Comparison of antibacterial effect, tooth staining and taste disturbance of 0.2% and 0.12% Chlorhexidine mouth rinses in patients with Gingivitis or mild Periodontitis
Aim: The use of Chlorhexidine is strongly recommended in prevention and treatment of periodontal diseases. This product unfortunately has some side effects such as extrinsic tooth staining and taste disturbance. The aim of this clinical trial is comparison of the tooth staining, taste disturbance and antibacterial effect of 0.2% with 0.12% Chlorhexidine mouthrinses. If the low dose mouthwash shows the same antibacterial effect as the higher dose with lesser side effects, it can be an appropriate substitute.
Study Design: Interventional, randomized, double blind, unicenter, no placebo, cross over clinical trial.
Inclusion Criteria: Patients with gingivitis or mild periodontitis. Exclusion criteria: Hypersensitivity to mouthwashes, pregnancy, nursing Period. All subjects received a complete dental prophylaxis before using either mouthwash. They were asked to use One of the Chlorhexidine mouthwashes was randomly given to the patients to use it two times a day for a 7 days period during which any mechanical plaque control was not allowed. After one week of wash out period the subjects entered the second 7 days period using the other product in the same manner. After each period, discoloration index and taste disturbance were measured. Also before and after mouthwash application, microbial plaque was obtained to microbial culture.
Sample Size: Fifty-two interventions in 26 patients(18-60) without sex limitation
Intervention: Utilization of mouthwashes
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013021612487N1
Registration date:2013-10-22, 1392/07/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-10-22, 1392/07/30
Registrant information
Name
Shirin Amini
Name of organization / entity
Khorasgan Branch, Islamic Azad University, Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 1535 4053
Email address
sh.amini@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2011-02-18, 1389/11/29
Expected recruitment end date
2012-02-19, 1390/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of antibacterial effect, tooth staining and taste disturbance of 0.2% and 0.12% Chlorhexidine mouth rinses in patients with Gingivitis or mild Periodontitis
Public title
Comparison of the antibacterial effect, tooth Staining and taste disturbance of two Iranian mouthrinses
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: The patients with gingivitis or mild periodontitis with 6 anterior teeth.
Exclusion criteria: Severe periodontitis, any pathological Conditions in oral mucosal membranes, pregnancy or nursing period, application of Orthodontic appliances or partial denture, smoking, disturbed oral taste, hypersensitivity to mouthwashes.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Randomization: This study had two 7days periods. During these periods the subjects used one of the mouthwashes randomly. There was a wash out period between these two periods. Randomization carried out by throwing the coin in which 26 patients divided randomly to two groups each including 13 patients. The patients of one group used the 0.2% Chlorhexidine mouthwash during the first period and the patients of the second group used the 0.12% Chlorhexidine mouthwash during the first period.
Blindness: this study was double blind because the mouthwashes were given to the patients in uniform bottles by another person other than the investigator. At the end of the study he was asked to mention the set up for application of these mouthwashes by the patients.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Khorasgan Branch, Islamic Azad University
Street address
Dental School, Khorasgan Branch, Islamic Azad University, University Boulevard, Arghavanieh Street, Eastern Jey Street, Isfahan, Iran