The effect of melatonin supplementation in the treatment of type 2 diabetic patients with chronic periodontitis disorder.

The effect of melatonin supplement along with non surgical periodontal therapy on periodontal status, salivary melatonin, glycemic control, inflammatory markers and blood lipid profile in type 2 diabetic patients with chronic periodontitis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017011631993N1

Enrollment

Registered

2017-02-12

Start date

2017-01-29

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

Type 2 diabetes. Non-insulin-dependent diabetes mellitus

Interventions

Intervention 1: Intervention group: The intervention group receives two 3-mg Melatonin tablets per day, 1 hour before bedtime, for 60 days. Intervention 2: The control group receives two 3-mg placebo

Placebo

Intervention group: The intervention group receives two 3-mg Melatonin tablets per day, 1 hour before bedtime, for 60 days.

The control group receives two 3-mg placebo tablets (containing cellulose, silicon dioxide and starch) per day, 1 hour before bedtime, for 60 days.

Eligibility

Sex/Gender

All

Age

30 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Males and females aged 30 – 60 y; type 2 diabetic patients who have been suffering from the disease for at least 5 years and have chronic periodontal disease; BMI = 18.5 and < 30kg/m2. Exclusion criteria: diabetic patients being under insulin therapy; pregnancy; breast feeding ; history of periodontal treatment;

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
IL-6. Timepoint: Before and after the intervention. Method of measurement: ELISA.;Fasting blood sugar. Timepoint: Before and after the intervention. Method of measurement: Using enzymatic kit method.;Hs-CRP. Timepoint: Before and after the intervention. Method of measurement: ELISA.;HbA1C. Timepoint: Before and after the intervention. Method of measurement: Using enzymatic kit method.;HDL.C. Timepoint: Before and after the intervention. Method of measurement: Using enzymatic kit method.;Triglyceride. Timepoint: Before and after the intervention. Method of measurement: Using enzymatic kit method.;LDL.C. Timepoint: Before and after the intervention. Method of measurement: Using enzymatic kit method.;Total cholestrol. Timepoint: Before and after the intervention. Method of measurement: Using enzymatic kit method.;Salivary malatonin. Timepoint: Before and after the intervention. Method of measurement: ELISA.;Bleeding during probe. Timepoint: Before and after the intervention. Method of measurement: Evaluation of bleeding.;Plaque index. Timepoint: Before and after the intervention. Method of measurement: Plaque is on the tooth surface.;Pocket dept. Timepoint: Before and after the intervention. Method of measurement: The probing depth is measured by the probe.;Clinical attachment level. Timepoint: Before and after the intervention. Method of measurement: Depth study of cement and enamel plaque periodontal.	—

Measure

Time frame

IL-6. Timepoint: Before and after the intervention. Method of measurement: ELISA.;Fasting blood sugar. Timepoint: Before and after the intervention. Method of measurement: Using enzymatic kit method.;Hs-CRP. Timepoint: Before and after the intervention. Method of measurement: ELISA.;HbA1C. Timepoint: Before and after the intervention. Method of measurement: Using enzymatic kit method.;HDL.C. Timepoint: Before and after the intervention. Method of measurement: Using enzymatic kit method.;Triglyceride. Timepoint: Before and after the intervention. Method of measurement: Using enzymatic kit method.;LDL.C. Timepoint: Before and after the intervention. Method of measurement: Using enzymatic kit method.;Total cholestrol. Timepoint: Before and after the intervention. Method of measurement: Using enzymatic kit method.;Salivary malatonin. Timepoint: Before and after the intervention. Method of measurement: ELISA.;Bleeding during probe. Timepoint: Before and after the intervention. Method of measurement: Evaluation of bleeding.;Plaque index. Timepoint: Before and after the intervention. Method of measurement: Plaque is on the tooth surface.;Pocket dept. Timepoint: Before and after the intervention. Method of measurement: The probing depth is measured by the probe.;Clinical attachment level. Timepoint: Before and after the intervention. Method of measurement: Depth study of cement and enamel plaque periodontal.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHadi Bazyar

Ahvaz Jundishapur University of Medical Sciences

hadibazyar2015@gmail.com+98 74 3333 1257

Outcome results

None listed

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