Periodontitis is a chronic inflammatory infection in which tissue destruction is associated with an imbalance between oxidant _antioxidant systems. Melatonin is a biomarker that has an antioxidant action. Non-surgical treatment is one periodontal treatment method that affects etiologic factors.The aim of this study is investigated salivary melatonin concentration and its changes following non-surgical treatment in periodontal disease.
Inclusion criteria is patient with severe periodontitis،moderate periodontitis،gingivitis and healthy subjects.Patients with systemic disease will be excluded.Study groups include 45 patients with periodontal disease and 15 healthy subjects selected as controls. Intervention include scalling and root planing.Unstimulated saliva was collected before and after scaling and root planing.Decrease inflamation is expected.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013050613239N1
Registration date:2013-09-21, 1392/06/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-09-21, 1392/06/30
Registrant information
Name
Fatemeh Mohammadi
Name of organization / entity
Ahvaz Jondishapoor University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 61 1559 3207
Email address
mohammadi.f@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research and Technology Development Department of Medical Sciences, Ahvaz
Expected recruitment start date
2013-09-16, 1392/06/25
Expected recruitment end date
2014-02-24, 1392/12/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of scaling and root planing effects on salivary melatonin level in
patients with chronic periodontitis
Public title
Effect of scaling and root planing on salivary melatonin level
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusin criteria: patients with severe periodontitis؛ patients with moderate periodontitis؛ patients with gingivitis؛ subjects with periodontal healthy.
Exclusion criteria: periodontal treatment or antibiotic therapy within the last 3 months؛ presence of any systemic disease (e.g.,diabetes mellitus, asthma)؛ working in night shifts؛ xerostomia or any other disease of the salivary glands؛ less than 20 teeth؛ intake of any drug known to alter
melatonin levels (e.g., for sleeping disorders) or to be immunosuppressive؛ usage of partial or total prosthesis؛ pregnancy؛ lactation؛ acute infection؛ immunodeficiency؛ history of radio- or chemotherapy؛ and any conditions necessitating antibiotic premedication for dental appointment.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz University of Medical Sciences
Street address
Mehr street, Golestan
City
Ahvaz
Postal code
Approval date
2012-11-19, 1391/08/29
Ethics committee reference number
eth578
Health conditions studied
1
Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
Melatonin
Timepoint
Before intervention
Method of measurement
Concentration
Secondary outcomes
1
Description
Severity of disease
Timepoint
After intervention
Method of measurement
Pocket depth
Intervention groups
1
Description
Scaling and root planning
Category
Treatment - Other
2
Description
No intervention
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Mohammadi
Street address
City
Ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Development Deputy of Avaz University
Full name of responsible person
Dr Mostafa Feghhi
Street address
Medical science university, Mehr street, Goletan
City
Ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Development Deputy of Avaz University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Dr Leila Golpasand
Position
Attend of Periodontal Surgery Department
Other areas of specialty/work
Street address
Ahvaz University of Medical Sciences, Mehr street, Golestan
City
Ahvaz
Postal code
Phone
+98 61 1552 7368
Fax
Email
drleilagolpasand@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Dentistry
Full name of responsible person
Dr Leila Golpasand
Position
Attend of Periodontology Department
Other areas of specialty/work
Street address
Faculty of Dentistry, Ahvaz University of Medical Science, Mehr street, Golestan
City
Ahvaz
Postal code
Phone
+98 61 1552 7368
Fax
Email
drleilagolpasand@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Fatemeh Mohammadi
Position
Resident of Periodontology Department
Other areas of specialty/work
Street address
Plaque 26, Street 31, Padad
City
Ahvaz
Postal code
Phone
+98 61 1559 3207
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)