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

NCT ID: NCT06199440

Last Updated: 2024-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-03-30

Brief Summary

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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

Detailed Description

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Conditions

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Periodontal Diseases Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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Group I

Chronic periodontitis patients with diabetes mellitus type II who received scaling and root planning.

Group Type ACTIVE_COMPARATOR

Group I

Intervention Type DRUG

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

Group II

Received azithromycin dosage is 250 mg/day for 5 days, after an initial dose of 500 mg one hour before NSPT

Group Type EXPERIMENTAL

Group II

Intervention Type 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

Consisted of 5 type 2 Diabetes Mellitus patients with periodontitis who were received doxycycline 20mg twice/day.

Group Type EXPERIMENTAL

Group III

Intervention Type 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.

Interventions

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Group I

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

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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

\-
Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Abdulaziz University

OTHER

Sponsor Role lead

Responsible Party

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Jazia Alblowi

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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King Abdulaziz University

Jeddah, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

Other Identifiers

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121-06-23

Identifier Type: -

Identifier Source: org_study_id

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