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Periodontitis is a biofilm depended oral infection. It leads to inflammatory destruction of periodontal tissues and if left untreated to tooth loss. Porphyromonas gingivalis (P.g.) is one of the major pathogens associated with the onset and progression of periodontitis. Previous in vitro studies have shown that a proanthocyanidin-enriched extract from Rumex acetosa L. inhibits the adhesion of P.g. and acts in a cytoprotective manner. Since the the bacterial adhesion to oral mucosa cells is a pivotal step for the P.g. mediated tissue destruction, its inhibition may be helpful in preventing the colonization with P.g. or its eradication in P.g. infected patients. Therefore, the aim of this controlled, randomized and double blinded study was to analyze the effects of a Proanthocyanidin-enriched extract from Rumex acetosa L. on the intraoral colonization with Porphyromonas gingivalis in individuals harboring P.g. intramurally.
During screening phase plaque samples of healthy individuals were tested via polymerase chain reaction for the prevalence of P.g..
At baseline those identified P.g. positive participants received a supragingival debridement (professional tooth cleaning) and were randomly assigned to the test- or control-group. Afterwards the study participants are instructed to rinse 3 times per day with 10 ml of either Rumex acetosa L. extract mouth rinse or the placebo mouth rinse for 7 days in addition to their oral hygiene procedures. Plaque samples were taken at different visits (screening, baseline, 2, 4, 7 and 14 days after baseline) and P.g. was identified and quantified by real-time polymerase chain reaction (qrt-PCR). Also the relative quantity of eight other oral pathogenic microorganisms (Aggregatibacter actinomycetemcomitans, Treponema denticola, Tannerella forsythia, Prevotella nigrescens, Prevotella intermedia, Eikenella corrodens, Streptococcus mutans and Candida albicans) and four commensal bacteria (Streptococcus sanguinis, Streptococcus mitis, Veillonella parvula and Actinomyces viscosus) was determined over the whole study period by qrt-PCR. Additionally clinical parameters, i.e. the Approximal Plaque Index (API) and the modified Sulcular Bleeding Index (SBI) were recorded at baseline, 7 and 14 days. For identifying any dysplastic changes and mutations as a potential reaction to the tested mouthwash solutions brushing biopsies of the oral mucosa were taken at baseline and day 7 and were histologically examined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rumex acetosa L. extract | Active Comparator | Rumex acetosa L. extract mouthrinse, 10 ml, tid, 3 min, 7 days |
|
| Placebo | Placebo Comparator | Placebo mouthrinse, 10 ml, tid, 3 min, 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rumex acetosa L. extract | Other |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| change of the intraoral prevalence of Porphyromonas gingivalis | change from baseline to 2, 4, 7 and 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| change of the Approximal Plaque Index | change from baseline to 7 and 14 days | |
| change of the Sulcular Bleeding Index | change from baseline to 7 and 14 days | |
| change of the cytopathological appearance of the mucosal tissue |
| Measure | Description | Time Frame |
|---|---|---|
| change of the intraoral prevalence of Aggregatibacter actinomycetemcomitans | change from baseline to 2, 4,7, and 14 days | |
| change of the intraoral prevalence of Treponema denticola | change from baseline to 2, 4, 7, and 14 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Beikler, Prof. | Heinrich-Heine-University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department od Operative Dentistry, Periodontics and Endodontics | Düsseldorf | 40225 | Germany |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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|
| change from baseline to 7 days |
| change of the intraoral prevalence of Tannerella forsythia | change from baseline to 2, 4, 7 and 14 days |
| change of the intraoral prevalence of Prevotella intermedia | change from baseline to 2, 4, 7 and 14 days |
| change of the intraoral prevalence of Prevotella nigrescens | change from baseline to 2, 4, 7 and 14 days |
| change of the intraoral prevalence of Eikenella corrodens | change from baseline to 2, 4, 7 and 14 days |
| change of the intraoral prevalence of Streptococcus mutans | change from baseline to 2, 4, 7 and 14 days |
| change of the intraoral prevalence of Candida albicans | change from baseline to 2, 4, 7 and 14 days |
| change of the intraoral prevalence of Streptococcus sanguinis | change from baseline to 2, 4, 7 and 14 days |
| change of the intraoral prevalence of Streptococcus mitis | change from baseline to 2, 4, 7 and 14 days |
| change of the intraoral prevalence of Veillonella parvula | change from baseline to 2, 4, 7 and 14 days |
| change of the intraoral prevalence of Actinomyces viscosus | change from baseline to 2, 4, 7 and 14 days |