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A study to check the left ventricular mass in patients with gingivitis and chronic periodontitis having type II diabetes mellitus.

Phase 1
Completed
Conditions
Health Condition 1: null- Periodontitis and type II Diabetes Mellitus
Registration Number
CTRI/2016/01/006532
Lead Sponsor
Trupti Sarda
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
45
Inclusion Criteria

All patients >= 30 years of age and should have controlled type II Diabetes Mellitus since 5-10 years. All subjects should have seven or more remaining teeth and willing to participate and sign informed consent.

Group I â?? Periodontally healthy subjects assessed by no gingival inflammation and pocket probing depth < 3mm.

Group II â?? Subjects with gingival inflammation, pocket probing depth < 3mm and no clinical attachment loss.

Group III - Subjects with gingival inflammation, pocket probing depth >= 3mm and clinical attachment loss >= 3mm.

Exclusion Criteria

1. Subjects with history of any known systemic diseases, other than type II diabetes Mellitus

2. Subjects who have undergone periodontal treatment in previous 6 months

3. Smokers, alcoholics

4. Subject with any stated acute or chronic infection ( including other than periodontitis infection source in oral cavity.

5. Pregnancy, lactating mothers, subjects with gestational diabetes.

Study & Design

Study Type
Observational
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
To estimate left ventricular mass in patients with gingivitis and chronic periodontitis associated with type II Diabetes Mellitus with 15 subjects in each group.Timepoint: It is a cross-sectional trial so patients will be assessed only at baseline and there are no follow up.
Secondary Outcome Measures
NameTimeMethod
secondary outcomes for the current clinical trial are not applicable since it is a cross-sectional study in which patients will be evaluated at baseline. there is no follow-up observation which is mandated according to study design. this study will provide additional information on the severe consequences of lesser known chronic infections such as chronic periodontitis.Timepoint: since there is no follow-up in this trial the time points will only be at baseline.
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