Estimation of the levels salivary macrophage polarization markers in healthy, gingivitis and periodontitis patients with and without diabetes mellitus;

Not Applicable

Completed

• Conditions: Health Condition 1: K053- Chronic periodontitisHealth Condition 2: E116- Type 2 diabetes mellitus with other specified complications

• Registration Number: CTRI/2021/05/033573
• Lead Sponsor: AKSHAYA J

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-07-21
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 52

Inclusion Criteria

Based on 2017 World Workshop on the Classification of Periodontal and Peri-implant diseases and conditions, co-presented by the American Academy of Periodontology (AAP) and the European Federation of Periodontology (EFP),

Inclusion criteria for Healthy group:

1.Pristine periodontal health:

i. No bleeding on probing.

ii. Normal gingival sulcus depth.

iii. Normal bone heights.

iv. Controlled modifying factors.

v. Controlled predisposing factors.

2.Clinical periodontal health (intact periodontium):

i. No or minimal bleeding on probing.

ii. Normal gingival sulcus depth.

iii. Normal bone heights.

iv. Controlled modifying factors.

v. Controlled predisposing factors.

Inclusion criteria for Gingivitis group:

i.Absence of CAL

ii.PPD < 3mm

iii.BOP present

Inclusion criteria for Stage III/IV Periodontitis:

According to the new classification scheme (Kornman and Tonetti et al, 2018).

1.Stage III:

i.Interdental clinical attachment loss at site of greatest loss >= 5mm.

ii.Radiographic bone loss extending to middle or apical third of root

iii.Tooth loss due to periodontitis <= 4 teeth.

iv.Probing depth >= 6mm.

v.Extent: Greater than 30% of teeth involved (Generalized)

2.Stage IV:

i.Interdental clinical attachment loss at site of greatest loss >= 5mm.

ii.Radiographic bone loss extending to middle or apical third of root

iii.Tooth loss due to periodontitis >= 5 teeth.

iv.Extent: Greater than 30% of teeth involved (Generalized)

Inclusion criteria for Type 2 Diabetes mellitus

1.Patients with HbA1c levels more than 8% will be taken for the study in the groups involving Diabetes. (According to American Diabetes Association guidelines 2018)

Exclusion Criteria

1.Pregnant women

2.Pregnant and lactating women.

3.Habits like tobacco ,smoking

4.Patients with immunodeficiency disorders.

5.Patients with other systemic inflammatory conditions like sepsis, pneumonia, pleural effusion, intra-abdominal infections, inflammatory bowel disorders, inflammatory rheumatoid disorders, chronic kidney disease, cancers, atherosclerosis, COPD, asthma, HIV and hepatitis will be excluded from the study.

6.Patients with systemic diseases like hypertension

7.History of periodontal treatment within the previous 6 months.

8.History of antibiotic therapy in the past 3 months.

9.Subjects who are not willing to participate in the study

Study & Design

• Study Type: Observational
• Study Design: Not specified