The aim of this study is to determine the effect of laser on the sensitivity after composite restorations.
Design
Controlled clinical trial with parallel group. Randomized. Double-blind.
Simple randomization is done for each patient by using a random number table.Thus, depending on the number if being even or odd ,the patient's left or right side is considered as the intervention group and the other side as the control group.
Settings and conduct
This study is performed on patients referred to department of restorative ward of dental faculty of Hamadan University of Medical Sciences, Iran
Participants/Inclusion and exclusion criteria
Patient should have two decayed premolar teeth at a proximal surface in right and left side of the mandible or maxilla. Teeth should have Class II caries in the mesial or distal. Teeth should be vital with no traumatic history, no cervical caries, not have any previous fillings, no periodontal disease. If the patients have used toothpaste and desensitizing solution over the past two months Or have used analgesics for 72 hours before test, Will be excluded from study.
Intervention groups
Intervention group 1:Premolar tooth on one side of the patient's mandible / maxillary jaw, which has a proximal surface decay is Considered As an intervention group. After preparing the cavity and isolation, the diode laser is applied for 30 seconds, then the adhesive is applied and the composite restoration is inserted.
Intervention group 1:Premolar tooth on other side of the patient's mandible / maxillary jaw, which has a proximal surface decay is Considered as an control group. After preparing the cavity and isolation, the radiated with placebo red light for 30 seconds, then the adhesive is applied and the composite restoration is inserted.
Main outcome variables
Tooth sensitivity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190122042457N1
Registration date:2019-03-03, 1397/12/12
Registration timing:retrospective
Last update:2019-03-03, 1397/12/12
Update count:0
Registration date
2019-03-03, 1397/12/12
Registrant information
Name
Mojgan Taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3829 1439
Email address
mo.taheri@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-15, 1397/06/24
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of diode laser (940nm) on postoperative sensitivity in class II composite restorations (randomized clinical trial, double blind)
Public title
effect of diode laser on postoperative sensitivity in composite restorations
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients should have two decayed premolar teeth at a proximal surface in right and left side of the mandible or maxilla.
Teeth should have Class II caries in the mesial or distal. (Depth about 2 mm and less than 4 mm Bacolingual extent)
Teeth should be vital with no traumatic history
The teeth should not have cervical caries
The teeth should not have any previous fillings.
The teeth should not have a history of hypersensitivity and pulpitis
The patient should not take the analgesic medication 72 hours before the test
Patients should have no systemic disease that affect their periodontal and dental conditions; like Diabetes.
Exclusion criteria:
deep carious lesions on teeth that need base and liner.
the patient has used toothpaste and anti-allergic solution over the past two months.
The patient uses anti-inflammatory and analgesic drugs routinely.
The patient has allergies to the restorative material in this study
The patient has a history of neurological and psychological illnesses.
The patient has very weak dental hygiene and rapid progression of caries.
The patient has a history of disease or periodontal surgery in the selected tooth.
Age
From 20 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
Patients have two collateral decayed premolar in disto-oclusal or mesio-oclusal surface( in maxilla or mandible ). Randomly, a teeth on one side of the jaw will be considered as a control group and the collateral tooth in the same jaw will be considered as the intervention group .
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done using the numerical randomization table.In a patient with two decayed premolar teeth, one is randomly designate in the intervention(laser) group and the other one allocate in the control group.
The randomized table of numbers is generated by computers that customize the numbers randomly in multiple columns and rows. Examples of these tables are available on the Internet and statistical books. After get the table, the number is selected by closing the eye and inserting the finger or tip of the pen on the point of the table and moving to the right and the numbers on the path are recorded, this is repeated until 30 samples were obtained for 30 patients in the study, respectively. So if the selected number is even, the left tooth is considered as a lasers group and the right tooth is considered as the control group. And if the number is odd, the right tooth is considered as a lasers group and the left tooth is considered as the control group
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient is kept blinded by receiving placebo radiation in the control tooth.
