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

Primary Purpose

Periodontal Diseases

Status
Unknown status
Phase
Phase 1
Locations
Iraq
Study Type
Interventional
Intervention
Melatonin 5Mg Oral Tablet
Sponsored by
University of Baghdad
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontal Diseases

Eligibility Criteria

27 Years - 54 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:The study involve three groups: the first one is control (healthy normal weight group).

The second one is experimental group which must have the following criteria:

1-latest sleep, obese patients diagnosed to have periodontitis with probing pocket depth ≥ 5mm, 2-patients able to follow the required instruction.

-

Exclusion Criteria:1-individuals having night work shifts. 2-patients wearing removable partial dentures and undergoing orthodontic treatment.

3-patient taking anti-inflammatory drugs, antibiotics, immunosuppressant or oral contraceptives since last 3 months.

4-paients with diabetic mellitus, liver diseases, autoimmune diseases and osteoporosis.

5-pregnant or lactating women. 6-cancer patient. 7-smoker patient.

-

Sites / Locations

  • university of Baghdad

Outcomes

Primary Outcome Measures

measurement of clinical periodontal parameters
plaque index gingival index bleeding on probing pocket depth relative attachment level all parameters are recorded by using periodontal probe.
measurement of biochemical markers in serum
measurement of receptor activator of nuclear KB receptor measurement of total antioxidant capacity measurement of melatonin level all markers are recorded by using Eliza

Secondary Outcome Measures

measurement of lipid profiles in serum
cholesterol, triglycerides,HDL,LDL
measurement of BMI
multiple measurements will be aggregated to arrive at one reported value (e.g., weight and height will be combined to report BMI in kg/m^2).

Full Information

First Posted
February 28, 2021
Last Updated
March 4, 2021
Sponsor
University of Baghdad
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1. Study Identification

