Development of a Molecular Diagnosing Platform for Relieving Periodontal Symptoms

Completed

• Conditions: Peri-Implantitis; Periodontal Diseases

• Registration Number: NCT03345329
• Lead Sponsor: General Biologicals Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-01
• Primary Completion: 2016-03-30
• Study Completion: 2016-09-30
• Status Verified: 2017-11
• Study First Submitted: 2017-11-10
• Study First Submitted QC: 2017-11-15
• Last Update Submitted: 2017-11-15
• Study First Posted: 2017-11-17
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.