Effect of adjunctive locally delivered doxycycline microspheres on clinical parameters and the gingival crevicular fluid matrix metalloproteinase-8 levels in chronic periodontitis
The aim of current investigation was to study effect of periodontal non-surgical treatment along with locally delivered doxycycline microspheres on clinical parameters and the gingival crevicular fluid matrix metalloproteinase -8 level in patients with chronic periodontitis.
Present single-blind study was carried out on patients referred to faculty of dentistry of Tabriz, having moderate to severe chronic periodontitis, at least four teeth with probe depth of 4-6 mm where 2 teeth were in one Quadrants and two other teeth were at the opposite Quadrants.
The patients had no sensitivity to tetracycline antibiotics, no periodontal treatment for recent 6 months,no systematic difficulty. The patient was excluded from the study if he had SRP, periodontal treatment till 6 months before, every systematic disorder and allergy history to tetracycline antibiotics.
25 patients with moderate to severe chronic periodontitis were selected .The research method was split mouth. Two teeth were selected as text group and the two adjacent teeth were also selected as control group. No Baseline sampling intervention was considered in the groups to determine mmp8 level of Gingival Crevicular fluid and evaluate clinical parameters.
So, the treatment was non-surgical periodontal in the both groups and, instantly, locally delivered doxycycline was placed in the pockets in the test group. Sampling and clinical parameters evaluation was carried out again 1 and 3 months later. One month is needed for taking the patient and four months for treatment.
initial result was evaluation of changes inmmp8 level of Gingival Crevicular fluid.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201601173690N6
Registration date:2016-03-13, 1394/12/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-13, 1394/12/23
Registrant information
Name
Masoomeh Faramarzie
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1385 4863
Email address
faramarzim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Gingival and dental research center of Tabriz dentistry faculty
Expected recruitment start date
2016-02-18, 1394/11/29
Expected recruitment end date
2016-05-26, 1395/03/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of adjunctive locally delivered doxycycline microspheres on clinical parameters and the gingival crevicular fluid matrix metalloproteinase-8 levels in chronic periodontitis
Public title
Effect of adjunctive locally delivered doxycycline microspheres on clinical parameters and the gingival crevicular fluid matrix metalloproteinase-8 levels in chronic periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with moderate to severe chronic periodontitis with at least 4 teeth and 4-6mm probe depth were included in the study whose two teeth were at one quadrantand the other two teeth at opposite quadrant of the same patient. The patients shouldn’t have sensitivity to antibiotics of tetracycline group and they also, should not have periodontal treatment till 6 months before. Moreover they shouldn’t take antibiotics 3 months before treatment. Finally they shouldn’t have systemic problem which affects periodontal tissues.
If the patient had one of following cases, he would be excluded from the study: Having SRP and every periodontal treatment till 6 months before the study, presence of every systemic disorder affecting periodontal position, having allergy history to doxycycline or antibiotics of tetracycline group and taking antibiotics 3 months before the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
University of Tabriz medical science
Street address
Faculty of dentistry , Tabriz university of medical sciences tabriz
Ng/ml ,ELISA using Quantikine human total MMP-8 immunoassay kits
Secondary outcomes
1
Description
Evaluation of prob depth , attachment level and bleeding of probing
Timepoint
Baseline, 1and 3 months after treatment
Method of measurement
By prob , pocket depth and attachment level :mm
Intervention groups
1
Description
Test group: Initial sampling was carried out before every intervention to determine mmp8 level of gingival crevicular fluid and evaluate clinical parameters including probe depth, attachment level and bleeding of probing. Hence,the treatment was periodontal non surgical(i.e.Scailing and Root planing ) 10% local doxycycline was placed , instantly, inside the pocket in the test group.1-3months later the sampling and evaluation of clinical parameters were repeated.
Category
Treatment - Drugs
2
Description
Control groupInitial sampling was carried out before every intervention to determine mmp8 amount of Gingival Crevicular fluid and evaluate clinical parameters including probe depth, Attachment level and bleeding of probing. Hence, the treatment was periodontal non-surgical (i.e. Scailing and Roo planing). 1-3 months later the sampling and evaluation of clinical parameters were repeated.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of dentistry , Tabriz university of medical science
Full name of responsible person
Dr faramarzi
Street address
Faculty of dentistry , Tabriz university of medical science
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Gingival and dental research center of Tabriz dentistry faculty
Full name of responsible person
Dr shahi
Street address
Faculty of dentistry ,
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Gingival and dental research center of Tabriz dentistry faculty
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
Faculty of dentestery
Full name of responsible person
Dr zahra marami gezelje
Position
Resident of periodontics
Other areas of specialty/work
Street address
Faculty of dentestery Golgasht
City
Tabriz
Postal code
Phone
+98 41 3335 5968
Fax
Email
Marami-zahra@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of dentistry , Tabriz university of medical science
Full name of responsible person
Dr faramarzi
Position
Associated prof
Other areas of specialty/work
Street address
Faculty of dentistry, golphasht ave
City
Tabriz
Postal code
5166614711
Phone
+98 41 3335 5968
Fax
Email
Faramarzim@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Faculty of dentistry
Full name of responsible person
Dr Zahra marami gezelje
Position
Resident of periodontics
Other areas of specialty/work
Street address
Faculty of dentistry, golghasht ave
City
Tabriz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)