Development of a Molecular Diagnosing Platform for Relieving Periodontal Symptoms

Periodontal Diseases Clinical Trial

Official title:

Development of a Molecular Diagnosing Platform for Relieving Periodontal Symptoms

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03345329
• Other study ID #: 201506030
• Status: Completed
• Phase: N/A
• First received: November 10, 2017
• Last updated: November 15, 2017
• Start date: October 1, 2015
• Est. completion date: September 30, 2016

Study information

• Verified date: November 2017
• Source: General Biologicals Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 30, 2016
• Est. primary completion date: March 30, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gingival Diseases
• Peri-Implantitis
• Periodontal Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
General Biologicals Corporation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	9 month