Development of a Molecular Diagnosing Platform for Relieving Periodontal Symptoms

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases; Peri-Implantitis

• Study Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Healthy person
Periodontal patient
Peri-implantitis patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: General Biologicals Corporation

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Actual): March 30, 2016
• Study Completion (Actual): September 30, 2016

Study Registration Dates

• First Submitted: November 10, 2017
• First Submitted That Met QC Criteria: November 15, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): November 17, 2017
• Last Update Submitted That Met QC Criteria: November 15, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Mouth Diseases; Periodontal Diseases; Peri-Implantitis
• Other Study ID Numbers: 201506030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No