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

NCT03351530 | Unknown

• 1 other identifier: 16CT044be
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Periodontal Diseases

Outcome Measures

Primary Outcomes (11)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (5)

Pre-diabetes

Diabetes

Diabetes with periodontal disease

Periodontal patient

Healthy person

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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%

You may qualify if:

• HbAlC≧6.5%
• Glucose(AC)≧126 mg/dL
• h PG≧200mg/dL during an OGTT
• (1) 16 natural teeths and 6 front teeth at lesat (2) Periodontal pocket≧7 mm, and radiographic bone loss≧30%

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
• Mackay Memorial Hospital: collaborator

Study Sites (1)

General Biologicals Corporation

Hsinchu, Taiwan

Location

Related Publications (5)

• 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.

  PMID: 24478074 BACKGROUND

• 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.

  PMID: 24748407 BACKGROUND

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

  PMID: 25534621 BACKGROUND

• 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.

  PMID: 9722690 BACKGROUND

• 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.

  PMID: 21709707 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Periodontal Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; 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 9, 2017
• First Posted: November 24, 2017
• Study Start: May 18, 2017
• Primary Completion: December 9, 2018
• Study Completion: February 9, 2019
• Last Updated: November 24, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)