ESTIMATION OF BLOOD SUGAR IN CHRONIC PERIODONTITIS PATIENTS.
- Conditions
- 1.Cases: (Group I) total of 50 subjects with chronic periodontitis 2.Control: (Group II) includes 50 subjects without chronic periodontitis.
- Registration Number
- CTRI/2014/01/004356
- Lead Sponsor
- PRIYANKA CHAND KAUSHIK
- Brief Summary
summary Periodontal disease isa common, chronic, complex multifactorial disease characterized by destruction andloss of connective tissue attachment. The mostprevalent form is chronic periodontitis. There is increasingevidence that microbial biofilm and host susceptibility plays an important rolein initiation and progression of periodontitis[1](#_ENREF_1 "Schenkein, 2006 #922").Recent studies have demonstrated that chronic periodontitis is a potential riskfactor for systemic diseases like coronary heart diseases/atherosclerosis, worseningglycemic control in diabetes mellitus, adverse pregnancy outcome etc[2](#_ENREF_2 "Lindhe, 2003 #718").Periodontal disease has now be recognized as the sixth complication of diabetes[3](#_ENREF_3 "Loe, 1993 #3").Diabetes mellitus is a common multifactorial disease process involving genetic,environmental and behavioral risk factors affecting up to 5% of the generalpopulation of world[4](#_ENREF_4 "King, 1998 #720").India leads the world with largest number of diabetic subjects to around 40.9million[5](#_ENREF_5 "Mohan, 2007 #4").In Kerala, Kutty et. al reported 16.3 percent crude prevalence of diabetesmellitus among adults aged 20 years or above in an urban settlement[6](#_ENREF_6 "Raman Kutty V, 1999 #72").
Numerous epidemiologic surveys demonstratedthat there is an increased prevalence of periodontitis among patients withuncontrolled or poorly controlled diabetes mellitus[7](#_ENREF_7 "Taylor, 2001 #28").Evidence has consistently indicated that diabetes is a risk factor forincreased severity of gingivitis and periodontitis8. Conversely,periodontitis may be a risk factor for worsening glycemic control. Althoughthe biologic mechanisms linking periodontitis to impaired glucose metabolismhave not been fully elucidated. Inflammatorymediators(particularly interleukin-1, interleukin-6 and tumor necrosis factor-alpha)generated within the inflamed periodontal tissues translocate into the systemiccirculation and interfere with the actions of insulin receptors, therebydecreasing insulin sensitivity associated with degree of glycemic control of diabetes9. These inflammatory mediators (IL-1), IL-6,(TNF-*α*) and prostaglandinE2 (PGE2) can interact systemically with lipids, freefatty acids and advanced glycation end products (AGES). This interactioninduces or perpetuates activation of the intracellular pathways, such as theI-kappa-B (I*κ*B), I-kappa-B kinase-*β* (IKK*β*), nuclearfactor-kappa B (NF-k*β*) and the protein c-Jun *N*-terminalkinase (JNK) axes. The activation of these inflammatory pathways in immunecells (monocytes or macrophages), endothelium cells, adipocytes, hepatocytesand muscle cells promotes and contributes to an increase in the overall insulinresistance, which makes itdifficult to achieve metabolic control in patients with both type 2 diabetesand periodontitis10 .In 2010 American Diabetes Association Standardsof Medical care in Diabetes added the A1c ≥ 48 mmol/mol (≥6.5%) as anothercriterion for the diagnosis of diabetes11**.** People without diabetes usually have a level of 4.5% - 6%.So,in between....6.0-6.5...may be ’pre-diabetes’ or ’at risk of diabetes’. (WHO2010)
Although many studies reported more severeperiodontal disease in subjects with diabetes than those without diabetes, relativelyvery few examined the association between periodontitis and glycemia or thelevel of glycosylated hemoglobinin in adults without diabetes12. Saito et al.13 found that alveolar boneloss was associated with impaired glucose tolerance in Japanese men withoutdiabetes. Similarly Nibali et al.14 found slightly, butstatistically significantly, higher non-fasting glucose levels in periodontitiscases compared to healthy controls. These studies suggest that periodontitismay affect glucose metabolism in the general population, albeit to a lesserextent than in adults with diabetes.
So we hypothesized that patients with periodontitis have higher HbA1clevels than healthy patients and the purpose of this study is to examine theassociation between periodontitis and HbA1c level in otherwise systemicallyhealthy individuals.
