Tthe aim of the study was to compare the efficacy and potential complications of home-applied and in-office bleaching systems activated by different light sources in patients with discolored teeth after orthodontic treatment.
Design
The sample consisted of sixty volunteers with the chief complaint of tooth discoloration following orthodontic treatment. All the participants had discoloration in anterior maxillary teeth and their central incisors showed shade C2 or darker on the value-oriented shade guide. This study is a randomized single-blind clinical trial study.
Settings and conduct
the study was enrolled in the Department of Restorative Dentistry of Mashhad Dental School, Mashhad University of Medical Sciences, Mashhad, Iran.the study is single blind. (evaluator and statistician).
Participants/Inclusion and exclusion criteria
Volunteers referring to the Mashhad Dental School who have been past their orthodontic treatment for three months and have a clear color change in six anterior teeth
The exclusion criteria were patients who were pregnant or lactating; had moderate or severe discoloration resulting from pulpless teeth, tetracycline stains or fluorosis, as well as patients having smoking habits or those taking analgesic and anti-inflammatory drugs. Patients showing restored anterior teeth, non-carious cervical lesions, dental caries, periodontal disease or gingival recession, and subjects with previous tooth whitening procedures were also excluded from the sample
Intervention groups
group 1 received home bleaching
group 2 received in-office bleaching with the use of diode laser
group 3 received in-office bleaching with the use of plasma arc
group 4 received in-office bleaching without light source
Main outcome variables
Study group (by whitening method)
Color change rate
Severity of pain and tooth sensitivity
Complications after treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180912041012N1
Registration date:2018-10-25, 1397/08/03
Registration timing:registered_while_recruiting
Last update:2018-10-25, 1397/08/03
Update count:0
Registration date
2018-10-25, 1397/08/03
Registrant information
Name
Salehe Sekandari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9501
Email address
sekandaris961@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy and complications of several bleaching techniques on tooth discoloration following orthodontic treatment
Public title
Efficacy of several bleaching techniques following orthodontic treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have been past 3 months of their orthodontic treatment
Significant tooth discoloration in the six anterior teeth
Exclusion criteria:
Severe internal discolorations (tetracycline, fluorosis)
Periodontal disease
Tooth decays or restorations
Tooth sensitivity
Gastrointestinal disease
Age
From 14 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The group allocation was achieved by computer-generated tables-using random block size of 4. The details of the allocated groups were written on cards and were kept in sequentially numbered, opaque, and sealed envelopes. These cards were prepared by an independent operator who was not involved in the research protocol.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person evaluating the results of colorimetry and dental sensitivity ,complications and satisfaction of patients questionnaire and an the statistician was blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
At the beginning of the Vakil Abad Blvd., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138735499
Approval date
2016-02-03, 1394/11/14
Ethics committee reference number
IR.mums.sd.REC.1394.84
Health conditions studied
1
Description of health condition studied
TOOTH DISCOLORATION
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Color change rate
Timepoint
Before treatment (T1), 1 hour after the end of the bleaching procedure(T2), and one week after the end of the bleaching procedure(T3).
Method of measurement
Spectrometer device
2
Description
Tooth sensitivity rate
Timepoint
Before treatment (T1), 1 hour after the end of the bleaching procedure(T2), and one week after the end of the bleaching procedure(T3).
Method of measurement
Visual Analogue Scale
3
Description
Incidence or absence of complications and patient satisfaction