The aim of this study was to evaluate the clinical effectiveness of xanthan – based CHLO-SITE gel(xan-CHX) as an locally adjunctive therapy to SRP in treatment of moderate to sever periodontitis. In a randomized clinical trial, 6 patients with moderate to severe chronic periodontitis were selected. Each of the subjects had at least three pockets 4-7mm deep. 28 randomly selected pockets were subjected to control group and 44 pockets to test group. Scaling and root planning (SRP) were done in all pockets. In test group, in addition to SRP, xan-CHL gel was also injected in the pockets. Two weeks later again gel therapy would be administrated for experimental group. Clinical indices(PPD,CAL,BOP, PI ) before and three months after treatment were measured by paired T-test, ki squired and Kruskal-wallis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201101095570N1
Registration date:2011-02-27, 1389/12/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-02-27, 1389/12/08
Registrant information
Name
Parichehr Behfarnia
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1666 1707
Email address
behfarnia@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for Research of Isfahan University Of Medical Sciences
Expected recruitment start date
2007-08-23, 1386/06/01
Expected recruitment end date
2008-06-04, 1387/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Clinical Effect of Local Delivery of Xanthan-based CHLO-SITE gel with Scaling and Root planning in Chronic Periodontitis
Public title
Clinical Effect Of Chlorohexidin Gel In Chronic Periodontitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion creteria: Moderate to sever periodontitis; with at least 3 pocket with 4-7 probing depth; good patient coapration
Exclusion criterria: Suffering from systemic disease; taking such drugs as antibiotics over three months prior to the study period; failing to coaperate appropriatly; smoking or having recived periodontal treatment in the three months prior to the study period
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committe of Isfahan University Of Medical Sciences
Street address
Hezar Jarib
City
Isfahan
Postal code
8174673461
Approval date
2008-08-22, 1387/06/01
Ethics committee reference number
386168
Health conditions studied
1
Description of health condition studied
Chronic Periodontitis
ICD-10 code
KO5.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
Plaque Index
Timepoint
Base line(before treatment), 3 months after treatment
Method of measurement
Silness and Loe index
2
Description
Bleeding Index
Timepoint
Base line(before treatment), 3 months after treatment
Method of measurement
Ainamo and Bay index
3
Description
Probing Depth
Timepoint
Base line(before treatment), 3 months after treatment
Method of measurement
Clinical Evaluation(Probing by Williams prob, from gingival margin to depth of pocket)
4
Description
Level Of Attachment
Timepoint
Base line(before treatment), 3 months after treatment
Method of measurement
Cilnical Evaluation (Probing from CEJ to the depth of pocket)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Oral hygine instruction, Scaling and Root planing, Injection of xan-CHX after SRP AND 2weeks later
Category
Treatment - Drugs
2
Description
Control group: Oral hygine instruction, Scaling and Root planing
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodontics Department, Dental School, Isfahan University Of Medical Sciences
Full name of responsible person
Parichehr Behfarnia
Street address
Dental School, Isfahan University Of Medical Sciences
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor For Research Of Isfahan University Of Medical Sciences
Full name of responsible person
Dr. Omid Savabi
Street address
Hezar Jarib, Dental School, Isfahan University Of Medical Sciences
City
Isfahan
Grant name
تحقبقاتی
Grant code / Reference number
386168
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor For Research Of Isfahan 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
Dental School, Isfahan University Of Medical Sciences
Full name of responsible person
Parichehr Behfarnia
Position
Assistant Professor
Other areas of specialty/work
Street address
Hezar Jarib
City
Isfahan
Postal code
8174673461
Phone
+98 79 22870
Fax
+98 31 1668 7080
Email
behfarnia@den.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dental School, Isfahan University Of Medical Sciences
Full name of responsible person
Parichehr Behfarni
Position
Assistant Professor
Other areas of specialty/work
Street address
Hezar Jarib
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2870
Fax
+98 31 1668 7080
Email
behfarnia@dnt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dental School, Isfahan University Of Medical Sciences
Full name of responsible person
Parichehr Behfarnia
Position
Assistant Professor
Other areas of specialty/work
Street address
Hezar Jarib, Dental School, Isfahan University Of Medical Sciences
City
Isfahan
Postal code
8174673461
Phone
+98 31 1792 2870
Fax
+98 31 1668 7080
Email
behfarnia@den.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)