The current protocol was aimed to investigate the effect of periodontitis treatment on the disease activity in Systemic Lupus Erythematosus. Patients were randomly allocated into two groups of intervention and control using block allocation method (block size 4). The intervention group depends on the severity of the periodontal disease received oral health education or dental scaling and oral health education or 500 mg amoxicillin and 250 mg metronidazole three times per day for 10 day along with dental scaling and oral health education. In the control group, dental hygiene and refer for treatment was recommended. This study was single blind that person who evaluate disease activity in Systemic Lupus Erythematosus was not aware of patients assigned to groups. Inclusion criteria were as follow: Systemic Lupus Erythematosus disease activity index (SELDAI) equal or greater to 2. Exclusion criteria were considered as: Changes in the patient's treatment schedule by increasing the dose or adding another Immunosuppression drug; periodontitis along with other problems including tooth filling; suffering from Rheumatoid Arthritis, diabetes; smoking; medication that lead gum become greater than normal; gum bleeding; changes in the form of alveolar bone. Disease activity was evaluated using SELDAI that included immunological laboratory findings and clinical manifestations of the disease.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017071610340N17
Registration date:2017-07-24, 1396/05/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-24, 1396/05/02
Registrant information
Name
Mohammad Aryaie
Name of organization / entity
Golestan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 911 277 1798
Email address
aryaie@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Golestan University of Medical Science
Expected recruitment start date
2015-03-21, 1394/01/01
Expected recruitment end date
2017-03-19, 1395/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between periodontal interventions with oral health care on the disease activity in Systemic Lupus Erythematosus
Public title
The effect of dental interventions on the disease activity in Systemic Lupus Erythematosus
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria were as follow: Systemic Lupus Erythematosus disease activity index (SELDAI) equal or greater to 2.
Exclusion criteria were considered as: Changes in the patient's treatment schedule by increasing the dose or adding another Immunosuppression drug; periodontitis along with other problems including tooth filling; suffering from Rheumatoid Arthritis, diabetes; smoking; medication that lead gum become greater than normal; gum bleeding; changes in the form of alveolar bone.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Person who evaluate disease activity in Systemic Lupus Erythematosus was not aware of patients assigned to groups
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Golestan University of Medical Science
Street address
4 Kilometer of Gorgan-sari Road, Falsafi educational campus, Vice Chancellor of Technology and Information, Gorgan
City
Gorgan
Postal code
Approval date
2017-07-02, 1396/04/11
Ethics committee reference number
IR.GOUMS.REC.1396.37
Health conditions studied
1
Description of health condition studied
Systemic lupus erythematosus
ICD-10 code
M32
ICD-10 code description
Systemic lupus erythematosus
Primary outcomes
1
Description
disease activity in Systemic Lupus Erythematosus
Timepoint
Three month after intervention
Method of measurement
blood sample
Secondary outcomes
1
Description
Periodontal Assessment
Timepoint
Three month after intervention
Method of measurement
Physical examination
Intervention groups
1
Description
The intervention group received oral health education
Category
Behavior
2
Description
The intervention received dental scaling and oral health education
Category
Treatment - Other
3
Description
The intervention group received 500 mg amoxicillin and 250 mg metronidazole three times per day for 10 day along with dental scaling and oral health education
Category
Treatment - Other
4
Description
In the control group, dental hygiene and refer for treatment was recommended
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sayyad Shirazi Hospital
Full name of responsible person
Hasan Karimi
Street address
Shahid Sayyad Shirazi Hospital, Shahid Sayyad Shirazi Street, Gorgan City, Golestan Province
City
Gorgan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Golestan University of Medical Sciences
Full name of responsible person
Mohsen Saeedi
Street address
4 Kilometer of Gorgan-Sari Road, Falsafi educational campus, Vice chancellor for research, Gorgan
City
Gorgan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Golestan University of Medical Sciences
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
Golestan University of Medical Science
Full name of responsible person
Hasan Karimi
Position
Internist
Other areas of specialty/work
Street address
4 Kilometer of Gorgan-Sari Road, Falsafi educational campus, Vice chancellor of research, Gorgan
City
Gorgan
Postal code
Phone
+98 17 3242 4377
Fax
Email
hasankarimi_1357@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Golestan University of Medical Science
Full name of responsible person
Hasan Karimi
Position
Internist
Other areas of specialty/work
Street address
4 Kilometer of Gorgan-Sari Road, Falsafi educational campus, Vice chancellor of research, Gorgan
City
Gorgan
Postal code
Phone
+98 17 3242 4377
Fax
Email
hasankarimi_1357@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Golsestan University of Medical Sciences
Full name of responsible person
Mohamma Aryaie
Position
MSc in Epidemiology
Other areas of specialty/work
Street address
4 Kilometer of Gorga-nsari Road, Falsafi educational campus, Vice Chancellor of research, Gorgan
City
Gorgan
Postal code
Phone
+98 17 3242 4377
Fax
Email
aryaiem2009@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)