Comparison of the effects of one-stage full-mouth disinfection and quadrant-wise scaling and aoot planing on serum levels of IL-27 and clinical parameters following treatment of moderate-to-severe chronic periodontitis
The aim of the present study was to compare the inflammatory processes in the two one-stage full-mouth disinfection technique and the quadrant-wise scaling and root planning procedure to determine IL_27 serum level. The subjects who have chronic to sever periodontitis and without history of systemic condition which delay would healing and without using of immune-suppressive drugs are selected to study.In the test group scalling and root planning with disinfectin of oralcavity was done.The quadrant-wise patients underwent scaling and root planing procedures at two-week intervals for each quadrant(6 weeks ).Blood samples were taken in 3 times(before,2month and 4 month after scaling and root planinig)
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013051313312N1
Registration date:2013-08-04, 1392/05/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-08-04, 1392/05/13
Registrant information
Name
Zohre Babaloo
Name of organization / entity
Tabriz Univercity of Medical Scinece
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 5965
Email address
zbabaoo@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tooth and gingiva diseases research center
Expected recruitment start date
2012-08-05, 1391/05/15
Expected recruitment end date
2013-03-10, 1391/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of one-stage full-mouth disinfection and quadrant-wise scaling and aoot planing on serum levels of IL-27 and clinical parameters following treatment of moderate-to-severe chronic periodontitis
Public title
Comparison
of One-Stage Full-Mouth Disinfection and
Quadrant-Wise Scaling and Root Planing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:The subjects had at least 12 teeth (irrespective of third molars and teeth with orthodontic appliances, bridgeworks, crowns and implants) with the 30% of the teeth with clinical attachment loss of ≥3 mm؛ radiographic evidence of bone loss in each group.
Exclusion criteria: included systemic conditions؛ conditions which delay would healin؛ a history of radiotherapy or immune-suppressive treatment modalities؛ pregnancy or breast-feeling؛ use of systemic antibiotics during the two previous months؛ a history of continuous consumption of NSATDs ؛ a history of scaling and root planing during the previous year
Age
From 25 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz university of medical sciences
Street address
Tabriz, Golgasht st, Tabriz university of medical sciences, No 2 central building, 3th floor
City
Tabriz
Postal code
5166614711
Approval date
2013-04-30, 1392/02/10
Ethics committee reference number
921
Health conditions studied
1
Description of health condition studied
chronic periodontits
ICD-10 code
ko5.3
ICD-10 code description
chronic periodontits
Primary outcomes
1
Description
serum levels of IL_27
Timepoint
befor intervation,2 month and 4 month after intervation
Method of measurement
special laboratory kit
Secondary outcomes
1
Description
bleeding on probing
Timepoint
befor intervation,2 month and 4 month after intervation
Method of measurement
probing
2
Description
clinical attachment level
Timepoint
befor intervation,2 month and 4 month after intervation
Method of measurement
distance between floor of pocket to CEJ
3
Description
probing depth
Timepoint
befor intervation,2 month and 4 month after intervation
Method of measurement
distance between floor of the pocket to free gingiva
Intervention groups
1
Description
After blood samples were taken in the test group , the entire oral cavity was cleaned by an ultrasonic scaler in two sessions in less than 24 hours in order to decrease pathogenic organisms’ counts. Subgingival irrigation of all the pockets was carried out with 0.2% chlorhexidine using an insulin syringe in order to remove all remaining bacteria. An antiseptic agent (0.2% chlorhexidine) was used to brush the dorsum of the tongue to decrease the bacterial load in the area; an antiseptic mouthwash (0.2% chlorhexidine) was used to reduce bacterial load in the saliva and on the tonsils.
Category
Treatment - Other
2
Description
The control group patients underwent scaling and root planing procedures at two-week intervals for each quadrant after blood samples were taken.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz University of Medical Sciences
Full name of responsible person
Amirreza Babaloo
Street address
Dentistry faculty, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Seid Kazem Shakouri
Street address
Tabriz University of Medical Sciences, Golgasht
City
Tabriz
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, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Amirreza Babaloo
Position
Periodontist Spesialist
Other areas of specialty/work
Street address
Dentistry faculty, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Postal code
Phone
+98 914 311 6842
Fax
Email
amirezababaloo@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Amirreza Babaloo
Position
Periodontics Spesialist
Other areas of specialty/work
Street address
Tabriz, Dental Factualy
City
Tabriz
Postal code
Phone
00
Fax
Email
amirrezababaloo@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz Dental Faculty
Full name of responsible person
Said Amjad Amini
Position
Undergraduated Student
Other areas of specialty/work
Street address
Golgasht st,Dental faculty
City
Tabriz
Postal code
Phone
+98 87 4325 0196
Fax
66819_53914
Email
amjadamini283@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)