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NCT06199440 Clinical Trial

Azithromycin Versus Doxycycline on Restistin Level in Periodontitis Patients With Type 2 Diabetes

Type 2 Diabetes Clinical Trial

Official title:
Azithromycin Versus Doxycycline on Resistin Level in Periodontitis Patients With Type 2 Diabetes. A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06199440
Other study ID # 121-06-23
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date June 1, 2022
Est. completion date March 30, 2023

Study information
Verified date December 2023
Source King Abdulaziz University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate the adjunctive effects of systemic antibiotics used in nonsurgical periodontal treatment (NSPT), compared with NSPT alone, on the periodontal clinical parameters and resistin level in diabetic patients with periodontitis, in order to identify which, one provides an additional effect to non-surgical periodontal therapy

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date March 30, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers No
Gender All
Age group 25 Years to 50 Years
Eligibility Inclusion Criteria: Patients were clinically diagnosed as having at least three site with CAL = 5mm; moderate to advanced chronic periodontitis according to the criteria of American Academy of Periodontology. - Free from any other systemic conditions that affect the periodontium except for Diabetes mellitus type II. - No periodontal therapy, systemic antibiotics or non-steroidal anti-inflammatory agents during the preceding 6 months. - Non-smokers. - Non-pregnant. Exclusion Criteria: -

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Group I
First group are chronic periodontitis patients with diabetes mellitus type II who received scaling and root planning.
• Group II
Second group will receive 250 mg of azithromycin per day for a period of 5 days, after an initial dose of 500 mg one hour before NSPT.
• Group III
Third group are Type 2 DM patients who received doxycycline 20mg twice/day. Gingival crevicular fluid will be collected at 0, 1, and 3 months to assess Serum Resistin using a human Resistin enzyme-linked immunosorbent assay Kit following the manufacturer's protocol.

Locations
Country Name City State
Saudi Arabia King Abdulaziz University Jeddah

Sponsors (1)
Lead Sponsor Collaborator
King Abdulaziz University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Primary Outcome Improvements in clinical parameters of periodontitis including Gingival Index, Probing Depth and Clinical Attachment Level 3 months
Secondary Secondary Outcome Improved resistin level 3 months
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