- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00155571
The Occurrence of Periopathogens in Betel-Nut Chewers and the Effects of Areca-Nut on Periopathogens
November 25, 2005 updated by: National Taiwan University Hospital
Periodontal disease is considered to be an infection disease.
Recent evidence supported the role of smoking as a potent risk factor for the development of periodontal disease.
However, the effect of another oral habit, betel quid chewing on periodontal tissues has not been well determined.
The purpose of the present study is to analysis the role of bacteria on the periodontium in the betel quid chewers.
Plaque samples will be collected from betel quid chewers and the occurrence of periodotopathogens will be analyzed Since most chewers also smokers, plaque samples from age matched smokers but not betel chewers and non-smokers will analysis for comparison.
An in vitro test is also performed to evaluate whether the extract has a direct inhibitory effect on common periodontal pathogens, such as Porphyromoans gingivalis, Bacteroides forsythus, Actinobacillus actinomycetemcomitans.
Study Overview
Status
Completed
Conditions
Detailed Description
Periodontal disease is considered to be an infection disease.
Specific microorganisms especially the gram-negative anaerobic bacteria gain predominance in periodontal pockets and challenge the host.
Lipopolysaccharides of the bacteria and other virulence factors will interact with macrophages and active cells to synthesis large quantities of IL-1, TNF, PgE2 and matrix metalloproteinases and lead to the degradation of the collagen and bone destruction.
It has been shown that the genetic or environmental factors can modulate the initiation and progression of periodontal disease.
Recent evidence supported the role of smoking as a potent risk factor for the development of periodontal disease.
However, the effect of another oral habit, betel quid chewing on periodontal tissues has not been well determined.
Earlier epidemiological studies have shown a detrimental effect on periodontal tissues.
Higher prevalence of periodontal disease among betel chewers than among non-chewers was found, even when subgroups of similar oral hygiene were compared.
In vitro studies also support the nut extract has a cytopathologic effects on gingival fibroblast.
The extract or the major betel nut alkaloid, arecoline, can inhibit the growth, attachment and matrix protein synthesis of gingival fibroblast.
Study also showed that ripe and tender extract can reduce the antibacterial activity of neutrophils in vitro.
However, most earlier epidemiological studies did not adjust the potentially confounding variables such as age, socioeconomic status, oral hygiene.
Besides, most chewers are also smokers and drinkers, whether the higher periodontal index may contribute from the smoking habit, or betel quid chewing or the combination of both habits cannot be determined.
Conversely, it is also found that the betel nut has an antibacterial properties and prolonged exposure can suppress the salivary organisms.
It is also used for treating bleeding gums in ancient Indian medicine.
Inhibitory effect on Streptococcus mutans, Streptococcus salivarius, Fusbobacerium nucleatum was shown, but there are no any data concerning the effect on the periodontal pathogens.
Since the challenge of the bacteria is essential to initiate the disease process, the presence of more virulence types of plaque bacteria may increase the risk and the rate of progression of periodontal disease.
It is not known whether the extract can affect the composition of the dental plaque through changing the oral ecology such as the pH value of the saliva, a direct inhibitory effect on the periodontal microorganism or through inhibiting the colonization of the Streptococcus, and then prevent the further succession of another bacterial complex.
The purpose of the present study is to analysis the role of bacteria on the periodontium in the betel quid chewers.
Plaque samples will be collected from betel quid chewers and the occurrence of periodotopathogens will be analyzed Since most chewers also smokers, plaque samples from age matched smokers but not betel chewers and non-smokers will analysis for comparison.
An in vitro test is also performed to evaluate whether the extract has a direct inhibitory effect on common periodontal pathogens, such as Porphyromoans gingivalis, Bacteroides forsythus, Actinobacillus actinomycetemcomitans.
Study Type
Observational
Enrollment
186
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taiwan, Taiwan, 100
- National Taiwan Univerity hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Smoker/periodontitis Betel nut chewer/periodontitis Healthy
Exclusion Criteria:
systemic disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Defined Population
- Time Perspectives: Other
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Man-ying Wang, DDS, MS, Department of Periodontics, National Taiwan University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2001
Primary Completion
December 7, 2022
Study Completion
December 7, 2022
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 9, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
November 28, 2005
Last Update Submitted That Met QC Criteria
November 25, 2005
Last Verified
January 1, 2001
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14881
- NSC-90-2314-B-002-357
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Periodontitis
-
Azienda Socio Sanitaria Territoriale degli Spedali...Università degli Studi di FerraraCompletedPeriodontitis, Aggressive | Periodontitis, AdultItaly
-
Panineeya Mahavidyalaya Institute of Dental Sciences...Research Institute for Genetic and Human TherapyUnknownGeneralized Adult Periodontitis
-
Asem Mohammed Kamel AliCompletedMolar-incisor Pattern Grade C Periodontitis ( Localized Aggressive Periodontitis) | Generalized Grade C Periodontitis (Generalized Aggressive Periodontitis)Egypt
-
Columbia UniversityCompletedPeriodontal Diseases | Generalized Moderate Chronic Periodontitis | Generalized Severe Chronic PeriodontitisUnited States
-
Postgraduate Institute of Dental Sciences RohtakUnknownChronic Apical PeriodontitisIndia
-
University of SienaNot yet recruitingPeriodontitis, AdultItaly
-
Lithuanian University of Health SciencesCompleted
-
Louisiana State University Health Sciences Center...CompletedPeriodontitis, AdultUnited States
-
University of BergenCompletedPeriodontitis | Adult Periodontitis
-
Cairo UniversityUnknownPeriodontitis, AdultEgypt