The Adjunctive Use of Melatonin Therapy in the Treatment of Obese Periodontitis Patients (Clinical and Immunological Study).

NCT04788979 | Unknown Phase 1

• 1 other identifier: melatonin and periodontitis
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect of adjunctive systemic administration of melatonin to mechanical non- surgical periodontal therapy in obese patients with periodontitis.

Conditions

Periodontal Diseases

Outcome Measures

Primary Outcomes (2)

• measurement of clinical periodontal parameters

  1. plaque index 2. gingival index 3. bleeding on probing 4. pocket depth 5. relative attachment level all parameters are recorded by using periodontal probe.

  4 weeks

• measurement of biochemical markers in serum

  1. measurement of receptor activator of nuclear KB receptor 2. measurement of total antioxidant capacity 3. measurement of melatonin level all markers are recorded by using Eliza

  4 weeks

Secondary Outcomes (2)

• measurement of lipid profiles in serum

  4 weeks

• measurement of BMI

  base line visit

Interventions

Melatonin 5Mg Oral Tablet DRUG

1. control without treatment 2. obese periodontitis patients treated only by scaling and root planning 3. obese periodontitis patients treated with scaling and root planning with daily dietary supplementation of 5 mg melatonin (NOW-USA)

Eligibility Criteria

• Age: 27 Years - 54 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The second one is experimental group which must have the following criteria:
• latest sleep, obese patients diagnosed to have periodontitis with probing pocket depth ≥ 5mm, 2-patients able to follow the required instruction.

You may not qualify if:

• patient taking anti-inflammatory drugs, antibiotics, immunosuppressant or oral contraceptives since last 3 months.
• paients with diabetic mellitus, liver diseases, autoimmune diseases and osteoporosis.
• pregnant or lactating women. 6-cancer patient. 7-smoker patient.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

university of Baghdad

Baghdad, Iraq

Location

Related Publications (2)

• Gitto E, Aversa S, Reiter RJ, Barberi I, Pellegrino S. Update on the use of melatonin in pediatrics. J Pineal Res. 2011 Jan;50(1):21-8. doi: 10.1111/j.1600-079X.2010.00814.x. Epub 2010 Oct 1.

  PMID: 21029156 BACKGROUND

• Andersen LP, Rosenberg J, Gogenur I. Perioperative melatonin: not ready for prime time. Br J Anaesth. 2014 Jan;112(1):7-8. doi: 10.1093/bja/aet332. No abstract available.

  PMID: 24318695 BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Melatonin; Tablets

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Hussam sami, DR

CONTACT

07801350374; husamdentist.1991@gmail.com

Maha Shukri, Prof

CONTACT

07716249206

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: self investigator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: The subjects included in the study were the following: 1-control group:20 subjects (healthy) 2-30 obese periodontitis patients.dont take melatonin 3-30 obese periodontitis patients taking melatonin

Study Record Dates

• First Submitted: February 28, 2021
• First Posted: March 9, 2021
• Study Start: April 1, 2021
• Primary Completion: December 20, 2021
• Study Completion: February 1, 2022
• Last Updated: March 9, 2021

Record last verified: 2021-03

Locations

IR (1)