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Development of a Molecular Diagnosing Platform for Monitoring Oral Hygiene in Diabetic Patients

Development of a Molecular Diagnosing Platform for Monitoring Oral Hygiene in Diabetic Patients

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03351530
Enrollment
120
Registered
2017-11-24
Start date
2017-05-18
Completion date
2019-02-09
Last updated
2017-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Periodontal Diseases

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. A lot of researches show that periodontal disease is related to diabetes mellitus. Periodontal disease causes rise of blood sugar, and more than 3 times as diabetes mellitus patients as healthy people have serious periodontal disease.In this study, the investigators collect periodontal pocket and saliva samples of participants, and selecting six periodontal disease-associated bacteria strains, including Porphyromonas gingivalis (Pg), Fusobacterium nucleatum (Fn), Actinobacillus actinomycetemcomitans (Aa), Treponema denticola (Td), Prevotella intermedia (Pi) and Tannerella forsythia (Tf) as diagnostic markers. Participants will get bacteriostasis mouthwash at mouth 2. The investigators will compare the differences of blood biochemistry value and oral bacteria strains after using the mouthwash.Using real-time PCR and MALDI Biotyper, the investigators will establish the database of oral microorganisms in diabetes mellitus patients, providing periodontal disease clinical markers of high-risk groups and the basis for personal medicine of therapy in the future.

Interventions

None listed

Sponsors

Mackay Memorial Hospital
CollaboratorOTHER
General Biologicals Corporation
Lead SponsorINDUSTRY

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
25 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

1\. Inclusion condition of diabetes: 1. HbAlC≧6.5% 2. Glucose(AC)≧126 mg/dL 3. 2-h PG≧200mg/dL during an OGTT 4. In a patient with classic symptoms of hyperglycemia or hyperglycemic crisis, a random plasma glucose≧200mg/dL 2. Inclusion condition of periodontal disease (1) 16 natural teeths and 6 front teeth at lesat (2) Periodontal pocket≧7 mm, and radiographic bone loss≧30%

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

Design outcomes

Primary

MeasureTime frameDescription
The change of glucose (AC) between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash6 monthTo compare the value of glucose (AC) in mg/dL with diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash.
The change of HbAlC between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash6 monthTo compare the value of HbAlC in % with diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash.
The change of cholesterol total between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash6 monthTo compare the value of cholesterol total in mg/dL with diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
The change of triglyceride between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash6 monthTo compare the value of triglyceride in mg/dL with diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
The change of LDL between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash6 monthTo compare the value of LDL in mg/dL with diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
The change of HDL between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash6 monthTo compare the value of HDL in mg/dL with diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
The change of uric acid between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash6 monthTo compare the value of uric acid in mg/dL with diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
The change of GPT between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash6 monthTo compare the value of GPT in U/L with diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
The change of creatinine between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash6 monthTo compare the value of creatinine in mg/dL with diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
The change of micro-albumin between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash6 monthTo compare the value of micro-albumin in mg/L with diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
The change of hs-CRP between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash6 monthTo compare the value of hs-CRP in mg/dL with diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026