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IRCT20220912055949N1 IRCT 2023-01-30 Kerman University of Medical Sciences A comparative assessment of Streptococcus mutans population between conventional composites and composites containing bioactive glass in fixed orthodontic patients A comparative assessment of Streptococcus mutans population between conventional composites and composites containing bioactive glass in fixed orthodontic patients 2023-02-20 anticipated 24 Complete https://irct.ir/trial/65869 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomization, in each patient, both control and test sides are randomly selected by tossing a coin. (allocation ratio 1:1) To prepare the tooth enamel, 37% phosphoric acid gel is placed on the tooth enamel for 30 seconds and then washed for 30 seconds and dried for 20 seconds. On the control side, after preparing the tooth enamel, a thin layer of liquid primer (Transbond XT) is placed on the surface of the tooth and the adhesive (TransbondXT) is immediately used to bond the bracket. On the test side, TransbondXt containing BAG is used as an adhesive, Blinding description: The operator who performs the bracket bonding is blinded to the study, so he does not know which side the brackets are bonded with which composite. At this stage, a code is given to each side of the participants' mouth. Patients are also blinded to the study. For microbial investigation, sampling is done by another operator who is unaware of the side where the brackets are bonded with each composite. This operator presents his reports using the study coding system. N/A Condition 1: Streptococcus mutans accumulation around dental brackets. Condition 2: Composite containing bioactive glass. Intervention 1: Intervention group: Bracket bonding using composite containing BAG (TransbondXT adhesive containing BAG). Intervention 2: Control group: Bracket bonding using conventional composite (TransbondXT adhesive). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Sahar Zolfigol
Dentistry Faculty of Kerman University Medical Sciences, Shafa St., Jomhouri Blvd.
Kerman Iran (Islamic Republic of) 7618759689 +98 34 3211 9021 s_zolfigol@kmu.ac.ir Kerman University of Medical Sciences scientific Sahar Zolfigol
Dentistry Faculty of Kerman University Medical Sciences, Shafa St., Jomhouri Blvd.
Kerman Iran (Islamic Republic of) 7618759689 +98 34 3211 9021 s_zolfigol@kmu.ac.ir Kerman University of Medical Sciences Iran (Islamic Republic of) Patients who need fixed orthodontic treatment. Patients whose upper second premolar teeth are without macroscopic cracks, caries or enamel hypoplasia. Patients who do not have any dental caries. 18 years 30 years Both Patients with systemic diseases Patients with drug-related xerostomia Patients with periodontal diseases Patients whose upper second premolar bracket is detached during treatment. Treatment - Other Treatment - Other Intervention group: Bracket bonding using composite containing BAG (TransbondXT adhesive containing BAG) Control group: Bracket bonding using conventional composite (TransbondXT adhesive) Accumulation of Streptococcus mutans around the brackets of upper premolar teeth. Timepoint: At the beginning of the study (before the start of the intervention), 3 and 6 months after the bonding of brackets. Method of measurement: Sampling is done using a sterile swab. The swab is transferred to a micro tube containing 200 microliters of sterile phosphate buffer. The micro tube is immediately transferred to the microbiology laboratory at a temperature of 4 degrees Celsius. 100 microliters of each sample is cultured on Mitis salivarius agar culture medium. In this study, glycosyl transferase-1 (gtfb-1) gene sequence will be used and with the help of this technique, the amount of Streptococcus mutans accumulation will be measured and compared. Kerman University of Medical Sciences Approved 2022-11-07 Ethics committee of Kerman University of Medical Sciences Kerman University of Medical Sciences, Haft Bagh Alavi axis, Kerman Kerman Kerman Iran (Islamic Republic of)