**AIM**
Toidentify a possible association between chronic periodontitis and glycosylatedhemoglobin levels in otherwise systemically healthy individuals.
**OBJECTIVES**
1. Toassess glycosylated hemoglobin levels in otherwise systemically healthyindividuals with chronic periodontitis and compare it with a healthy controlgroup.
2. Tocorrelate the level of inflammatory marker like serum albumin and CRP withperiodontal parameters.
**METHODOLOGY**
**Study design**
Crossectional(observational) study
**MATERIALS AND METHODS**
**Study population andsample size**: Subjects in this study group tocomprise of 100 patients. Thesesubjects will be divided in to two groups.
1. **Cases: (Group I)** casesincludes total of 50 subjects otherwise systemically healthy patients withchronic periodontitis reporting to the department of periodontics GOVT DENTALCOLLEGE CALICUT.
2. **Control:****(Group II)** includes 50 subjectsotherwise systemically healthy without chronic periodontitis. Control shouldmatch for age, sex, and to cases. These subjects will undergo general, oral orperiodontal examination and laboratory investigations.
**Duration of the study**
18months.
**Study setting**
**Location**This study is to be conducted by the department of Periodontics, GOVT. DENTALCOLLEGE CALICUT in collaboration with department of biochemistry GOVT MEDICALCOLLEGE CALICUT.
**INCLUSION CRITERIA FORCASE GROUP**
1.Patients with age group between 25 to 55.
2.Minimum of 20 teeth present.
3.Patients who were diagnosed with severeperiodontitis chronic periodontitis (CDC criteria moderate periodontitis is defind as ≥2interproximal sites with ≥ 4mm clinicalattacment loss (CAL) not on same tooth,or ≥2 interproximal with probing depth(PD) ≥ 5mm not on same tooth severe periodontitis is defind as ≥2 teeth withclinical attachment loss ≥6mm not onsame tooth and ≥1 interproximal sitewith probing depth ≥ 5mm).
5.Nofamily history of Diabetes,
**INCLUSION CRITERIA FORCONTROL GROUP**
1. Healthyindividuals with age group between 25 to 55.
2. Minimumof 20 teeth present.
3. Subjectswho do not fall within the diagnostic criteria for moderate or severe periodontitis(CDC criteria)
4. Nofamily history of Diabetes
**EXCLUSION CRITERIA**
1. Patientswith known systemic disease and condition such as CVD, renal disease, RA,diabetes Mellitus, liver and pancreatic disease, nutritional deficiencies,pregnant and lactating mother.
2. Patients with conditions that shortenerythrocyte survival (e.g., hemolytic anemia, pregnancy, or recent significant blood loss, or who are positivefor rheumatoid factors.)
3. Patientswith acute condition that contraindicate a periodontal examination.
4. Patientswho received systemic antibiotic therapy within past 6 month.
5. Patientswho received periodontal therapy (scaling and root planing or surgery) past 1year.
6. Patientsnot willing to sign informed consent.
**ARMAMENTARIUM**
1. Mouthmirror
2. Explorer
3. Williamsgraduated periodontal probe
4. Disclosingagents
5. HbA1cassessment kit
6. CRPassessment kit
**DATACOLLECTION**
**DataCollection Tools**
1. Questionnaire
2. Clinicalexamination
3. Blood investigation
**Periodontal Parameters**
1. Probingdepth
2. Clinicalattachment level
3. Gingivalrecession
4. Simlifiedoral hygiene index
5. Plaqueindex
6. Modifiedgingival index
**SystemicParameters**
1. TCH
2. HDL
3. LDL
4. VLDL
5. TRIGLYCERIDES
6. BLOOD GLUCOSE (fasting and post prandial)
7. BP
8. BMI
9. WHR
10. GLYCOSYLATED HEMOGLOBIN
11. CRP
12. SERUMALBUMIN
**INFORMEDCONSENT**
Awritten informed consent will be obtained from all participants in the study .Demographicdata includes age, gender, weight, educational level, ethnicity, occupation, familyincome . Complete medical history includes diabetic history, history of CVD andhypertension, medication etc. The laboratory assays include, BMI, WHR, CRP, fastingblood sugar, total cholesterol, HDL, LDL, Triglycerides etc.
**DATA ANALYSIS**
(α value will be set at 5% and β value will beset at 80%)
QualitativeData by chi-square test
QuantitativeData by student ‘t’ test
Oddsratio & correlation coefficient
Multivariatelinear regression
**FUNDING** -Rs60000/-
**ANNEXURE**
1. PROFORMA
2. CONSENT
**REFERENCES**
1. Schenkein HA. Host responses in maintaining periodontalhealth and determining periodontal disease. *Periodontol2000* 2006;40:77-93.
