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Development of a Molecular Diagnosing Platform for Relieving Periodontal Symptoms

Sponsor
General Biologicals Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT03345329
Collaborator
(none)
100
Enrollment
12
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Development of a Molecular Diagnosing Platform for Relieving Periodontal Symptoms
    Actual Study Start Date :
    Oct 1, 2015
    Actual Primary Completion Date :
    Mar 30, 2016
    Actual Study Completion Date :
    Sep 30, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    Periodontal patient
    Healthy person
    Peri-implantitis patient

    Outcome Measures

    Primary Outcome Measures

    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 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Age≧25

    2. 3≦periodontal screening and recording≦4

    3. 16 natural teeths and 6 front teeth at lesat

    4. GI≧1.25

    5. PI≧2

    Exclusion Criteria:

    1. People who have oral lesion, dental braces, denture, mouthwash allergy, or serious systemic disease

    2. People who have ever eaten antibiotics and Anti-inflammatory drugs over the last 6 months

    3. People who have ever eaten Immunosuppressive drugs, antiepileptic drugs, antihypertensive drugs, or anticoagulant

    4. Pregnant women or the woman who eat birth control pills

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • General Biologicals Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    General Biologicals Corporation
    ClinicalTrials.gov Identifier:
    NCT03345329
    Other Study ID Numbers:
    • 201506030
    First Posted:
    Nov 17, 2017
    Last Update Posted:
    Nov 17, 2017
    Last Verified:
    Nov 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Periodontal Diseases
    Peri-Implantitis

    Study Results

    No Results Posted as of Nov 17, 2017