1. Determination and comparison of serum ferritin in patients with periodontitis before intervention after non-surgical periodontitis treatment and after non-surgical periodontitis treatment with administration of melatonin system
2. Determination and comparison of periodontal clinical parameters before and after the intervention in two case control groups.
Design
The randomized double-blinded clinical trial
Settings and conduct
42 patients with moderate periodontitis referred to Tabriz Dental School are selected and periodontal parameters will be recorded and a blood sample will be taken. After SRP, all patients will receive mouthwash and will be randomly divided into 2 groups. In the intervention group, chlorohexidine mouthwash and oral administration of melatonin tablets will be given for 30 days and in the control group, chlorhexidine will be administered. After 30 days and three months, blood samples will be taken to determine serum ferritin levels.
Participants/Inclusion and exclusion criteria
En Entry criteria: 1.Lake of loss the joints in interdental areas larger than 4 mm. 2.Absent depth of the envelope larger than 4 mm in the interdental areas. The bleeding tendency is less or equal to 10% in total
Exit criteria:1.People with systemic disorders 2. Invader Periodontium 3. Smokers and Alcoholics 4. Pregnancy or breastfeeding 5. Patients taking medications that can affect the level of melatonin 6. Those who have had periodontal treatment in the last 6 months. 7.People working in night shifts. 8.Under-20s. 9.People with mental disabilities
Intervention groups
In the intervention group (21 patients), chlorohexidine was administered 12% twice daily for 30 seconds for two weeks. And taking oral melatonin 3 mg daily for one day for 30 days
Main outcome variables
ferritin levels
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100412003690N9
Registration date:2018-12-08, 1397/09/17
Registration timing:retrospective
Last update:2018-12-08, 1397/09/17
Update count:0
Registration date
2018-12-08, 1397/09/17
Registrant information
Name
Masoomeh Faramarzie
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1385 4863
Email address
faramarzim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-26, 1397/09/05
Expected recruitment end date
2018-12-01, 1397/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of systemic melatonin and non surgical periodontal therapy on serum ferritin inpatients with periodontitis disease
Public title
Effects of systemic melatonin and non surgical periodontal therapy on serum ferritin inpatients with periodontitis disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
1. Lake of loss the joints in interdental areas larger than 4 mm.
2.Absent depth of the envelope larger than 4 mm in the interdental areas.
3. The bleeding tendency is less or equal to 10% in total.
4. Age older than twenty years
Exclusion criteria:
1. People with systemic disorders, such as epilepsy, schizophrenia, chronic infections, neoplastic disease, or any disease that affects the immune system.
2.Invader Periodontium
3. Smokers and Alcoholics
4. Pregnancy or breastfeeding
5. Patients taking medications that can affect the level of melatonin
6. Those who have had periodontal treatment in the last 6 months.
7.People working in night shifts.
8.Under-20years.
9.People with mental disabilities
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
42
Randomization (investigator's opinion)
Randomized
Randomization description
Referring patients with periodontitis to Tabriz Faculty Of Dentistry are numbered, after observing the entry and exit requirements of the study. Then, using a random number table, we select 42 numbers from this table and enter the subject.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the participating patients and physician will be informed of the type of treatment intervention (1-Chlorhexidine mouthwash 2- Melatonin oral administration), however, the evaluator of the results will not be aware of the intervention method, so the study will be single-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166615953
Approval date
2018-11-19, 1397/08/28
Ethics committee reference number
IR.TBZMED.REC.1397.664
Health conditions studied
1
Description of health condition studied
Periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
serum ferritin level
Timepoint
Before the start, One and three months later
Method of measurement
Blood sampling
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:The Vi-One chlorohexidine 2%mouthwash will be used for one minute to wash teeth in the morning and at night, and oral melatonin tablets will be taken for a period of 30 days once a day before bedtime.
Category
Treatment - Drugs
2
Description
Control group: Chlorhexidine mouthwash for 30 days
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht Ave, Tabriz, IRAN
Full name of responsible person
Masoumeh Faramarzi
Street address
Golgasht Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
faramarzim@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolgasem Jouyban
Street address
Golgasht Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
faramarzim@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoomeh Faramarzie
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golgasht Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
faramarzim@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoomeh Faramarzie
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golgasht Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
faramarzim@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoomeh Faramarzi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golgasht Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
faramarzim@tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data obtained from the participants can be presented in the form of a table. The protocol for the study, which is routine methods, has no problems with its publication. Statistical analysis can also be provided. In this study, an informed consent form will be used that can be published without mentioning the person's name and personal details. A clinical study report can be made after the necessary analyzes.
When the data will become available and for how long
Start the access period 9 months after publishing the results
To whom data/document is available
For researchers in Dental school of Tabriz University
Under which criteria data/document could be used
For scholars working in other academic and academic institutions, if approved by the project implementer
From where data/document is obtainable
Dr. Masoomeh Faramarzi, email or phone Dental school of Tabriz University, Periodontics department, 9144113420 0098 ، faramarzim@tbzmed.ac.ir
What processes are involved for a request to access data/document
After receiving the request will be answered within a week.