NCT02039648

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Mar 2012

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 17, 2014

Completed
Last Updated

January 17, 2014

Status Verified

January 1, 2014

Enrollment Period

1.1 years

First QC Date

January 16, 2014

Last Update Submit

January 16, 2014

Conditions

Periodontitis

Keywords

PeriodontitisPorphyromonas gingivalisRumex acetosa L.Proanthocyanidins

Outcome Measures

Primary Outcomes (1)

  • change of the intraoral prevalence of Porphyromonas gingivalis

    change from baseline to 2, 4, 7 and 14 days

Secondary Outcomes (3)

  • 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 Outcomes (12)

  • 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

  • +9 more other outcomes

Study Arms (2)

Rumex acetosa L. extract

ACTIVE COMPARATOR

Rumex acetosa L. extract mouthrinse, 10 ml, tid, 3 min, 7 days

Other: Rumex acetosa L. extract

Placebo

PLACEBO COMPARATOR

Placebo mouthrinse, 10 ml, tid, 3 min, 7 days

Other: Placebo

Interventions

Rumex acetosa L. extractOTHER
Rumex acetosa L. extract
PlaceboOTHER
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department od Operative Dentistry, Periodontics and Endodontics

Düsseldorf, 40225, Germany

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Thomas Beikler, Prof.

    Heinrich-Heine-University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2014

First Posted

January 17, 2014

Study Start

March 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

January 17, 2014

Record last verified: 2014-01

Locations

DE(1)