Protocol summary

Study aim
Comparing the failure rate of the fixed retainer in two types of composites and investigating its relationship with the failure rate of bonding brackets in the same patients.
Design
Clinical trial with two groups, randomized, on 56 patients. MATLAB software will be used for randomization.
Settings and conduct
This RCT will be conducted on 56 orthodontic office patients, immediately after completing their orthodontic treatment. Before starting the work, an informed consent will be obtained. We will use the ready-made American orthodontic retainer as a fixed retainer. We apply one of the two types of composite (Flowable and Gradia) according to a simple randomization process in the mandible of each patient (from canine to canine) for bonding the fixed retainer to the teeth. In each visit, the location of the failure of the fixed retainer will be recorded for each patient. Blinding will be done only in the statistical analysis phase.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Orthodontic patients whose Mandible needs a canine to canine fixed retainer and who have just finished their orthodontic treatment. The age range of patients is between 15 and 25 years. Exclusion criteria: Patients with gastrointestinal reflux, patients whose mandibular anterior teeth have undergone RCT and the lingual surface of the tooth has been restored, patients whose saliva level is too low. Note: Patients who have plaque or stain on the lingual surface of their mandibular anterior teeth will be included in the study, provided that they are referred for SRP one month before the de-bonding of brackets.
Intervention groups
Group 1- Gradia composite Group 2- Flowable GC Composite
Main outcome variables
1- The rate and location of failure of the fixed retainer 2- Bracket bonding failure rate 3- Determining clinical working time with two types of composite

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230430058031N1
Registration date: 2023-11-04, 1402/08/13
Registration timing: prospective

Last update: 2023-11-04, 1402/08/13
Update count: 0
Registration date
2023-11-04, 1402/08/13
Registrant information
Name
Arsalan Khorram
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3331 5033
Email address
khorrama@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-28, 1402/09/07
Expected recruitment end date
2023-12-08, 1402/09/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of mandibular canine to canine fixed retainer failure rate bonded by two types of adhesives (GC flowable composite and GC Gradia composite) in orthodontic patients and investigating its relationship with de-bonding rate of brackets: RCT
Public title
Fixed retainer failure rate and investigating its relationship with de-bonding rate of brackets
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The Mandible needs a canine to canine fixed retainer and patients just finished their orthodontic treatment. The age range of patients is between 15 and 25 years.
Exclusion criteria:
Patients with gastrointestinal reflux Patients whose mandibular anterior teeth underwent RCT and the lingual surface of the tooth was restored Patients with too little saliva and xerostomia
Age
From 15 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 56
More than 1 sample in each individual
Number of samples in each individual: 6
Considering Alpha=0.05 and Beta=0.2, proportion in group 1(%)=30, proportion in group 2(%)=45 with allocation 1/1 and 56 patients, 6 teeth per patient will be studied. As a result, 336 samples have been considered in 6 months of follow-up. (Calculated using MedCalc software.)
Randomization (investigator's opinion)
Randomized
Randomization description
There are 70 fixed orthodontic patients whose orthodontic treatment has been completed in an ideal way according to the orthodontist and who are ready to enter the study. Considering the sample size that will be 56 patients, out of 70 people, 56 people should be selected with the same probability of being selected (uniform distribution and individual randomization unit) (simple randomization sampling was used and how Creating a random sequence = using RAND function of MATLAB software.) With the sealed envelope tool, we will distribute 70 envelopes, 56 envelopes containing paper with the words "entry into the study" and 14 envelopes containing paper with the word "not entering the study" among 70 patients by the team of office secretaries. Among these 56 selected people, again with the sealed envelope tool, we divide the patients into two groups (first group: with Flowable composite and second group: with Gradia composite) with 1/1 allocation by simple randomization method. (simple randomization is used and how to make a random sequence = using RAND function of MATLAB software) For allocation concealment, we use a team of office secretaries who have no knowledge of the writings inside each of the opaque sealed envelopes written by us.
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 committee of Tabriz University of Medical Sciences
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2023-07-17, 1402/04/26
Ethics committee reference number
IR.TBZMED.REC.1402.310

Health conditions studied

1

Description of health condition studied
Determining the bonding failure rate in two types of GC Flowable composite and GC Gradia composite.
ICD-10 code
Z46.4
ICD-10 code description
Encounter for fitting and adjustment of orthodontic device

2

Description of health condition studied
Comparing the failure rate of bonding brackets with the failure rate of fixed retainer bonding in the same patients.
ICD-10 code
Z46.4
ICD-10 code description
Encounter for fitting and adjustment of orthodontic device

3

Description of health condition studied
Determining clinical working time with two types of composite
ICD-10 code
Z46.4
ICD-10 code description
Encounter for fitting and adjustment of orthodontic device

Primary outcomes

1

Description
The rate and location of failure of the fixed retainer
Timepoint
One-month,three-month,six-month follow-ups
Method of measurement
Observational

2

Description
Bonding failure rate of brackets
Timepoint
During the entire period of orthodontic treatment
Method of measurement
Observational

3

Description
Determining clinical working time with two types of composite
Timepoint
While working with composites
Method of measurement
stopwatch (observational)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: GC Gradia composite, Gradia direct anterior, Light cured composite restorative A1 4g(2.7 ml), Tokyo, Japan, Gradia composite is placed on the cingulum by the composite pen so that it covers approximately one millimeter of the wire and covers approximately half of the mesiodistal width of the tooth.
Category
Treatment - Devices

2

Description
Intervention group: GC Flowable composite, GC Ortho connect Flow, Light cured orthodontic adhesive 2.7g(2.0 ml),Tokyo, Japan, The flowable composite is placed on the tooth with the help of a special Flowable GC composite tip.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Dr. Ravadgar Orthodontic office
Full name of responsible person
Dr. Mehdi Ravadgar
Street address
Unit 1- 6th floor-Iran Clinic-next to the Gostaresh hotel - Abrasan Crossroads
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3325 0674
Email
m_ravadgar@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Tabriz University of Medical Sciences, University Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Fax
+98 41 3334 6977
Email
dent.fac@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Ravadgar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthodontist
Street address
Tabriz University of Medical Sciences, University Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3325 0674
Email
m_ravadgar@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehdi Ravadgar
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Orthodontist
Street address
Tabriz University of Medical Sciences, University Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3325 0674
Email
m_ravadgar@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Arsalan Khorram
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No 33, Lida, Shahriar, Valiasr
City
Tabriz
Province
East Azarbaijan
Postal code
5157844583
Phone
+98 41 3331 5033
Fax
Email
khorrama@tbzmed.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
Loading...