The practitioner and who perform the sensitivity test are two individuals in this study. So the practitioner will carry out the intervention treatment. and the examiner blindly tests the teeth sensitivity at the follow-up sessions until the end of the study.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی همدان
Street address
Shahid Fahmideh St
City
Hamadan
Province
Hamadan
Postal code
6517838677
Approval date
2018-06-30, 1397/04/09
Ethics committee reference number
IR.UMSHA.REC.1397.232
Health conditions studied
1
Description of health condition studied
Tooth sensitivity
ICD-10 code
K03.89
ICD-10 code description
Other specified diseases of hard tissues of teeth
Primary outcomes
1
Description
The sensitivity of the tooth after the cold test by using the Visual analog scale
Timepoint
baseline measurement before filling teeth, one day,two week and One month after treatment.
Method of measurement
To do a cold test, a swab sprayed with cold spray and placed in the center of the teeth for 5 seconds. The patient is then asked to select 0 to 10 numbers by Visual Analogue Scale to report the severity of pain, so that he will score 10 for the most pain and choose 0 for no pain.
Secondary outcomes
1
Description
Tooth sensitivity to different stimuli
Timepoint
baseline measurement before filling teeth, one day, two week and One month after treatment.
Method of measurement
Questionnaire-The patient responds yes or no to questions about tooth susceptibility with heat and cold and sweet dishes
Intervention groups
1
Description
Control group: After cavity preparation and just before the restoration placement, the tooth in the control group is subjected to placebo irradiation from red light for 30 s. Etching and bonding procedures are done by a self-etch adhesive (Single Bond Universal, 3M ESPE ,USA) according to the manufacturer’s instructions, and then the class II cavities is restored by a resin composite (Filtek Z250 , 3M ESPE ,USA) by incremental technique. After curing, finishing is accomplished with fine-grit diamond burs (Brasseler) and Sof-Lex polishing disc system (3MESPE, St Paul,MN, USA) underwater cooling to obtain a smooth surface.
Category
Treatment - Devices
2
Description
Intervention group: . After cavity preparation and just before the restoration placement, the teeth in the experimental group is subjected to irradiation from a low-level red laser (Ezlase 940, Biolase, California, USA), emitting a wavelength of 940 nm in a continuous pulse using E4 tip. The output power of the apparatus is1W, and each tooth is irradiated for 30 s.Etching and bonding procedures were done by a self-etch adhesive (Single Bond Universal, 3M ESPE ,USA) according to the manufacturer’s instructions, and then the class II cavities is restored by a resin composite (Filtek Z250 , 3M ESPE ,USA) by incremental technique. After curing, finishing is accomplished with fine-grit diamond burs (Brasseler) and Sof-Lex polishing disc system (3MESPE, St Paul,MN, USA) underwater cooling to obtain a smooth surface.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Hamadan faculty of dentistry, department of restorative dnetistry
Full name of responsible person
Mojgan Taheri
Street address
Faculty of dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh St
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 1086
Fax
+98 81 3838 1085
Email
taheri.mojgan.86@gmail.com
Web page address
http://dentistry.umsha.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
saeid bashirian
Street address
Vice chancellor for research, Hamadan University of Medical Sciences, Shahid Fahmideh St
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Email
s_bashirian@yahoo.com
Web page address
http://research.umsha.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mojgan Taheri
Position
resident of restorative dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh St,
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81338381026
Email
taheri.mojgan.86@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Logman Rezaei Sofi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh St
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 1086
Email
loghmansofi@umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mojgan Taheri
Position
resident of operative dentistry
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh St
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 1084
Email
taheri.mojgan.86@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Non-identifiable individual data, participants protocol, study protocol, statistical analysis map, informed consent form, clinical study report, codes used in the analysis, and classification system (data dictionary) after the end of the study and after publication of the article will be published on this site.
When the data will become available and for how long
Six months after the publication of the article
To whom data/document is available
All people will have access to information
Under which criteria data/document could be used
Data is available for study by other dentists and researchers on clinical trials data with the mention of the source.
From where data/document is obtainable
To get the data, Refer to the person responsible for the study: Mojgan Taheri, email: taheri.mojgan.86@gmail.com, 00989183152146
What processes are involved for a request to access data/document
The applicant, after disclosure of the name and contact information, and the research center, should explain a summary of his research topic and how to use the data, and ensure that after using the data, the source will be mentioned.