An Early Phase 1 interventional study of Rumex acetosa L. extract and Placebo in Periodontitis, sponsored by Heinrich-Heine University, Duesseldorf. Completed at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-17.
Sponsored by Heinrich-Heine University, Duesseldorf · Early Phase 1, Interventional, and Prevention
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 35 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →Heinrich-Heine University, Duesseldorf is the lead sponsor of 174 studies on the registry; 52 are open to participants now.
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Exclusion Criteria:
Rumex acetosa L. extract mouthrinse, 10 ml, tid, 3 min, 7 days
Other: Rumex acetosa L. extract
Placebo mouthrinse, 10 ml, tid, 3 min, 7 days
Other: Placebo
change of the intraoral prevalence of Porphyromonas gingivalis
Time frame: change from baseline to 2, 4, 7 and 14 days
change of the Approximal Plaque Index
Time frame: change from baseline to 7 and 14 days
change of the Sulcular Bleeding Index
Time frame: change from baseline to 7 and 14 days
change of the cytopathological appearance of the mucosal tissue
Time frame: change from baseline to 7 days
change of the intraoral prevalence of Aggregatibacter actinomycetemcomitans
Time frame: change from baseline to 2, 4,7, and 14 days
change of the intraoral prevalence of Treponema denticola
Time frame: change from baseline to 2, 4, 7, and 14 days
change of the intraoral prevalence of Tannerella forsythia
Time frame: change from baseline to 2, 4, 7 and 14 days
change of the intraoral prevalence of Prevotella intermedia
Time frame: change from baseline to 2, 4, 7 and 14 days
change of the intraoral prevalence of Prevotella nigrescens
Time frame: change from baseline to 2, 4, 7 and 14 days
change of the intraoral prevalence of Eikenella corrodens
Time frame: change from baseline to 2, 4, 7 and 14 days
change of the intraoral prevalence of Streptococcus mutans
Time frame: change from baseline to 2, 4, 7 and 14 days
change of the intraoral prevalence of Candida albicans
Time frame: change from baseline to 2, 4, 7 and 14 days
change of the intraoral prevalence of Streptococcus sanguinis
Time frame: change from baseline to 2, 4, 7 and 14 days
change of the intraoral prevalence of Streptococcus mitis
Time frame: change from baseline to 2, 4, 7 and 14 days
change of the intraoral prevalence of Veillonella parvula
Time frame: change from baseline to 2, 4, 7 and 14 days
change of the intraoral prevalence of Actinomyces viscosus
Time frame: change from baseline to 2, 4, 7 and 14 days
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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Heinrich-Heine University, Duesseldorf