The objective of this trial is to investigate the efficacy of Chlorhexidine gel (CHLO-SITE) as adjunctive therapy of scaling and root planing on chronic periodontitis treatment.It's a double-blind clinical trial with a split mouth design. This is a single center clinical trial.
The main inclusion criteria are at least 2 millimeters of clinical attachment loss and at least 3 millimeters of pocket depth. Antibiotic therapy, pregnancy, malignancy and the risk of systemic disease affecting the periodontal status are the exclusion criteria. Sample size is twenty without sexual limits. In each patient mouth two sites consisting of two single-rooted teeth which conditions inclusion criteria is selected on both right and left sides of the mouth. Scaling and root planing will be performed in control group, in intervention group the basic treatment is performed and immediately after scaling and root planning sub gingival placement of Chlorhexidine gel will be done (as intervention). To evaluate the effectiveness of interventions in the treatment of chronic periodontitis variables including gingival index, probing depth, clinical attachment loss and plaque index were measured and compared between the two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015030321317N1
Registration date:2015-04-02, 1394/01/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-04-02, 1394/01/13
Registrant information
Name
Reza Mehrara
Name of organization / entity
Mashhad Univesity of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 38829501
Email address
mehrarar911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-04-20, 1391/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of sub gingival application of 1.5% Xanthan based Chlorhexidine gel and scaling and root planing on the treatment of chronic periodontitis
Public title
Evaluation of Xanthan based Chlorhexidine gel effects on chronic periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: at least 2 millimeters of clinical attachment loss; at least 3 millimeters of pocket depth; no history of periodontal surgery
Exclusion criteria: antibiotic therapy in past 12 month; pregnancy; systemic condition which is effective on periodontal condition; malignancy
Age
From 20 years old to 50 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Daneshgah St
City
Mashhad
Postal code
Approval date
2011-02-12, 1389/11/23
Ethics committee reference number
89589
Health conditions studied
1
Description of health condition studied
Chronic Periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic Pericoronitis
Primary outcomes
1
Description
Clinical pocket depth
Timepoint
Before intervention; 3 month after intervention
Method of measurement
Clinical measuring via periodontal probe
2
Description
Clinical attachment loss
Timepoint
Before intervention; 3 month after intervention
Method of measurement
Clinical measuring via periodontal probe
3
Description
Plaque index
Timepoint
Before intervention; 3 month after intervention
Method of measurement
Löe and Silness Plaque Index
4
Description
Gingival index
Timepoint
Before intervention; 3 month after intervention
Method of measurement
Löe and Silness Gingival Index
Secondary outcomes
empty
Intervention groups
1
Description
Scaling and root planing
Category
Treatment - Other
2
Description
Scaling and root planing and one time injection of Xanthan based 1.5% Chlorhexidine gel in periodontal pocket
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Periodontics, Mashhad Dental School
Full name of responsible person
Ali Forouzanfar
Street address
School of Dentistry, Vakilabad St
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ali Banihashemrad
Street address
School of Dentistry, Vakilabad St
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Majidreza Mokhtari
Position
Assistant Professor, Department of Periodontics
Other areas of specialty/work
Street address
School of Dentistry, Vakilabad St
City
Mashhad
Postal code
Phone
+98 51 3882 8503
Fax
Email
mokhtarimr@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad Univesity of Medical Sciences
Full name of responsible person
Reza Mehrara
Position
Doctor of Dental Surgery
Other areas of specialty/work
Street address
School of Dentistry, Vakilabad St
City
Mashhad
Postal code
Phone
+98 51 3882 8758
Fax
Email
mehrarar911@mums.ac.ir; rezamehrara@ymail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Reza Mehrara
Position
Postgraduate student of Orthodontics
Other areas of specialty/work
Street address
School of Dentistry, Vakilabad St
City
Mashhad
Postal code
Phone
+98 51 3882 8758
Fax
Email
mehrarar911@mums.ac.ir; rezamehrara@ymail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)