A randomized double-blind placebo-controlled, clinical trial the effect of non-surgical periodontal therapy plus subgingivally azithromycin gel on HbA1c in patients with type 2 diabetes mellitus (DM).

The effect of non-surgical periodontal therapy plus azithromycin gel on HbA1c in patients with type 2 diabetes mellitus (DM).

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2015010517587N9

Enrollment

Registered

2015-02-18

Start date

2014-11-21

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

periodontitis. Periodontitis

Interventions

Intervention 1: "Intervention group": Azithromycin 2.5 mg gel was manufactured by khakpour Pharmaceutical Laboratory,Tehran- Iran . Intervention 2: "Control group":Placebo of was prepared in the same

Treatment - Drugs

"Intervention group": Azithromycin 2.5 mg gel was manufactured by khakpour Pharmaceutical Laboratory,Tehran- Iran .

"Control group":Placebo of was prepared in the same manner but without the active drug in it (Made by the khakpour Pharmaceutical,Tehran-Iran)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: "Inclusion criteria": patients with diabetes mellitus type II (at least 3 months before diagnosis, and A fasting blood sugar level of more than 125 mg/dl) and has periodontal disease is a chronic moderate (has a clinical attachment level of 3-4 mm) peritonitis, minimum of 16 natural teeth, and no periodontal treatment in the prior 6 months, had an glycated a hemoglobin (HbA1c) value between 7- 9 percent at screening, had reported no changes in diabetes medications within the last 3 months, were in the care of a physician for their diabetes. "Exclusion criteria": pregnancy or lactation, history of allergy to drugs used in the study; smoking; diabetes related emergency within 30 days ago; use of nonsteroidal anti-inflammatory drugs; or taking low dose daily aspirin (75-325 mg); use of immunosuppressive medications; antibiotic use; dialysis; risk of bleeding complications; the type of disease periodontal (Aggressive); a history of periodontal treatment in the previous 6 months; orthodontic treatment; using the removal prostheses; extensive dental caries; dental abscesses or infections.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Periodontal pocket. Timepoint: 15 days. Method of measurement: Periodontal probe.	—

Secondary

Measure	Time frame
Glycated hemoglobin (HbA1c). Timepoint: 3 months. Method of measurement: Blood test.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmirhossein Farahmand

Dental Branch Islamic Azad University of Tehran

perio-implant@hotmail.com+98 21 2284 9604

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026