The effect of melatonin supplementation in the treatment of type 2 diabetic patients

Effect of Melatonin supplement with Non surgical periodontal therapy on periodontal status, some inflammatory markers and serum antioxidant status in type 2 diabetic patients with chronic periodontitis.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT2017030831993N4

Enrollment

Registered

2017-06-01

Start date

2017-05-27

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
Plaque index. Timepoint: Before and after the intervention. Method of measurement: Plaque is on the tooth surface.;TNF-a. Timepoint: Before and after the intervention. Method of measurement: ELISA.;IL-1b. Timepoint: Before and after the intervention. Method of measurement: ELISA.;Total antioxidant capacity (TAC). Timepoint: Before and after the intervention. Method of measurement: ELISA.;Malondialdehyde (MDA). Timepoint: Before and after the intervention. Method of measurement: ELISA.;Activity of superoxide dismutase enzyme (SOD). Timepoint: Before and after the intervention. Method of measurement: ELISA.;Activity of Glutathione peroxidase enzyme (GSHPx). Timepoint: Before and after the intervention. Method of measurement: ELISA.;Activity of Catalase enzyme (GSHPx). 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.;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

Plaque index. Timepoint: Before and after the intervention. Method of measurement: Plaque is on the tooth surface.;TNF-a. Timepoint: Before and after the intervention. Method of measurement: ELISA.;IL-1b. Timepoint: Before and after the intervention. Method of measurement: ELISA.;Total antioxidant capacity (TAC). Timepoint: Before and after the intervention. Method of measurement: ELISA.;Malondialdehyde (MDA). Timepoint: Before and after the intervention. Method of measurement: ELISA.;Activity of superoxide dismutase enzyme (SOD). Timepoint: Before and after the intervention. Method of measurement: ELISA.;Activity of Glutathione peroxidase enzyme (GSHPx). Timepoint: Before and after the intervention. Method of measurement: ELISA.;Activity of Catalase enzyme (GSHPx). 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.;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