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OpenTrials
Completed

NCT Number: NCT03345329

Development of a Molecular Diagnosing Platform for Relieving Periodontal Symptoms

More than ninety percent of adults in Taiwan are suspected to carry periodontal disease, which causes bad breath, swollen and bleeding gums, plaque and even tooth loss. Half of the patients, however, are ignorance these clinical syndromes because of no obvious pain. In this study, the investigators selected six periodontal disease-associated bacteria strains, including Porphyromonas gingivalis (Pg), Fusobacterium nucleatum (Fn), Actinobacillus actinomycetemcomitans (Aa), Tannerella forsythia (Tf), Treponema denticola (Td) and Prevotella intermedia (Pi) as diagnostic markers. Using real-time PCR and MALDI Biotyper, the investigators will establish the database of oral microorganisms in Taiwanese people, providing periodontal disease clinical markers of high-risk groups and the basis for personal medicine of therapy in the future.

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Key information

Conditions

Periodontal Diseases Mouth Diseases Peri-Implantitis Stomatognathic Diseases

Age range

25 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age≧25
  • 3≦periodontal screening and recording≦4
  • 16 natural teeths and 6 front teeth at lesat
  • GI≧1.25
  • PI≧2

Exclusion criteria

  • People who have oral lesion, dental braces, denture, mouthwash allergy, or serious systemic disease
  • People who have ever eaten antibiotics and Anti-inflammatory drugs over the last 6 months
  • People who have ever eaten Immunosuppressive drugs, antiepileptic drugs, antihypertensive drugs, or anticoagulant
  • Pregnant women or the woman who eat birth control pills

Treatment and study plan

Primary outcomes

  1. The change of PSR score, GI, PI, and oral bacteria strains between periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash

    Time frame: 9 month

    To compare the value of PSR score (0-4 point), GI (0-4 point), and PI (0-5 point) with periodontal disease patients older than 60 years of age, periodontal disease patients younger than 60 years of age and healthy people after receiving periodontal therapy and using mouthwash. Oral bacteria strains are also compared with these groups.

Sponsors and collaborators

Lead sponsor

General Biologicals Corporation

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 17, 2017
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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