A Phase 4 interventional study of Chlorhexidine Digluconate Mouthwash with Alcohol and Chlorhexidine Digluconate Mouthwash without Alcohol in Gingivitis, sponsored by GlaxoSmithKline. Completed at 3 sites in United Kingdom. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-07-28.
Sponsored by GlaxoSmithKline · Phase 4, Interventional, and Treatment
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.
609 studies on the registry are indexed under Gingivitis; 107 are open to participants now.
This study's enrollment of 324 is above the median of 63 across 494 interventional studies indexed under Gingivitis.
Browse Gingivitis studies →GlaxoSmithKline is the lead sponsor of 3,647 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 239 (91%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
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.
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.
Drug: Chlorhexidine Digluconate Mouthwash with 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.
Drug: Chlorhexidine Digluconate Mouthwash without Alcohol
Drug pages: Chlorhexidine gluconate · Ethanol
0.2% w/v Chlorhexidine Digluconate, alcohol containing - UK Marketed Mouthwash
0.2% w/v Chlorhexidine Digluconate, without alcohol - UK Marketed Mouthwash
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
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
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
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
Participants were recruited at the clinical site.
| Milestone | Mouthwash With Alcohol | Mouthwash Without Alcohol | Reference |
|---|---|---|---|
| Started | 108 | 109 | 107 |
| Completed | 105 | 109 | 105 |
| Not completed | 3 | 0 | 2 |
| Withdrew: Adverse event | 2 | 0 | 0 |
| Withdrew: Other reason (unknown) | 1 | 0 | 2 |
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)
| Units on a scale | Mouthwash With Alcohol | Mouthwash Without Alcohol | Reference |
|---|---|---|---|
| Gingival Severity Index (GSI) Based on the Gingival Index (GI) | 0.152 ± 0.0085 | 0.143 ± 0.0072 | 0.212 ± 0.0121 |
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)
| Units on a scale | Mouthwash With Alcohol | Mouthwash Without Alcohol | Reference |
|---|---|---|---|
| Gingival Index | 1.12 ± 0.012 | 1.11 ± 0.010 | 1.19 ± 0.014 |
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)
| Units on a scale | Mouthwash With Alcohol | Mouthwash Without Alcohol | Reference |
|---|---|---|---|
| Turesky Modification of Quigley & Hein Plaque Index for Overall Plaque Scores | 2.50 ± 0.082 | 2.40 ± 0.084 | 3.34 ± 0.062 |
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)
| Units on a scale | Mouthwash With Alcohol | Mouthwash Without Alcohol | Reference |
|---|---|---|---|
| Turesky Modification of Quigley & Hein Plaque Index for Interproximal Plaque Scores | 2.77 ± 0.090 | 2.63 ± 0.091 | 3.69 ± 0.065 |
Collected over 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.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mouthwash With Alcohol | — | 0/108 (0%) | 67/108 (62%) |
| Mouthwash Without Alcohol | — | 1/109 (0.9%) | 60/109 (55%) |
| Reference | — | 0/107 (0%) | 47/107 (43.9%) |
| Event | Mouthwash With Alcohol | Mouthwash Without Alcohol | Reference |
|---|---|---|---|
| Cellulitis left thighInfections and infestations | 0/108 | 1/109 | 0/107 |
| Event | Mouthwash With Alcohol | Mouthwash Without Alcohol | Reference |
|---|---|---|---|
| HeadacheNervous system disorders | 19/108 | 14/109 | 13/107 |
| Tongue coatedGastrointestinal disorders | 13/108 | 8/109 | 2/107 |
| Upper respiratory tract infectionInfections and infestations | 11/108 | 9/109 | 9/107 |
| GlossodyniaGastrointestinal disorders | 5/108 | 9/109 | 0/107 |
| DysgeusiaNervous system disorders | 6/108 | 1/109 | 0/107 |
| Paraesthesia oralGastrointestinal disorders | 5/108 | 6/109 | 0/107 |
| AgeusiaNervous system disorders | 3/108 | 6/109 | 0/107 |
| Oral herpesInfections and infestations | 1/108 | 2/109 | 5/107 |
| Dry mouthGastrointestinal disorders | 4/108 | 5/109 | 0/107 |
| Hypoaesthesia oralGastrointestinal disorders | 2/108 | 5/109 | 0/107 |
| Age, Continuous(Years) | Mouthwash With Alcohol | Mouthwash Without Alcohol | Reference | Total |
|---|---|---|---|---|
| Mean | 37.8 ± 10.89 | 36.2 ± 11.31 | 36.5 ± 10.48 | 36.8 ± 10.89 |
| Sex: Female, Male(Participants) | Mouthwash With Alcohol | Mouthwash Without Alcohol | Reference | Total |
|---|---|---|---|---|
| Female | 85 | 79 | 75 | 239 |
| Male | 23 | 30 | 32 | 85 |
The record gives a start of Oct 2012, a primary completion of Mar 2013 and a completion of Mar 2013. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2014, 1 year 4 months after primary completion.
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Studies of the drugs tested here: Chlorhexidine gluconate · Ethanol