Effect of low dose Doxycycline as an adjuct to non-surgical periodontal therapy on the serum level of inflammatory mediators and lipid profile in advanced periodontitis
The aim of this study is to evaluate the effect of periodontal treatment with or without low dose Doxycycline on circulating TNF – α, IL – 6, and serum Lipids in advanced periodontitis. Thirty four participants, aged 40-70 year-old, with severe generalized periodontitis are recruited from patients referred to the periodontics department, faculty of Dentistry, Guilan University of Medical Sciences. The patients are randomly assigned into control or intervention group to receive deep scaling and root planing, chlorhexidine mouthwash, and oral hygiene instruction as well as either placebo or 40 mg doxycycline capsule for one month. Serum level of inflammatory mediators as well as periodontal parameters including probing pocket depth, clinical attachment level, bleeding upon probing, and plaque index are measured (by a blind examiner) before and one month after the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904071081N4
Registration date:2010-10-28, 1389/08/06
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-10-28, 1389/08/06
Registrant information
Name
Golpar Radafshar
Name of organization / entity
Guilan University of Medical Sciences, School of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 13 1323 0775
Email address
golshad@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Guilan University of Medical Sciences,
Expected recruitment start date
2010-04-05, 1389/01/16
Expected recruitment end date
2010-06-06, 1389/03/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of low dose Doxycycline as an adjuct to non-surgical periodontal therapy on the serum level of inflammatory mediators and lipid profile in advanced periodontitis
Public title
Effect of low dose Doxycycline as an adjuct to non-surgical periodontal therapy on the serum level of inflammatory mediators and lipid profile in advanced periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 40 to 70 years , Being systemically healthy with no history of Arthritis, GI disorders, skin diseases, bronchitis, Diabetes Mellitus, pregnancy or breast feeding, Body mass index between 20-27, Existence of at least 20 standing teeth without untreated periapical lesions, and at least 15% of sites with more than or equal to 5 mm of clinical attachment loss and evidence of bone loss in at least two quadrants.
Exclusion criteria: Being under treatment with drugs such as: anticoagulants, steroids, anti-inflammatory drugs, immunosuppressant drugs within past 6 months, any periodontal treatment within past three months, heavy smokers
Age
From 40 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice-chancellor for Research
Street address
Building of Guilan University of Medical Sciences, Mellat St., Namjoo Blvd.
City
Rasht
Postal code
Approval date
empty
Ethics committee reference number
40021
Health conditions studied
1
Description of health condition studied
advanced periodontitis disease
ICD-10 code
K05.3
ICD-10 code description
Chronic Periodontitis
Primary outcomes
1
Description
Serum inflammatory mediator: TNF-α
Timepoint
Baseline and one month after the intervention
Method of measurement
Laboratory test: ELIZA
2
Description
Serum inflammatory mediator: IL-6
Timepoint
Baseline and one month after the intervention
Method of measurement
Laboratory test: ELIZA
3
Description
Serum cholesterol levels
Timepoint
Baseline and one month after the intervention
Method of measurement
Routine laboratory tests
4
Description
Serum level of LDL
Timepoint
Baseline and one month after the intervention
Method of measurement
Routine laboratory tests
5
Description
Serum level of HLDL
Timepoint
Baseline and one month after the intervention
Method of measurement
Routine laboratory tests
6
Description
Serum triglyceride levels
Timepoint
Baseline and one month after the intervention
Method of measurement
Routine laboratory tests
Secondary outcomes
1
Description
periodontal parameter: Probing Pocket Depth
Timepoint
Baseline and one month after the intervention
Method of measurement
Calibrated periodontal probe
2
Description
Periodontal parameter: Clinical Attachment Level
Timepoint
Baseline and one month after the intervention
Method of measurement
Calibrated periodontal probe
3
Description
Periodontal parameter: Bleeding on probing
Timepoint
Baseline and one month after the intervention
Method of measurement
Bleeding points index ( Lenox & Kopczyk)
4
Description
Dental Plaque
Timepoint
Baseline and one month after the intervention
Method of measurement
Oleary plaque index
Intervention groups
1
Description
Doxycycline one 40mg capsule per day plus intensive scaling and root planing
Category
Treatment - Drugs
2
Description
One placebo capsule per day plus intensive scaling and root planing
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Periodontology,School of dentistry,Guilan University of Medical Sciences
Full name of responsible person
Golpar Radafshar
Street address
Opp. Pardis Hotel, Emam Khomeini Blvd.
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research, Guilan University of Medical Sciences
Full name of responsible person
Susan Komaie
Street address
Building of Guilan University of Medical Sciences, Mellat St., Namjoo Blvd.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research, Guilan 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
Department of Periodontology, Dental Research Center, School of Dentistry, Guilan University of Medi
Full name of responsible person
Nastaran Mirfarhadi
Position
MS in Nursing Education/Director of Dental Research Center
Other areas of specialty/work
Street address
Opp. Pardis Hotel, Emam Khomeini Blvd.
City
Rasht
Postal code
41887-94755
Phone
+98 13 1323 0787
Fax
+98 13 1323 0787
Email
nargol_farahani@yahoo.com
Web page address
www.gums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Periodontology, Dental Research Center, School of Dentistry, Guilan University of Medi
Full name of responsible person
Golpar Radafshar
Position
Head of Dental Research Center/Assistant Professor
Other areas of specialty/work
Street address
Opp. Pardis Hotel, Emam KHomeini Blvd.
City
Rasht
Postal code
41887-944755
Phone
00981313230787-01313220060
Fax
00981313230787-01317757636
Email
golshad@gums.ac.ir
Web page address
www.gums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Department of Periodontology, Dental Research Center, School of Dentistry, Guilan University of Medi
Full name of responsible person
Golpar Radafshar
Position
Head of Dental Research Center/ Assistant Professor
Other areas of specialty/work
Street address
Opp. Pardis Hotel, Emama khomeini Blvd.
City
Rasht
Postal code
41887-94755
Phone
+98 13 1323 0775
Fax
00981317757636-01313230878
Email
golshad@gums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)