The Influence of Rumex Acetosa L on the Intraoral Colonization With Porphyromonas Gingivalis (RPG-I)
Primary Purpose
Periodontitis
Status
Completed
Phase
Early Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Rumex acetosa L. extract
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Periodontitis focused on measuring Periodontitis, Porphyromonas gingivalis, Rumex acetosa L., Proanthocyanidins
Eligibility Criteria
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)
Sites / Locations
- Department od Operative Dentistry, Periodontics and Endodontics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Rumex acetosa L. extract
Placebo
Arm Description
Rumex acetosa L. extract mouthrinse, 10 ml, tid, 3 min, 7 days
Placebo mouthrinse, 10 ml, tid, 3 min, 7 days
Outcomes
Primary Outcome Measures
change of the intraoral prevalence of Porphyromonas gingivalis
Secondary Outcome Measures
change of the Approximal Plaque Index
change of the Sulcular Bleeding Index
change of the cytopathological appearance of the mucosal tissue
Full Information
NCT ID
NCT02039648
First Posted
January 16, 2014
Last Updated
January 16, 2014
Sponsor
Heinrich-Heine University, Duesseldorf
1. Study Identification
Unique Protocol Identification Number
NCT02039648
Brief Title
The Influence of Rumex Acetosa L on the Intraoral Colonization With Porphyromonas Gingivalis
Acronym
RPG-I
Official Title
Proanthocyanidin- Enriched Extract From Rumex Acetosa L. as a Prophylactic Agent Against Intraoral Colonization With Porphyromonas Gingivalis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Heinrich-Heine University, Duesseldorf
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Periodontitis, Porphyromonas gingivalis, Rumex acetosa L., Proanthocyanidins
7. Study Design
Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rumex acetosa L. extract
Arm Type
Active Comparator
Arm Description
Rumex acetosa L. extract mouthrinse, 10 ml, tid, 3 min, 7 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo mouthrinse, 10 ml, tid, 3 min, 7 days
Intervention Type
Other
Intervention Name(s)
Rumex acetosa L. extract
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
change of the intraoral prevalence of Porphyromonas gingivalis
Time Frame
change from baseline to 2, 4, 7 and 14 days
Secondary Outcome Measure Information:
Title
change of the Approximal Plaque Index
Time Frame
change from baseline to 7 and 14 days
Title
change of the Sulcular Bleeding Index
Time Frame
change from baseline to 7 and 14 days
Title
change of the cytopathological appearance of the mucosal tissue
Time Frame
change from baseline to 7 days
Other Pre-specified Outcome Measures:
Title
change of the intraoral prevalence of Aggregatibacter actinomycetemcomitans
Time Frame
change from baseline to 2, 4,7, and 14 days
Title
change of the intraoral prevalence of Treponema denticola
Time Frame
change from baseline to 2, 4, 7, and 14 days
Title
change of the intraoral prevalence of Tannerella forsythia
Time Frame
change from baseline to 2, 4, 7 and 14 days
Title
change of the intraoral prevalence of Prevotella intermedia
Time Frame
change from baseline to 2, 4, 7 and 14 days
Title
change of the intraoral prevalence of Prevotella nigrescens
Time Frame
change from baseline to 2, 4, 7 and 14 days
Title
change of the intraoral prevalence of Eikenella corrodens
Time Frame
change from baseline to 2, 4, 7 and 14 days
Title
change of the intraoral prevalence of Streptococcus mutans
Time Frame
change from baseline to 2, 4, 7 and 14 days
Title
change of the intraoral prevalence of Candida albicans
Time Frame
change from baseline to 2, 4, 7 and 14 days
Title
change of the intraoral prevalence of Streptococcus sanguinis
Time Frame
change from baseline to 2, 4, 7 and 14 days
Title
change of the intraoral prevalence of Streptococcus mitis
Time Frame
change from baseline to 2, 4, 7 and 14 days
Title
change of the intraoral prevalence of Veillonella parvula
Time Frame
change from baseline to 2, 4, 7 and 14 days
Title
change of the intraoral prevalence of Actinomyces viscosus
Time Frame
change from baseline to 2, 4, 7 and 14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Beikler, Prof.
Organizational Affiliation
Heinrich-Heine-University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department od Operative Dentistry, Periodontics and Endodontics
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
The Influence of Rumex Acetosa L on the Intraoral Colonization With Porphyromonas Gingivalis
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