Introduction: The present study evaluated staining as a result of the chlorhexidine use and the role of sodium perborate in removing stains; in addition, the amount of decreases in plaque and gingival inflammation and the role of sodium perborate in chlorhexidine efficacy in removing plaque and decreasing gingival inflammation were evaluated.
Materials and methods: In the present clinical trial 40 patients referring to the Department of Periodontics, who had mild-to-moderate gingivitis were randomly divided into two groups with a parallel study design and were evaluated in a double-blind scheme. At baseline the patients underwent scaling, root planing and polishing procedures. After two weeks, plaque indexes (PI), gingival indexes (GI) and bleeding indexes (BI) were determined and recorded. In the control group 0.2% chlorhexidine gluconate mouthwash was used twice in 24 hours for 30 seconds for 14 days. In the experimental group 0.2% chlorhexidine gluconate mouthwash containing 0.2% sodium perborate was used for 30 seconds. The subjects refrained from toothbrushing during this period. After 14 days the above-mentioned indexes were again determined and recorded, along with staining indexes.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102245900N1
Registration date:2011-04-14, 1390/01/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-04-14, 1390/01/25
Registrant information
Name
Ali Zarandi
Name of organization / entity
Hamedan dental faculty
Country
Iran (Islamic Republic of)
Phone
+98 81 1825 0498
Email address
zarandi.ali@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan dental faculty
Expected recruitment start date
2010-03-21, 1389/01/01
Expected recruitment end date
2011-02-20, 1389/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An in vitro/in vivo evaluation of the effect of chlorhexidine in combination with sodium perborate on gingivitis, plaque and tooth surface staining
Public title
An evaluation of the effect of chlorhexidine in combination with sodium perborate on gingivitis, plaque and tooth surface staining
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Presence of at least 12 anterior teeth; Mild-to-moderate gingivitis, no pockets, no attachment loss; Informed written consent form. Exclusion criteria: allergic reaction to chlorhexidine; smoking habits; history of antibiotic use in the past three months; pregnancy; movable or fixed orthodontic appliances or movable prostheses; irremovable staining (due to tetracycline or fluoride).
Age
From 20 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Ethics committee of Hamedan University of Medical Sciences and Health Services
Street address
Vice chancellor for research, Hamedan University of Medical Sciences and Health Services, Fahmideh Street
City
Hamedan
Postal code
65178/518
Approval date
2010-02-28, 1388/12/09
Ethics committee reference number
175840/9/35/16/پ
Health conditions studied
1
Description of health condition studied
gingivitis
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis
2
Description of health condition studied
tooth surface staining
ICD-10 code
K03.7
ICD-10 code description
Posteruptive colour changes of dental hard tissues
Primary outcomes
1
Description
staining
Timepoint
After two weeks
Method of measurement
staining index designed by Lobene
Secondary outcomes
1
Description
gingivitis + plaque
Timepoint
After two weeks
Method of measurement
plaque indexes (PI), gingival indexes (GI) and bleeding indexes (BI)