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CompletedNCT03345329Updated Nov 17, 2017

Development of a Molecular Diagnosing Platform for Relieving Periodontal Symptoms

An observational study in Periodontal Diseases and Peri-Implantitis, sponsored by General Biologicals Corporation. Completed. Open to participants aged 25 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-17.

Sponsored by General Biologicals Corporation · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
100
Ages
25 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Periodontal Diseases
  • Peri-Implantitis
03

Who can participate

Ages eligible
25 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

  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

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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • Periodontal patient
  • Healthy person
  • Peri-implantitis patient
05

What researchers measure

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

    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.

    Time frame: 9 month

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03345329
Lead sponsor
General Biologicals Corporation
Responsible party
Sponsor
First posted
Nov 17, 2017
Start date
Oct 1, 2015
Primary completion
Mar 30, 2016
Completion
Sep 30, 2016
Last update
Nov 17, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.

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