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| Name | Class |
|---|---|
| Göteborg University | OTHER |
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The aim of the present study was to study if there are interactions and reduced clinical effect between chlorhexidine and fluoride when they are combined in the same mouthrinse.
The investigation assessed the clinical effect of a mouthrinse containing chlorhexidine (CHX) and sodium fluoride (NaF) during a 4-day period of non-brushing and a 6-week period of brushing. Two studies were designed as double-blind, randomized, cross-over clinical trials. In study I, 16 healthy subjects rinsed twice daily for 1 min during 4 days of no tooth brushing with four mouthrinse solutions: 1) 0.12% CHX + 0.2% NaF, 2) 0.2% NaF, 3) 0.12% CHX, and 4) placebo. In study 2, 16 healthy subjects rinsed with the same four solutions twice daily after tooth brushing during a 6-week period. Primary outcomes were plaque formation and gingivitis. Secondary outcomes were fluoride retention and microbiological parameters in plaque and saliva (total bacterial counts and mutans streptococci, lactobacilli and streptococci sanguinis counts). One way analyses of variance with post hoc Student-Newman-Keul´s statistical test was performed for comparisons between mouthrinses. Intragroup changes over time were analyzed with a paired t-test.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.12 % chlorhexidine + 0.2 % NaF mouthrinse | Active Comparator | A mouthrinse combining chlorhexidine and NaF |
|
| 0.2 % NaF mouthrinse | Active Comparator | A mouthrinse containing NaF |
|
| 0.12% chlorhexidine mouthrinse | Active Comparator | A mouthrinse containing chlorhexidine |
|
| Placebo mouthrinse | Placebo Comparator | A mouthrinse containing all basic ingredients as the other three mouth rinses compared but without chlorhexidine and fluoride |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.12 % chlorhexidine + 0.2 % NaF mouthrinse | Drug | In study I, subjects were asked to refrain from tooth brushing and interdental cleaning and rinse with 10 ml of the assigned test solution for one minute, twice daily (morning and evening) during 4 days. In study II, subjects were asked to rinse with 10ml of the assigned test solution twice daily after tooth brushing during a 6-week period. |
| Measure | Description | Time Frame |
|---|---|---|
| Plaque index | Baseline | |
| Plaque index | Day 4 | |
| Plaque index | Day 42 | |
| Gingivitis index | Baseline | |
| Gingivitis index | Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Mutans streptococci counts in dental plaque and saliva | Day 0 | |
| Mutans streptococci counts in dental plaque and saliva | Day 4 | |
| Streptococcus sanguis counts in dental plaque and saliva |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Per Ramberg, Professor | Göteborg University | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 4532119 | Background | Axelsson P, Lindhe J. The effect of a preventive programme on dental plaque, gingivitis and caries in schoolchildren. Results after one and two years. J Clin Periodontol. 1974;1(2):126-38. doi: 10.1111/j.1600-051x.1974.tb01248.x. No abstract available. | |
| 3422503 | Background | Barkvoll P, Rolla G, Bellagamba S. Interaction between chlorhexidine digluconate and sodium monofluorophosphate in vitro. Scand J Dent Res. 1988 Feb;96(1):30-3. doi: 10.1111/j.1600-0722.1988.tb01404.x. |
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| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
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| ID | Term |
|---|---|
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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|
| 0.2 % NaF mouthrinse | Drug | In study I, subjects were asked to refrain from tooth brushing and interdental cleaning and rinse with 10 ml of the assigned test solution for one minute, twice daily (morning and evening) during 4 days. In study II, subjects were asked to rinse with 10ml of the assigned test solution twice daily after tooth brushing during a 6-week period. |
|
|
| 0.12% chlorhexidine | Drug | In study I, subjects were asked to refrain from tooth brushing and interdental cleaning and rinse with 10 ml of the assigned test solution for one minute, twice daily (morning and evening) during 4 days. In study II, subjects were asked to rinse with 10ml of the assigned test solution twice daily after tooth brushing during a 6-week period. |
|
|
| Placebo | Other | Contained all basic ingredients as the other three mouthrinses but no chlorhexidine and no NaF. In study I, subjects were asked to refrain from tooth brushing and interdental cleaning and rinse with 10 ml of the assigned test solution for one minute, twice daily (morning and evening) during 4 days. In study II, subjects were asked to rinse with 10ml of the assigned solution twice daily after tooth brushing during a 6-week period. |
|
| Day 42 |
| Lactobacilli counts in dental plaque and saliva | Day 0 |
| Lactobacilli counts in dental plaque and saliva | Day 4 |
| Lactobacilli counts in dental plaque and saliva | Day 42 |
| Streptococcus sanguinis counts in dental plaque and saliva | Day 0 |
| Streptococcus sanguinis counts in dental plaque and saliva | Day 4 |
| Streptococcus sanguinis counts in dental plaque and saliva | Day 42 |
| Total bacterial counts in dental plaque and saliva | Day 0 |
| Total bacterial counts in dental plaque and saliva | Day 4 |
| Total bacterial counts in dental plaque and saliva | Day 42 |
| 266752 | Background | Emilson CG. Susceptibility of various microorganisms to chlorhexidine. Scand J Dent Res. 1977 May;85(4):255-65. doi: 10.1111/j.1600-0722.1977.tb00561.x. |
| 6585909 | Background | Dahlen G. Effect of antimicrobial mouthrinses on salivary microflora in healthy subjects. Scand J Dent Res. 1984 Feb;92(1):38-42. |
| 292158 | Background | Dolles OK, Bonesvoll P, Gamst ON, Gjermo P. Determination of fluoride and chlorhexidine from chlorhexidine/fluoride-containing dentifrices. Scand J Dent Res. 1979 Apr;87(2):115-22. doi: 10.1111/j.1600-0722.1979.tb00662.x. |