Clinical evaluation of the effect of 2% chlorhexidine in dentin treatment procedure on the postoperative sensitivity of posterior composite resin restorations
Post operative sensitivity (POS) following composite restorations still remains as a major problem. The aim of this study is clinical evaluation of the effect of 2% chlorhexidine in dentin treatment procedure on the POS of posterior composite resin restorations. 30 patients (aged 20-35 years old) with two posterior teeth with similar caries on both sides of jaw are selected according to the inclusion and exclusion criteria. Patients participate in the study with their consent. After cavity preparation, each of the selected teeth in an individual randomly restore with one of the following methods: tooth in the control group will etch with phosphoric acid 37% (Ultradent) and then restored with dentin bonding system (Single Bond, 3M) and composite (Bisco,3M) according to the manufacturer's instructions. In the other group restoration is similar to the control group but after etching, tooth is wet with cholorhexidine 2% for 60 second. Patients are followed in the intervals of one day, one week, one month and six months. POS will be examined with visual analogue scale method and clinical status of restoration will evaluated with modified USPHS criteria.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104236267N1
Registration date:2012-01-10, 1390/10/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-01-10, 1390/10/20
Registrant information
Name
Hila Hajizadeh
Name of organization / entity
Mashad Dental School, Department of Restorative Dntistry
Country
Iran (Islamic Republic of)
Phone
+98 51 1765 2219
Email address
hajizadehh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2011-04-21, 1390/02/01
Expected recruitment end date
2011-06-22, 1390/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of the effect of 2% chlorhexidine in dentin treatment procedure on the postoperative sensitivity of posterior composite resin restorations
Public title
Effect of chlorhexidine(CHX) on post operative sensitivity
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Having two teeth with similar caries lesion in each side of the jaw; indication for composite restoration and age 20 to 35 years old.teeth were not restored befored. Patient wants tooth color restoration
Exclusion criteria: teeth with restoration; allergy to composite; participation in other test; negative response to vitality test; symptom of irreversible pulpities and necrosis; pregnancy or other systemic disease and tooth sensitivity due to cervical abrasion
Age
From 20 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
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 Comittee of Mashhad University of Medical Sciences
Street address
Ghorashee building, Daneshgah street,
City
Mashhad
Postal code
Approval date
2011-02-12, 1389/11/23
Ethics committee reference number
89627
Health conditions studied
1
Description of health condition studied
Post operative sensiivity
ICD-10 code
K03.8
ICD-10 code description
Other specified diseases of hard tissues of teeth
2
Description of health condition studied
Clinical evaluation of teeth restoration
ICD-10 code
K03.9
ICD-10 code description
Disease of hard tissues of teeth, unspecified
Primary outcomes
1
Description
Post operative sensitivity
Timepoint
One week, 1 and 6 months after intervention
Method of measurement
Visual analouge scale
Secondary outcomes
1
Description
Cinical evaluation of restoration
Timepoint
One week, 1 & 6 months after intervention
Method of measurement
US Public Health Service (USPHS) Criteria
Intervention groups
1
Description
Restoration with application of chlorhexidine
Category
Prevention
2
Description
restoration with no chlorhexzidine
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashad Dental School
Full name of responsible person
Street address
City
Mashad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Jalil Tavakol Afshar
Street address
Mashhad University of Medical Sciences, Buali instittue, Buali squar.
City
Mashad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?