard Error 0.0085 |
| Mouthwash Without Alcohol | Gingival Severity Index (GSI) Based on the Gingival Index (GI) | 0.143 Units on a scale | Standard Error 0.0072 |
| Reference | Gingival Severity Index (GSI) Based on the Gingival Index (GI) | 0.212 Units on a scale | Standard Error 0.0121 |
Comparison: Null hypothesis stated that there was no difference between the two groups.p-value: <0.000195% CI: [-0.081, -0.041]ANCOVA
Comparison: Null hypothesis stated that there was no difference between the two treatment groups.p-value: <0.000195% CI: [-0.09, -0.05]ANCOVA
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)
Time frame: Change from baseline to 6 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mouthwash With Alcohol | Gingival Index | 1.12 Units on a scale | Standard Error 0.012 |
| Mouthwash Without Alcohol | Gingival Index | 1.11 Units on a scale | Standard Error 0.01 |
| Reference | Gingival Index | 1.19 Units on a scale | Standard Error 0.014 |
Comparison: Null hypothesis that there was no difference between the two treatment groups.p-value: <0.000195% CI: [-0.1, -0.05]ANCOVA
Comparison: Null hypothesis stated that there was no difference between the two treatment groups.p-value: <0.000195% CI: [-0.11, -0.06]ANCOVA
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)
Time frame: Change from baseline to 6 weeks
Population: This analysis was conducted on ITT population, defined as those subjects who received study treatment and had at least one post-baseline efficacy measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mouthwash With Alcohol | Turesky Modification of Quigley & Hein Plaque Index for Interproximal Plaque Scores | 2.77 Units on a scale | Standard Error 0.09 |
| Mouthwash Without Alcohol | Turesky Modification of Quigley & Hein Plaque Index for Interproximal Plaque Scores | 2.63 Units on a scale | Standard Error 0.091 |
| Reference | Turesky Modification of Quigley & Hein Plaque Index for Interproximal Plaque Scores | 3.69 Units on a scale | Standard Error 0.065 |
Comparison: Null hypotheses stated that there was no difference between the two treatments.p-value: <0.000195% CI: [-1.07, -0.69]ANCOVA
Comparison: Null hypotheses stated that there was no difference between the two groups.p-value: <0.000195% CI: [-1.16, -0.78]ANCOVA
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)
Time frame: Change from baseline to 6 weeks
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mouthwash With Alcohol | Turesky Modification of Quigley & Hein Plaque Index for Overall Plaque Scores | 2.50 Units on a scale | Standard Error 0.082 |
| Mouthwash Without Alcohol | Turesky Modification of Quigley & Hein Plaque Index for Overall Plaque Scores | 2.40 Units on a scale | Standard Error 0.084 |
| Reference | Turesky Modification of Quigley & Hein Plaque Index for Overall Plaque Scores | 3.34 Units on a scale | Standard Error 0.062 |
Comparison: Null hypothesis stated that there was no difference between the two treatment groups in Overall Plaque Scores.p-value: <0.000195% CI: [-1.04, -0.68]ANCOVA
Comparison: Null hypothesis stated that there was no difference between the two treatment groups in Overall Plaque scores.p-value: <0.000195% CI: [-0.98, -0.62]ANCOVA