Azithromycin Versus Doxycycline on Restistin Level in Periodontitis Patients With Type 2 Diabetes
1 other identifier
interventional
15
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2023
CompletedFirst Submitted
Initial submission to the registry
December 29, 2023
CompletedFirst Posted
Study publicly available on registry
January 10, 2024
CompletedJanuary 10, 2024
December 1, 2023
10 months
December 29, 2023
December 29, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Outcome
Improvements in clinical parameters of periodontitis including Gingival Index, Probing Depth and Clinical Attachment Level
3 months
Secondary Outcomes (1)
Secondary Outcome
3 months
Study Arms (3)
Group I
ACTIVE COMPARATORChronic periodontitis patients with diabetes mellitus type II who received scaling and root planning.
Group II
EXPERIMENTALReceived azithromycin dosage is 250 mg/day for 5 days, after an initial dose of 500 mg one hour before NSPT
Group III
EXPERIMENTALConsisted of 5 type 2 Diabetes Mellitus patients with periodontitis who were received doxycycline 20mg twice/day.
Interventions
First group are chronic periodontitis patients with diabetes mellitus type II who received scaling and root planning.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
King Abdulaziz University
Jeddah, Saudi Arabia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 29, 2023
First Posted
January 10, 2024
Study Start
June 1, 2022
Primary Completion
March 30, 2023
Study Completion
March 30, 2023
Last Updated
January 10, 2024
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share