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Completed

NCT Number: NCT02039648

The Influence of Rumex Acetosa L on the 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Department od Operative Dentistry, Periodontics and Endodontics

Düsseldorf, 40225, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Rumex acetosa L. extract

Other

Placebo

Other

Primary outcomes

  1. change of the intraoral prevalence of Porphyromonas gingivalis

    Time frame: change from baseline to 2, 4, 7 and 14 days

Secondary outcomes

  1. change of the Approximal Plaque Index

    Time frame: change from baseline to 7 and 14 days

  2. change of the Sulcular Bleeding Index

    Time frame: change from baseline to 7 and 14 days

  3. change of the cytopathological appearance of the mucosal tissue

    Time frame: change from baseline to 7 days

Other outcomes

  1. change of the intraoral prevalence of Aggregatibacter actinomycetemcomitans

    Time frame: change from baseline to 2, 4,7, and 14 days

  2. change of the intraoral prevalence of Treponema denticola

    Time frame: change from baseline to 2, 4, 7, and 14 days

  3. change of the intraoral prevalence of Tannerella forsythia

    Time frame: change from baseline to 2, 4, 7 and 14 days

  4. change of the intraoral prevalence of Prevotella intermedia

    Time frame: change from baseline to 2, 4, 7 and 14 days

  5. change of the intraoral prevalence of Prevotella nigrescens

    Time frame: change from baseline to 2, 4, 7 and 14 days

  6. change of the intraoral prevalence of Eikenella corrodens

    Time frame: change from baseline to 2, 4, 7 and 14 days

  7. change of the intraoral prevalence of Streptococcus mutans

    Time frame: change from baseline to 2, 4, 7 and 14 days

  8. change of the intraoral prevalence of Candida albicans

    Time frame: change from baseline to 2, 4, 7 and 14 days

  9. change of the intraoral prevalence of Streptococcus sanguinis

    Time frame: change from baseline to 2, 4, 7 and 14 days

  10. change of the intraoral prevalence of Streptococcus mitis

    Time frame: change from baseline to 2, 4, 7 and 14 days

  11. change of the intraoral prevalence of Veillonella parvula

    Time frame: change from baseline to 2, 4, 7 and 14 days

  12. change of the intraoral prevalence of Actinomyces viscosus

    Time frame: change from baseline to 2, 4, 7 and 14 days

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Official study title

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

Acronym: RPG-I

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 17, 2014
Registry last updated
Jan 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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