Unique Protocol Identification Number
NCT04788979
Brief Title
The Adjunctive Use of Melatonin Therapy in the Treatment of Obese Periodontitis Patients (Clinical and Immunological Study).
Official Title
The Adjunctive Use of Systemic Melatonin Therapy in the Treatment of Periodontitis Associated With Obesity (Clinical and Immunological Study).
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Anticipated)
Primary Completion Date
December 20, 2021 (Anticipated)
Study Completion Date
February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To evaluate the effect of adjunctive systemic administration of melatonin to mechanical non- surgical periodontal therapy in obese patients with periodontitis.
Detailed Description
Periodontitis defined as destruction of periodontal tissue caused by specific microorganisms resulting of pocket formation, recession and mobility.Obesity known to increase the host tolerance by influencing the immune and inflammatory mechanisms in a way that inflammatory tissue destruction is predisposed and leave a person at high risk of developing periodontitis.the relationship between periodontitis and obesity has been reported in several epidemiological and experimental studies. Obesity can be a higher trigger of chronic stress , stress and how a person copes with stress has been shown to increase the risk of periodontitis.several studied have shown that preserving of normal weight by maintaining regular physical exercise is linked with a lower incidence of periodontitis. As a matter of truth , overweight and obese individuals are more than twice as likely to have periodontitis compared to normal healthy persons. It has been suggested that obesity decreased the blood flow to periodontal tissue, enabling the development of periodontal disorders. The blood vessels of obese subjects demonstrate a thickening in the inner wall of arteries that reduce the flow of blood into periodontium. The adipocytes produce various active molecules called adipokines involving (TNF- α, IL-6, leptin, adiponectin and others). These compound secrete various molecules of reactive oxygen species (ROS) that lowered antioxidant enzymes activity like (superoxide dismutase, catalase, glutathione and others). Thus modulating the effect of adipokines can lower the pathogenicity of periodontitis by reducing the effect of oxidative stress. Oxidative stress appear to be the main link between obesity and periodontitis and can aggravates pro-inflammatory pathways frequent in both pathologies. Regarding the significance of oxidative stress in pathologies of both periodontitis and obesity, several antioxidants play an amazing role as a preventive and therapeutic measures for both diseases. Multiple studies had a greater evidence toward melatonin which have an active antioxidant properties , which is an indolamine produced mainly by pinealocytes. It has been documented that salivary melatonin were significantly decreased in patients with periodontal disease, indicated that melatonin may act as a biomarker for periodontal diagnosis and can be used as a possible therapeutic agent in various periodontal diseases. It is indicated that adjunctive use of melatonin in combination with non-surgical scaling and root planning for 3 weeks can lead to improvement of clinical periodontal parameters in diabetic patients. It was demonstrated that daily dietary supplementation with 3mg melatonin tablet for 4 weeks along with scaling and root planning significantly reduced the oxidative stress in periodontitis patients. similarly , significant reduction in gingival inflammation when melatonin administrated locally as adjunctive measure to standard periodontal therapy. Melatonin promote bone formation by activating type 1 collagen fibers in osteoblast and enhancing the genetic expression of bone sialoprotein , alkhaline phosphates, osteopontien and osteocalcine and downregulate the RANKL mediated osteoclast formation and activation. It had been reported that circulatory serum level of melatonin significantly reduced in obesity .Supplementation of antioxidants in conjunction with other treatment modalities such as dietary changes, behavioral changes, and drug therapy might be beneficial in treatment of obesity and associated inflammatory states ., as melatonin participated in homeostasis and metabolism of energy through activation of brown adipose tissue and enhance energy expenditure. furthermore, significant reduction in body weight along with adipose tissue deposit when melatonin were administrated in obese subjects was reported in. Multiple studies reported that melatonin significantly increase HDL level and decrease TG and HDL level in addition to increased cholesterol catabolism.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
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
Masking
Investigator
Masking Description
self investigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Melatonin 5Mg Oral Tablet
Intervention Description
control without treatment obese periodontitis patients treated only by scaling and root planning obese periodontitis patients treated with scaling and root planning with daily dietary supplementation of 5 mg melatonin (NOW-USA)
Primary Outcome Measure Information:
Title
measurement of clinical periodontal parameters
Description
plaque index gingival index bleeding on probing pocket depth relative attachment level all parameters are recorded by using periodontal probe.
Time Frame
4 weeks
Title
measurement of biochemical markers in serum
Description
measurement of receptor activator of nuclear KB receptor measurement of total antioxidant capacity measurement of melatonin level all markers are recorded by using Eliza
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
measurement of lipid profiles in serum
Description
cholesterol, triglycerides,HDL,LDL
Time Frame
4 weeks
Title
measurement of BMI
Description
multiple measurements will be aggregated to arrive at one reported value (e.g., weight and height will be combined to report BMI in kg/m^2).
Time Frame
base line visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
27 Years
Maximum Age & Unit of Time
54 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:The study involve three groups: the first one is control (healthy normal weight group). The second one is experimental group which must have the following criteria: 1-latest sleep, obese patients diagnosed to have periodontitis with probing pocket depth ≥ 5mm, 2-patients able to follow the required instruction. - Exclusion Criteria:1-individuals having night work shifts. 2-patients wearing removable partial dentures and undergoing orthodontic treatment. 3-patient taking anti-inflammatory drugs, antibiotics, immunosuppressant or oral contraceptives since last 3 months. 4-paients with diabetic mellitus, liver diseases, autoimmune diseases and osteoporosis. 5-pregnant or lactating women. 6-cancer patient. 7-smoker patient. -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hussam sami, DR
Phone
07801350374
Email
husamdentist.1991@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Maha Shukri, Prof
Phone
07716249206
Facility Information:
Facility Name
university of Baghdad
City
Baghdad
Country
Iraq

12. IPD Sharing Statement

Citations:
PubMed Identifier
21029156
Citation
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.
Results Reference
background
PubMed Identifier
24318695
Citation
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.
Results Reference
background

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

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