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.
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.
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.
- First posted12 Sep 2005 (estimated)
- Study startAug 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Investigators
- Man-ying Wang, DDS, MS, Principal investigator, Department of Periodontics, National Taiwan University Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Occurrence of Periopathogens in Betel-Nut Chewers and the Effects of Areca-Nut on Periopathogens
- ClinicalTrials.gov ID
- NCT00155571
- Acronym / sponsor ID
- 14881
- Conditions
- Periodontitis
- Keywords
- betel nut, periodontitis, periodontal microbiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2001
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Smoker/periodontitis Betel nut chewer/periodontitis Healthy
Key exclusion criteria (1 listed)
- systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Man-ying Wang, DDS, MS principal investigator
Department of Periodontics, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
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.