2. Lindhe J, Karring T, Lang NP. *Clinical periodontology and implant dentistry*. Oxford ; Malden,Mass.: Blackwell Munksgaard; 2003: xxiv, 1044 p.
3. Loe H. Periodontal disease the sixth complication ofdiabetes mellitus. *Diabetes Care*1993;16:329-334.
4. King H, Aubert RE, Herman WH. Global burden of diabetes,1995-2025: prevalence, numerical estimates, and projections. *Diabetes Care* 1998;21:1414-1431
5. Mohan V, Sandeep S, Deepa R, Shah B, Varghese C.Epidemiology of type 2 diabetes: Indian scenario. *Indian J Med Res* 2007;125:217-230.
6. Raman Kutty V,Joseph A, CR S. High prevalence of type 2 diabetes in an urban settlement inKerala, India. *Ethn Health* 1999;4.
7. Taylor GW. Bidirectional interrelationships betweendiabetes and periodontal diseases: an epidemiologic perspective. *Ann Periodontol* 2001;6:99-112.
8. Mealey BL, Oates TW.Diabetes mellitus and periodontal diseases. *J Periodontol.*2006;77:1289-303.
9. Mealey BL,Ocampo GL. Diabetes mellitus and periodontal disease. Periodontol 20002007;44:127-153.
10.Roberta Santos Tunes.Impact of Periodontitis on theDiabetes-Related Inflammatory Status.*: J Can Dent Assoc2010;76:a35*
11.Standards of medical care in diabetes Care **33**(Suppl1) S4– 10 January 2010.
12. Ryan E. Wolff,\* Larry F. Wolff,†and Bryan S.Michalowicz. Pilot Study ofGlycosylated Hemoglobin Hemoglobin Levels in Periodontitis Cases and HealthyControls( J Periodontol 2009;80:1057-1061)
13. Saito T,Murakami M, Shimazaki Y, Matsumoto S, Yamashita Y. The extent of alveolar boneloss is associated with impaired glucose tolerance in Japanese men. JPeriodontol 2006;77:392-397.
14. Nibali L,D’Aiuto F, Griffiths G, Patel K, Suvan J,Tonetti MS. Severe periodontitis isassociated with systemic inflammationand a dysmetabolic status: A case-control study. J Clin Periodontol2007;34:931-937.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
- INCLUSION CRITERIA FOR CASE GROUP 1.Patients with age group between 25 to 55.
- 2.Minimum of 20 teeth present.
- 3.Patients who were diagnosed with severe and moderate chronic periodontitis (CDC criteria).
- 5.No family history of Diabetes.
- INCLUSION CRITERIA FOR CONTROL GROUP 1.Healthy individuals with age group between 25 to 55.
- 3.Subjects who do not fall within the diagnostic criteria for moderate or severe periodontitis (CDC criteria) 4.No family history of Diabetes.
- EXCLUSION CRITERIA 1.Patients with known systemic disease and condition such as CVD, renal disease, RA, diabetes Mellitus, liver and pancreatic disease, nutritional deficiencies, pregnant and lactating mother.
- Patients with conditions that shorten erythrocyte survival (e.g., hemolytic anemia, pregnancy, or recent significant blood loss, or who are positive for rheumatoid factors.) 3.Patients with acute condition that contraindicate a periodontal examination.
- 4.Patients who received systemic antibiotic therapy within past 6 month.
- 5.Patients who received periodontal therapy (scaling and root planing or surgery) past 1 year.
- 6.Patients not willing to sign informed consent.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To identify a possible association between chronic periodontitis and glycosylated hemoglobin levels in otherwise systemically healthy individuals. at time of patient selection
- Secondary Outcome Measures
Name Time Method 2.To correlate the level of inflammatory marker like serum albumin and CRP and fasting lipid profile,blood sugar with periodontal parameters. at time of patient selection
Trial Locations
- Locations (1)
DEPT.OF PERIODONTICS,GOVT.DENTAL COLLEGE
🇮🇳Kozhikode, KERALA, India
DEPT.OF PERIODONTICS,GOVT.DENTAL COLLEGE🇮🇳Kozhikode, KERALA, IndiaPRIYANKA CHAND KAUSHIKPrincipal investigator8590259896priyankapunit.mds@gmail.com