The Influence of Rumex Acetosa L on the Intraoral Colonization With Porphyromonas Gingivalis (RPG-I)

Proanthocyanidin- Enriched Extract From Rumex Acetosa L. as a Prophylactic Agent Against Intraoral Colonization With Porphyromonas Gingivalis

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.

Study Overview

• Status: Completed
• Conditions: Periodontitis
• Intervention / Treatment: Other: Placebo; Other: Rumex acetosa L. extract

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• Germany
  • Duesseldorf, Germany, 40225
    • Department od Operative Dentistry, Periodontics and Endodontics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• generally healthy
• periodontally healthy with Periodontal Screening Index ≤ 2

Exclusion Criteria:

• antibiotic therapy within the previous 6 months
• allergies against mouthrinse components
• pregnancy or lactation
• soft tissue lesions (e.g. lichen planus, leukoplakia)
• history of periodontal disease and/ or PSI ≥ 3 or more
• any topical or systemical medication, that potentially influence any immunological parameters
• any systemic disease or medical condition (e.g. diabetes or immunological disorders), that potentially influence the immune response or compromise the study results
• any systemic conditions, that require an antibiotic coverage for routine dental procedures (e.g. endocarditis)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Rumex acetosa L. extract; Rumex acetosa L. extract mouthrinse, 10 ml, tid, 3 min, 7 days	Other: Rumex acetosa L. extract
Placebo Comparator: Placebo; Placebo mouthrinse, 10 ml, tid, 3 min, 7 days	Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
change of the intraoral prevalence of Porphyromonas gingivalis	change from baseline to 2, 4, 7 and 14 days

Secondary Outcome Measures

Outcome Measure	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	change from baseline to 7 days

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Investigators: Principal Investigator: Thomas Beikler, Prof., Heinrich-Heine-University

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: January 16, 2014
• First Submitted That Met QC Criteria: January 16, 2014
• First Posted (Estimate): January 17, 2014

Study Record Updates

• Last Update Posted (Estimate): January 17, 2014
• Last Update Submitted That Met QC Criteria: January 16, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: Periodontitis; Porphyromonas gingivalis; Proanthocyanidins; Rumex acetosa L.
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: NRW 300262502