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A comparative assessment of Streptococcus mutans population between conventional composites and composites containing bioactive glass in fixed orthodontic patients

Protocol summary

Study aim
Comparison of Streptococcus mutans bacteria accumulation around orthodontic brackets between two groups of conventional composite and composite containing BAG in fixed orthodontic patients
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, on 24 patients with 2 samples per patient. For randomization, control and test sides are selected by coin toss.
Settings and conduct
This study will be conducted in the orthodontic department of the Dentistry Faculty of Kerman University of Medical Sciences. In each patient, the control and test sides are randomly selected by tossing a coin. The operator who performs the bracket bonding is blinded to the study, so they do 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 their reports using the study coding system.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 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. Exclusion criteria: Patients with systemic diseases; Patients with drug-related xerostomia; Patients with periodontal diseases; Patients whose upper second premolar bracket is detached during treatment.
Intervention groups
Intervention group: Bracket bonding using composite containing BAG (TransbondXT adhesive containing BAG) Control group: Bracket bonding using conventional composite (TransbondXT adhesive)
Main outcome variables
Accumulation of Streptococcus mutans around the brackets of upper premolar teeth

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220912055949N1
Registration date: 2023-01-30, 1401/11/10
Registration timing: prospective

Last update: 2023-01-30, 1401/11/10
Update count: 0
Registration date
2023-01-30, 1401/11/10
Registrant information
Name
Sahar Zolfigol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 9021
Email address
s_zolfigol@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-20, 1401/12/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative assessment of Streptococcus mutans population between conventional composites and composites containing bioactive glass in fixed orthodontic patients
Public title
A comparative assessment of Streptococcus mutans population between conventional composites and composites containing bioactive glass in fixed orthodontic patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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.
Exclusion criteria:
Patients with systemic diseases Patients with drug-related xerostomia Patients with periodontal diseases Patients whose upper second premolar bracket is detached during treatment.
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 24
More than 1 sample in each individual
Number of samples in each individual: 2
In each patient in the upper jaw and premolar region, 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.
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Kerman University of Medical Sciences, Haft Bagh Alavi axis, Kerman
City
Kerman
Province
Kerman
Postal code
7616913555
Approval date
2022-11-07, 1401/08/16
Ethics committee reference number
IR.KMU.REC.1401.362

Health conditions studied

1

Description of health condition studied
Streptococcus mutans accumulation around dental brackets
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Composite containing bioactive glass
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
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.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Bracket bonding using composite containing BAG (TransbondXT adhesive containing BAG)
Category
Treatment - Other

2

Description
Control group: Bracket bonding using conventional composite (TransbondXT adhesive)
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Dentistry Faculty of Kerman University of Medical Sciences
Full name of responsible person
Sahar Zolfigol
Street address
Dentistry Faculty of Kerman University Medical Sciences, Shafa St., Jomhouri Blvd.
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
s_zolfigol@kmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Moluk Torabi Parizi
Street address
Dentistry Faculty of Kerman University Medical Sciences, Shafa St., Jomhouri Blvd.
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
m_torabi@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Sahar Zolfigol
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dentistry Faculty of Kerman University Medical Sciences, Shafa St., Jomhouri Blvd.
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
s_zolfigol@kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Sahar Zolfigol
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dentistry Faculty of Kerman University Medical Sciences, Shafa St., Jomhouri Blvd.
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
s_zolfigol@kmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Sahar Zolfigol
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Dentistry Faculty of Kerman University Medical Sciences, Shafa St., Jomhouri Blvd.
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
s_zolfigol@kmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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