Aims: Comparing the effect of adjunctive low dose doxycycline with Omega-3 fatty acid and low-dose Aspirin in chronic periodontitis
Study design: Interventional, Double blind, Placebo usage, Uni-center.
a- Study population: With age limit, no sex limit.
Inclusion criteria: chronic mild to moderate periodontitis. Exclusion criteria: Patients with any infectious or systemic diseases; no drug usage at all; pregnant, breast feeder patients; patients allergic to antibiotics; no scaling and root planning or periodontal surgeries in the last six months; no usage of antibiotic drugs during the last six months; Smokers, alcoholics; patients with poor oral hygiene or patients with poor compliance
Sample size:45 patients
b- Intervention/Control:
Intervention: One 20mg Capsule of Doxycycline per day
Intervention: One 400mg Tablet of Omega-3 fatty acid and one 80mg Tablet of Aspirin per day
Control: One Placebo Capsule per day
Time of intervention: 6 weeks.
Primary or under study outcome measures: Clinical pocket depth, Bleeding on probing, Clinical attachment loss
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013022511771N4
Registration date:2013-03-09, 1391/12/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-03-09, 1391/12/19
Registrant information
Name
Shirin Zahra Farhad
Name of organization / entity
Khorasgan Islamic Azad Dental School (Isfahan)
Country
Iran (Islamic Republic of)
Phone
+98 31 1664 1410
Email address
drsh.farhad@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Khorasgan Islamic Azad Dental School
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2012-11-21, 1391/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of adjunctive low dose doxycycline with Omega-3 fatty acid and low-dose Aspirin in chronic periodontitis
Public title
comparison of doxycycline effect with Omega-3 fatty acid and low-dose Aspirin in chronic periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: chronic mild to moderate periodontitis.
Exclusion criteria: Patients with any infectious or systemic diseases; no drug usage at all; pregnant, breast feeder patients; patients allergic to antibiotics; no scaling and root planning or periodontal surgeries in the last six months; no usage of antibiotic drugs during the last six months; Smokers, alcoholics; patients with poor oral hygiene or patients with poor compliance
Age
From 25 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
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
Islamic Azad Dental School Khorasgan Branch, (Isfahan), Iran
Street address
Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay Street, Isfahan, Iran.
City
Isfahan
Postal code
Approval date
2012-01-28, 1390/11/08
Ethics committee reference number
90110808904
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
periodontal pocket depth
Timepoint
0 and 6 weeks
Method of measurement
By means of a periodontal probe per milimeters
2
Description
Bleeding on probing
Timepoint
0 and 6 weeks
Method of measurement
Observational with negative or positive
3
Description
Clinical attachment loss
Timepoint
0 and 6 weeks
Method of measurement
By means of a periodontal probe per milimeters
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: One 20mg Capsule of Doxycycline per day
Category
Treatment - Drugs
2
Description
Intervention: One 400mg Tablet of Omega-3 fatty acid and one 80mg Tablet of Aspirin per day
Category
Treatment - Drugs
3
Description
Control: One Placebo Capsule per day
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorasgan Islamic Azad Dental School (Isfahan)
Full name of responsible person
Shirin Zahra Farhad
Street address
Department of Periodontics, Young Researchers Club, Khorasgan Branch, Islamic Azad Dental School (Isfahan), Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University Khorasgan Branch (Isfahan)
Full name of responsible person
Shirin Zahra Farhad
Street address
Periodontics Department of Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay Street, Isfahan, Iran.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University Khorasgan Branch (Isfahan)
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
Islamic Azad Dental School Khorasgan Branch, (Isfahan), Iran
Full name of responsible person
Shirin Zahra Farhad
Position
Assistant Professor of Periodontics
Other areas of specialty/work
Street address
Periodontic Department of Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay Street, Isfahan, Iran.
City
Isfahan
Postal code
Phone
+98 31 1664 1410
Fax
Email
drsh.farhad@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad Dental School Khorasgan Branch, (Isfahan), Iran
Full name of responsible person
Shirin Zahra Farhad
Position
Assistant Professor of Periodontics
Other areas of specialty/work
Street address
Periodontic Department of Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay Street, Isfahan, Iran.
City
Isfahan
Postal code
Phone
+98 31 1664 1410
Fax
Email
drsh.farhad@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad Dental School Khorasgan Branch, (Isfahan), Iran
Full name of responsible person
Shirin Zahra Farhad
Position
Assistant professor of Periodontics
Other areas of specialty/work
Street address
Periodontic Department of Islamic Azad University Khorasgan (Isfahan) Branch, University Boulevard, Arghavanieh, Eastern Jay Street, Isfahan, Iran.
City
Isfahan
Postal code
Phone
+98 31 1664 1410
Fax
Email
drsh.farhad@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)