Determining and comparing the amount of bisphenol A in saliva after removal of residual adhesive with ultrasonic scaler and rotary system
Design
Clinical trial with two parallel groups with different interventions, single blind, randomized, phase 2 on 40 patients.
Randomization is done using Random allocation software (RAS).
Settings and conduct
In this study, 40 patients referred to the specialized department of Tabriz Dental School who receive fixed orthodontic treatment are randomly placed in two groups of 20 people. All patients with metal brackets and Light Cure composite and bonding will be treated. After the brackets are debonded with a plier, by the method of pulling the brackets through the plier, removing the adhesive residue from the surface of the tooth in the first group will be completely performed by an ultrasonic scaler and In the second group, first by a turbine with a carbide cone bur machine a large volume of adhesive will be removed and then the residual layer near the enamel will be removed by a low speed handpiece with a tungsten carbide bur. Then, using a calibrated pipette, 1 cc of saliva is collected from the vestibular buccal and sub lingual areas and stored in glass vials. High-performance liquid chromatography / mass spectrometer will be used to determine the level of bisphenol A.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with at least 16 bonded teeth.
Exclusion criteria:
Tobacco use (chewable and absorbable); Liver disease; Kidney disease; Taking drugs containing phenolic compounds.
Intervention groups
The first group: removal of adhesive with a rotary system
The second group: removal of adhesive with ultrasonic scaler
Main outcome variables
The amount of bisphenol identified in saliva
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200702047988N1
Registration date:2020-08-26, 1399/06/05
Registration timing:retrospective
Last update:2020-08-26, 1399/06/05
Update count:0
Registration date
2020-08-26, 1399/06/05
Registrant information
Name
Sara Seifi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5969
Email address
seifis@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-04, 1397/01/15
Expected recruitment end date
2018-06-29, 1397/04/08
Actual recruitment start date
2018-04-04, 1397/01/15
Actual recruitment end date
2018-06-29, 1397/04/08
Trial completion date
2018-06-29, 1397/04/08
Scientific title
Evaluation of Bisphenol Release in Saliva after Remaining Adhesive Removal in Orthodontic Patients Using Ultrasonic and Rotary Systems
Public title
Evaluation of Bisphenol Release in Saliva after Remaining Adhesive Removal in Orthodontic Patients Using two different methods
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with at least 16 bonded teeth in the mouth
Randomization is done using Random allocation software (RAS) by writing the number of groups and the sample size in the specified field and clicking on the generate random list option gives each sample a code in which The group is placed.
Allocation concealment as Sequentially numbered, opaque, sealed envelopes (SNOSE); is.The sealed envelopes are given to the ward secretary and she registers the patients
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committe of Tabriz University of Medical Sciences
Street address
Department of Orthodontics, School of Dentistry ,Golgasht street ,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5157955359
Approval date
2020-06-01, 1399/03/12
Ethics committee reference number
IR.TBZMED.REC.1399.186
Health conditions studied
1
Description of health condition studied
Evaluation of bisphenol identified in saliva of orthodontic patients after debonding with two methods: Rotary system and ultrasonic scaler