Clinical trial NCT03351530: Development of a Molecular Diagnosing Platform for Monitoring Oral Hygiene in Diabetic Patients
Official title: Development of a Molecular Diagnosing Platform for Monitoring Oral Hygiene in Diabetic Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus
Periodontal Diseases
Lead sponsor: General Biologicals Corporation
Sponsor class: INDUSTRY
Collaborators: name: Mackay Memorial Hospital
First posted: 2017-11-24
Enrollment: 120
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. 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. Periodontal disease

(1) 16 natural teeths and 6 front teeth at lesat (2) Periodontal pocket≧7 mm, and radiographic bone loss≧30%

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.


Eligibility criteria: 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

Primary outcomes:
measure: The change of glucose (AC) between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
timeFrame: 6 month
measure: The change of HbAlC between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
timeFrame: 6 month
measure: The change of cholesterol total between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
timeFrame: 6 month
measure: The change of triglyceride between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
timeFrame: 6 month
measure: The change of LDL between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
timeFrame: 6 month
measure: The change of HDL between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
timeFrame: 6 month
measure: The change of uric acid between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
timeFrame: 6 month
measure: The change of GPT between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
timeFrame: 6 month
measure: The change of creatinine between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
timeFrame: 6 month
measure: The change of micro-albumin between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
timeFrame: 6 month
measure: The change of hs-CRP between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Hsinchu
country: Taiwan
facility: General Biologicals Corporation
Study officials:
References:
citation: Nagaoka K, Yanagihara K, Morinaga Y, Nakamura S, Harada T, Hasegawa H, Izumikawa K, Ishimatsu Y, Kakeya H, Nishimura M, Kohno S. Prevotella intermedia induces severe bacteremic pneumococcal pneumonia in mice with upregulated platelet-activating factor receptor expression. Infect Immun. 2014 Feb;82(2):587-93. doi: 10.1128/IAI.00943-13. Epub 2013 Nov 18.
citation: Suzuki J, Imai Y, Aoki M, Fujita D, Aoyama N, Tada Y, Wakayama K, Akazawa H, Izumi Y, Isobe M, Komuro I, Nagai R, Hirata Y. Periodontitis in cardiovascular disease patients with or without Marfan syndrome--a possible role of Prevotella intermedia. PLoS One. 2014 Apr 18;9(4):e95521. doi: 10.1371/journal.pone.0095521. eCollection 2014.
citation: Hajishengallis G. Periodontitis: from microbial immune subversion to systemic inflammation. Nat Rev Immunol. 2015 Jan;15(1):30-44. doi: 10.1038/nri3785.
citation: Grossi SG, Genco RJ. Periodontal disease and diabetes mellitus: a two-way relationship. Ann Periodontol. 1998 Jul;3(1):51-61. doi: 10.1902/annals.1998.3.1.51.
citation: Lalla E, Papapanou PN. Diabetes mellitus and periodontitis: a tale of two common interrelated diseases. Nat Rev Endocrinol. 2011 Jun 28;7(12):738-48. doi: 10.1038/nrendo.2011.106.