Development of a Molecular Diagnosing Platform for Relieving Periodontal Symptoms

NCT03345329 | Completed

• 1 other identifier: 201506030
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontal Diseases; Peri-Implantitis

Outcome Measures

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.

  9 month

Study Arms (3)

Periodontal patient

Healthy person

Peri-implantitis patient

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• General Biologicals Corporation: lead

MeSH Terms

Conditions

Periodontal Diseases; Peri-Implantitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: November 17, 2017
• Study Start: October 1, 2015
• Primary Completion: March 30, 2016
• Study Completion: September 30, 2016
• Last Updated: November 17, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share