The main purpose of this study is evaluating the effectiveness of adjunctive Subantimicrobial Dose Doxycycline on phase I of periodontal therapy. The study is randomized, placebo controlled, double blind, single- center. Forty patients with chronic periodontitis with at least 14 teeth, 8 pocket with PD ≥ 5 mm and CAL ≥ 4 mm, no systemic disease or hyper sensitivity to any antibiotic from tetracycline family, no usage of antibiotic or any other drugs and periodontal therapy in 4 last months, no usage of alcohol or smoking and no pregnant and lactation, would be selected. The test group receives SRP and SDD (doxycycline, 20 mg b.i.d) but the control group receives SRP and Placebo (like starch) for three months. The expected result is improvement of clinical parameter in periodontal disease.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203229321N1
Registration date:2012-04-11, 1391/01/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-04-11, 1391/01/23
Registrant information
Name
Farzane-al-sadat Vaziri
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 35 1621 4257
Email address
ahmad.haerian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2011-12-07, 1390/09/16
Expected recruitment end date
2012-01-09, 1390/10/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of adjunctive Subantimicrobial Dose Doxycycline on phase I of periodontal therapy
Public title
Effectiveness of 20 mg Doxycycline on periodontal therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients with at least 14 teeth, 8 pocket with PD ≥5 mm and CAL ≥4 mm. Exclusion criteria: patients with systemic disease or hyper sensitivity to any antibiotic from tetracycline family; usage of antibiotic or any other drugs and periodontal therapy in 4 last months; usage of alcohol or smoking; pregnancy and lactation.
Age
From 26 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
Yazd Shahid Sadoughi University of Medical Sciences
Street address
Bulding number 2, bahonar Square
City
Yazd
Postal code
Approval date
2011-07-23, 1390/05/01
Ethics committee reference number
17/1/50351/پ
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
Pocket depth
Timepoint
Base line, 3 and 6 months later
Method of measurement
Williams probe (mm)
2
Description
Clinical attachment loss
Timepoint
Base line, 3 and 6 months later
Method of measurement
Williams probe (mm)
3
Description
Bleeding on probing
Timepoint
Base line, 3 and 6 months later
Method of measurement
Williams probe (mm)
Secondary outcomes
empty
Intervention groups
1
Description
Scaling and 20 mg Doxycycline b.i.d for 3 months.
Category
Treatment - Drugs
2
Description
Scaling and placebo (starch, 20mg, b.id) for 3 months.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Sciences and Health Services
Full name of responsible person
Dr Mir-Mohammadi
Street address
Building number 2, Bahonar square
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Sciences and Health Services
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
Dental School, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Dr. Ahmad Haerian
Position
PHD
Other areas of specialty/work
Street address
Dental School, Shahid Sadoughi University of Medical Sciences, Dahe Fajr blvd
City
Yazd
Postal code
Phone
+98 36 1621 4257
Fax
Email
ahmad.haerian@ssu.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental School, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Farzanealsadat Vaziri
Position
Post graduate of periodontology
Other areas of specialty/work
Street address
Dental School, Shahid Sadoughi University of Medical Sciences, Dahe Fajr blvd
City
Yazd
Postal code
Phone
+98 35 1621 4257
Fax
Email
farzane.vaziri@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental School, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Farzanealsadat Vaziri
Position
Post graduate of periodontology
Other areas of specialty/work
Street address
Dental School, Shahid Sadoughi University of Medical Sciences, Dahe fajr blvd
City
Yazd
Postal code
Phone
+98 35 1621 4257
Fax
Email
farzane.vaziri@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)