Department od Operative Dentistry, Periodontics and Endodontics
Düsseldorf, 40225, Germany
NCT Number: NCT02039648
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.
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Notify Me18 year and older
All sexes
Interventional
Early Phase 1
Düsseldorf, 40225, Germany
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: change from baseline to 2, 4, 7 and 14 days
Time frame: change from baseline to 7 and 14 days
Time frame: change from baseline to 7 and 14 days
Time frame: change from baseline to 7 days
Time frame: change from baseline to 2, 4,7, and 14 days
Time frame: change from baseline to 2, 4, 7, and 14 days
Time frame: change from baseline to 2, 4, 7 and 14 days
Time frame: change from baseline to 2, 4, 7 and 14 days
Time frame: change from baseline to 2, 4, 7 and 14 days
Time frame: change from baseline to 2, 4, 7 and 14 days
Time frame: change from baseline to 2, 4, 7 and 14 days
Time frame: change from baseline to 2, 4, 7 and 14 days
Time frame: change from baseline to 2, 4, 7 and 14 days
Time frame: change from baseline to 2, 4, 7 and 14 days
Time frame: change from baseline to 2, 4, 7 and 14 days
Time frame: change from baseline to 2, 4, 7 and 14 days
Heinrich-Heine University, Duesseldorf
Other
Proanthocyanidin- Enriched Extract From Rumex Acetosa L. as a Prophylactic Agent Against Intraoral Colonization With Porphyromonas Gingivalis
Acronym: RPG-I
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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