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PeriodontitisNCT00155571

The Occurrence of Periopathogens in Betel-Nut Chewers and the Effects of Areca-Nut on Periopathogens

An observational study of Periodontitis, run by National Taiwan University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Periodontitis
How many people
186 participants
Where
1 siteTaiwan
Study dates
Aug 2001to not given
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Adult, Older adult

Who may be able to join

  • Smoker/periodontitis Betel nut chewer/periodontitis Healthy

Who cannot join

  • systemic disease

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • National Taiwan Univerity hospital

    Dawan, 100

Other trials in Taiwan

About this study

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.

Read the 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.

Conditions
Periodontitis
Keywords
betel nut, periodontitis, periodontal microbiology
Medical subject headings
Periodontitis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study startAug 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Defined population
Time perspective
Other
Enrolment
186 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00155571
Sponsor's protocol ID
14881
Other IDs
NSC-90-2314-B-002-357
Status last verified
Jan 2001
First submitted
9 Sep 2005
Last updated
28 Nov 2005
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Periodontitis, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2005.

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