Periodontal DiseasesPhase 1/2NCT04788979
The Adjunctive Use of Melatonin Therapy in the Treatment of Obese Periodontitis Patients (Clinical and Immunological Study).
A Phase 1/2 study testing Melatonin 5Mg Oral Tablet in people with Periodontal Diseases, run by University of Baghdad at 1 site in Iraq.
Trial summary
To evaluate the effect of adjunctive systemic administration of melatonin to mechanical non- surgical periodontal therapy in obese patients with periodontitis. Read more about this study
- Who is it for?
- Ages 27 to 54 years
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- Melatonin 5Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- 1 siteIraq
- Study dates
- 1 Apr 2021to Feb 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 27 to 54 years
- All sexes
- No healthy volunteers
- Adult
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.
-
Trial locations and contacts
1 site in 1 country.
Maha Shukri, Prof contact
About this study
Official title: The Adjunctive Use of Systemic Melatonin Therapy in the Treatment of Periodontitis Associated With Obesity (Clinical and Immunological Study).
To evaluate the effect of adjunctive systemic administration of melatonin to mechanical non- surgical periodontal therapy in obese patients with periodontitis.
Read the 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.
- Conditions
- Periodontal Diseases
- Being tested
- Melatonin 5Mg Oral Tablet
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 5Mg Oral TabletDrug
- 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)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
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
Measured: 4 weeks
Secondary outcomes (2)
measurement of lipid profiles in serum
cholesterol, triglycerides,HDL,LDL
Measured: 4 weeks
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).
Measured: base line visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion20 Dec 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sami Hussam, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788979
- Sponsor's protocol ID
- melatonin and periodontitis
- Status last verified
- Mar 2021
- First submitted
- 28 Feb 2021
- Last updated
- 9 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 21029156Andersen 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.
PubMed 24318695
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Adjunctive Use of Systemic Melatonin Therapy in the Treatment of Periodontitis Associated With Obesity (Clinical and Immunological Study).
- ClinicalTrials.gov ID
- NCT04788979
- Acronym / sponsor ID
- melatonin and periodontitis
- Conditions
- Periodontal Diseases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 20 Dec 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- 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
Who may qualify
- Ages
- 27 to 54 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Melatonin 5Mg Oral Tablet1. 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) | Drug | – |
Primary outcome
measurement of clinical periodontal parameters
Time frame: 4 weeks
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.
measurement of biochemical markers in serum
Time frame: 4 weeks
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
2 secondary outcomes
measurement of lipid profiles in serum
Time frame: 4 weeks
measurement of BMI
Time frame: base line visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Background: PubMed 21029156Gitto 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.
- Background: PubMed 24318695Andersen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maha Shukri, Prof contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Melatonin 5Mg Oral Tablet in people with Periodontal Diseases, run by University of Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hussam sami, DR (07801350374, husamdentist.1991@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurement of clinical periodontal parameters (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04788979, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.