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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03351530
• Other study ID #: 16CT044be
• Status: Enrolling by invitation
• Phase: N/A
• First received: November 9, 2017
• Last updated: November 19, 2017
• Start date: May 18, 2017
• Est. completion date: February 9, 2019

Study information

• Verified date: November 2017
• Source: General Biologicals Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. completion date: February 9, 2019
• Est. primary completion date: December 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Gingival Diseases
• Periodontal Diseases

Locations

Country	Name	City	State
Taiwan	General Biologicals Corporation	Hsinchu

Sponsors (2)

Lead Sponsor	Collaborator
General Biologicals Corporation	Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (5)

Grossi SG, Genco RJ. Periodontal disease and diabetes mellitus: a two-way relationship. Ann Periodontol. 1998 Jul;3(1):51-61. Review. — View Citation

Hajishengallis G. Periodontitis: from microbial immune subversion to systemic inflammation. Nat Rev Immunol. 2015 Jan;15(1):30-44. doi: 10.1038/nri3785. Review. — View 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of glucose (AC) between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash	To 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.	6 month
Primary	The change of HbAlC between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash	To compare the value of HbAlC in % with diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash.	6 month
Primary	The change of cholesterol total between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash	To 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	6 month
Primary	The change of triglyceride between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash	To 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	6 month
Primary	The change of LDL between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash	To 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	6 month
Primary	The change of HDL between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash	To 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	6 month
Primary	The change of uric acid between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash	To 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	6 month
Primary	The change of GPT between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash	To 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	6 month
Primary	The change of creatinine between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash	To 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	6 month
Primary	The change of micro-albumin between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash	To 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	6 month
Primary	The change of hs-CRP between diabetes mellitus patients, periodontal disease patients and healthy people after receiving periodontal therapy and using mouthwash	To 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	6 month