A Clinical Trial Study of the Chlorhexidine Mouthrinses with Alcohol (Hexodine) and without Alcohol (Epimax) Effect on Gingival Clinical Parameters in Choronic Gingivitis Patients
Objective: The purpose of this study is to investigate the effect of Chlorhexidine mouthrinses with Alcohol (Hexodine) and without Alcohol (Epimax) on gingival parameters in gingivitis patients. Design: This study has a randomized, double-blind, with control group, single-center design. For this respect, the mouthrinse tubes are labeled into the group A and B by third person (except patients and researcher). Then the patients are assigned randomly to the group A or B by the coin tossing. Major Inclusion criteria: gingivitis periodontitis disease; age over 18 years; not having systemic disease; no periodontal treatment in the last six months. Major Exclusion criteria: other treatments for periodontal disease during the study period. Study population: patients with chronic gingivitis disease. Sample size: 32 patients. Interventions: Chlorhexidine mouthrinses with Alcohol (Hexodine); Chlorhexidine mouthrinses without Alcohol (Epimax). Intervention time: 21.06.2012. Main Outcome Measures: Changes in gingival, plaque and stain indexes after use of mouthrinses.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201504244877N27
Registration date:2015-08-21, 1394/05/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-08-21, 1394/05/30
Registrant information
Name
Jaber Yaghini
Name of organization / entity
Isfahan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 31 1434 2136
Email address
j_yaghini@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Government: Vice Chancellor of Research, School of Dentistry, Isfahan University of Medical Sciences
Expected recruitment start date
2012-05-21, 1391/03/01
Expected recruitment end date
2012-06-21, 1391/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Clinical Trial Study of the Chlorhexidine Mouthrinses with Alcohol (Hexodine) and without Alcohol (Epimax) Effect on Gingival Clinical Parameters in Choronic Gingivitis Patients
Public title
Comparison of efficacy and side effects of Chlorhexidine mouthrinses with (Hexodine) and without Alcohol (Epimax)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with gingivitis disease; age over 18 years; lack of systemic disease; no pregnancy; no previous periodontal treatment and systemic antibiotics therapy in the last 6 months; not being smoker.
Exclusion criteria: the patient’s unwillingness to continue the treatment; being under other treatment and taking medications which may affect the result during the study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
A coin tossing is used for Randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar jerib St, Isfahan, Iran.
City
Isfahan
Postal code
8174673461
Approval date
2012-05-21, 1391/03/01
Ethics committee reference number
391030
Health conditions studied
1
Description of health condition studied
Gingivitis
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis
Primary outcomes
1
Description
Gingival Index (Löe and Silness score)
Timepoint
Two weak after intervention
Method of measurement
Observation of index score
2
Description
Plaque index (o'leary)
Timepoint
Two weak after intervention
Method of measurement
Observation of index score
3
Description
lobene stain index
Timepoint
Two weak after intervention
Method of measurement
Observation of index score
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Epimax mouthwash (Non-Alcoholic Chlorhexidine 0 .12 %) made by Emad pharmaceutical Co. Instruction: 15 milliliter of mouthwash for 60 seconds, 2 times a day (every 12 hours) for 2 weeks.
Category
Treatment - Drugs
2
Description
Control group: Hexodine mouthwash (Alcoholic Chlorhexidine 0.12%) made by Donyaye Behdasht Laboratories co. Instruction: 15 milliliter of mouthwash for 60 seconds, 2 times a day (every 12 hours) for 2 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodontal department, School of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Dr Jaber Yaghini
Street address
Periodontal department, School of Dentistry, Isfahan University of Medical Sciences, Hezarjerib st., Isfahan,Iran.
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor of Research, Isfahan University of Medical Sciences
Full name of responsible person
Dr Omid Savabi
Street address
Vice chancellor of Research, School of Dentistry, Isfahan University of Medical Sciences, Hezarjerib st., Isfahan,Iran.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor of Research, 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
Periodontal department, School of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Dr Jaber Yaghini
Position
Assistant professor
Other areas of specialty/work
Street address
Periodontal department, School of Dentistry, Isfahan University of Medical Sciences, Hezarjerib st., Isfahan,Iran.
City
Isfahan
Postal code
8174673461
Phone
+98 317922825
Fax
Email
j_yaghini@dnt.mui.ac.ir.
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Periodontal department, School of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Dr Jaber Yaghini
Position
Assistant professor
Other areas of specialty/work
Street address
Periodontal department, School of Dentistry, Isfahan University of Medical Sciences, Hezarjerib st., Isfahan,Iran.
City
Isfahan
Postal code
8174673461
Phone
+98 317922825
Fax
Email
j_yaghini@dnt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Periodontal department, School of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Dr Jaber Yaghini
Position
Assistant professor
Other areas of specialty/work
Street address
Periodontal department, School of Dentistry, Isfahan University of Medical Sciences, Hezarjerib st., Isfahan,Iran.
City
Isfahan
Postal code
8174673461
Phone
+98 317922825
Fax
Email
j_yaghini@dnt.mui.ac.ir.
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)