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Completed

NCT Number: NCT06199440

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

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

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Key information

Conditions

Periodontal Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Stomatognathic Diseases Type 2 Diabetes

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

King Abdulaziz University

Jeddah, Saudi Arabia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Group I

Drug

First group are chronic periodontitis patients with diabetes mellitus type II who received scaling and root planning.

Group II

Drug

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

Drug

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.

Primary outcomes

  1. Primary Outcome

    Time frame: 3 months

    Improvements in clinical parameters of periodontitis including Gingival Index, Probing Depth and Clinical Attachment Level

Secondary outcomes

  1. Secondary Outcome

    Time frame: 3 months

    Improved resistin level

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 10, 2024
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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