The Influence of Rumex Acetosa L on the Intraoral Colonization With Porphyromonas Gingivalis

Periodontitis Clinical Trial

— RPG-I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02039648
• Other study ID #: NRW 300262502
• Status: Completed
• Phase: Phase 0
• First received: January 16, 2014
• Last updated: January 16, 2014
• Start date: March 2012
• Est. completion date: April 2013

Study information

• Verified date: January 2014
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Periodontitis

Intervention

Other:
• Rumex acetosa L. extract

• Placebo

Locations

Country	Name	City	State
Germany	Department od Operative Dentistry, Periodontics and Endodontics	Duesseldorf

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	change of the intraoral prevalence of Aggregatibacter actinomycetemcomitans		change from baseline to 2, 4,7, and 14 days	No
Other	change of the intraoral prevalence of Treponema denticola		change from baseline to 2, 4, 7, and 14 days	No
Other	change of the intraoral prevalence of Tannerella forsythia		change from baseline to 2, 4, 7 and 14 days	No
Other	change of the intraoral prevalence of Prevotella intermedia		change from baseline to 2, 4, 7 and 14 days	No
Other	change of the intraoral prevalence of Prevotella nigrescens		change from baseline to 2, 4, 7 and 14 days	No
Other	change of the intraoral prevalence of Eikenella corrodens		change from baseline to 2, 4, 7 and 14 days	No
Other	change of the intraoral prevalence of Streptococcus mutans		change from baseline to 2, 4, 7 and 14 days	No
Other	change of the intraoral prevalence of Candida albicans		change from baseline to 2, 4, 7 and 14 days	No
Other	change of the intraoral prevalence of Streptococcus sanguinis		change from baseline to 2, 4, 7 and 14 days	No
Other	change of the intraoral prevalence of Streptococcus mitis		change from baseline to 2, 4, 7 and 14 days	No
Other	change of the intraoral prevalence of Veillonella parvula		change from baseline to 2, 4, 7 and 14 days	No
Other	change of the intraoral prevalence of Actinomyces viscosus		change from baseline to 2, 4, 7 and 14 days	No
Primary	change of the intraoral prevalence of Porphyromonas gingivalis		change from baseline to 2, 4, 7 and 14 days	No
Secondary	change of the Approximal Plaque Index		change from baseline to 7 and 14 days	No
Secondary	change of the Sulcular Bleeding Index		change from baseline to 7 and 14 days	No
Secondary	change of the cytopathological appearance of the mucosal tissue		change from baseline to 7 days	Yes