Objectives: Evaluating the effect of sub-antimicrobial dose Doxycycline as an adjuvant on periodontal treatments in diabetics and non diabetics
Design: A non- randomized clinical trial, Study sample: 32 patients consist of 16 diabetic and 16 non diabetics.
Inclusion criteria: Patients have at least 14 teeth, at least 8 pockets with PD (Probing Depth)≥5 mm and CAL (Clinical Attachment Level)≥ 4 mm, do not be sensitive to Doxycycline family, do not use interfering drugs with Tetracycline (Anti Coagulants and Oral Contraceptives) and do not have antibiotic therapy or periodontal therapy in 4 months ago.
Intervention: The probing depth, clinical attachment level and bleeding on probing are recorded for diabetic and non diabetic patients. Following Scaling and root planning, patients are divided into intervention and control groups. Doxycycline 20 mg bid (every 12 hours) is prescribed for interventional groups of diabetic and non diabetic patients for 3 months.
Main outcome: All clinical measurements (PD, CAL and BOP) are recorded again after 3 months.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013032212847N1
Registration date:2013-05-29, 1392/03/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-29, 1392/03/08
Registrant information
Name
Arezoo Khabazian
Name of organization / entity
Shahid Sadoghi University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 35 1822 8852
Email address
arezookhabazian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
1- Doxycycline 20 mg from Dr Vahidi Draugstore 2- Other costs will pay by Shahid Sadoghi University of Medical Science, Yazd Dental School
Expected recruitment start date
2013-01-07, 1391/10/18
Expected recruitment end date
2013-05-05, 1392/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of sub-antimicrobial dose Doxycycline as an adjuvant on periodontal treatments in diabetics and non diabetics
Public title
The effect of Doxycycline on periodontal treatment in diabetics and non diabetics
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria include: Patients have at least 14 teeth, at least 8 pockets with PD (Probing Depth)≥5 mm and CAL (Clinical Attachment Level)≥ 4 mm، do not be sensitive to Doxycycline family, do not use interfering drugs with Tetracycline (Anti Coagulants and Oral Contraceptives) and do not have antibiotic therapy or periodontal therapy in 4 months ago.
Age
From 30 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Indeed, this study is in the form of two Clinical Trial Studies, which are concurrently done in order to evaluate the effect of Doxycycline 20 mg on periodontal treatment of diabetic and non diabetic patients. Diabetic and non diabetic patients were randomly divided into two interventional and control groups, even numbers added to intervention group and odd numbers added to control group. The intervention in this study is Doxycycline capsules as scaling and root planning is done for all patients.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Sadoghi University of Medical Science-Yazd Dental School
Street address
Yazd- Fazaye Sabz Square
City
Yazd
Postal code
Approval date
2013-01-06, 1391/10/17
Ethics committee reference number
171142160p
Health conditions studied
1
Description of health condition studied
Moderate to Severe Chronic Periodontitis
ICD-10 code
k05.3, E10
ICD-10 code description
Chronic Periodontitis, Diabetes Mellitus
Primary outcomes
1
Description
Probing depth
Timepoint
Before intervention and 3 months after intervention
Method of measurement
On millimeter scale and by William’s probe
2
Description
Clinical attachment level
Timepoint
Before intervention and 3 months after intervention
Method of measurement
On millimeter scale and by William’s probe
3
Description
Bleeding on probing
Timepoint
Before intervention and 3 months after intervention
Method of measurement
According to percentage of areas which have bleeding
Secondary outcomes
empty
Intervention groups
1
Description
Scaling and root planning is done by an ultrasonic device (China, Woodpecker) for diabetic patients in interventional group 1, then oral Doxycycline 20 mg which was made by a drugstore as much as need for this study is prescribed bid (every 12 hours( for 3 months. It is available in capsules by dose of 100 mg in Iran, but by mixing the content of 100 mg capsules with the starch doses of 20 mg has been identified.
Category
Treatment - Drugs
2
Description
Scaling and root planning is done by an ultrasonic device (China, Woodpecker) for diabetic patients in interventional group 2.
Category
Treatment - Other
3
Description
Scaling and root planning is done by an ultrasonic device (China, Woodpecker) for non diabetic patients in interventional group 3, then Doxycycline 20 mg which was made by a drugstore is prescribed bid for 3 months.
Category
Treatment - Drugs
4
Description
Scaling and root planning is done by an ultrasonic device (China, Woodpecker) for non diabetic patients in interventional group 4.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Diabetes Research Center- Shahid Sadoghi University of Medical Science
Full name of responsible person
Street address
City
Yazd
2
Recruitment center
Name of recruitment center
Shahid Sadoghi University of Medical Science- Yazd Dental School
Full name of responsible person
Street address
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shahid Sadoghi University of Medical Science
Full name of responsible person
Dr Fatemeh Ezodini - Vice Chancellor for Research, Shahid Sadoghi University of Medical Science
Street address
Shahid Bahonar Sq. Yazd
City
Yazd
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, Shahid Sadoghi University of Medical Science
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
Shahid Sadoghi University of Medical Science-Yazd Dental School
Full name of responsible person
Arezoo Khabazian
Position
Doctor/ Post Graduate Student of Periodontics
Other areas of specialty/work
Street address
Yazd Dental School, Fazaye Sabz Sq. Yazd
City
Yazd
Postal code
Phone
+98 35 1621 2222
Fax
Email
arezookhabazian@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoghi University of Medical Science-Yazd Dental School
Full name of responsible person
Ahmad Haerian Ardakani
Position
Associated Professor at Periodontics Department of Yazd Dental School
Other areas of specialty/work
Street address
Yazd, Fazaye Sabz Square- Yazd Dental School
City
Yazd
Postal code
Phone
+98 35 1621 2222
Fax
Email
ahmad.haerian@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Sadoghi University of Medical Science-Yazd Dental School
Full name of responsible person
Arezoo Khabazian
Position
Doctor, Post Graduate Student of Periodontics
Other areas of specialty/work
Street address
Yazd
City
Yazd
Postal code
Phone
+98 35 1621 2222
Fax
Email
arezookhabazian@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)