Level of Metalloproteinase Matrix 8 in Gingival Crevicular Fluid of Mandibular anterior teeth with two types of fixed and removable orthodontic retainers
Determination of mean metalloproteinase matrix 8 (in pg) in mandibular anterior teeth in ESSIX and bonded retainers
Design
Clinical trial, two parallel groups, double-blind, randomized to 30 patients, randomization by Random allocation software.
Settings and conduct
The study is performed at Shahid Sadoughi Dental School in Yazd. ESSIX retainer is bandaged for each patient in a session and in the upper jaw, and according to the group in which they are located, in the lower jaw, Retainer wire Hilgers Bond A Braid or ESSIX retainer (by Vacuum thermoforming machine is placed. The gingival fluid of these patients will be sampled on the day of debonding, 30 days later and 90 days later. In this study, the statistical consultant and the head of the laboratory become blind
Participants/Inclusion and exclusion criteria
Inclusion: 1-Patients have been treated with the 022 System and their treatment has been completed with satisfactory correction of malocclusion and appropriate dental alingment.2-The Patient's condition is favorable in terms of general health.3-Absence of Craniofacial Syndromes and Facial Clefts
4-Absence of severe and uncontrolled Caries
5-The Patient should have good oral hygiene and be Periodontally normal.
6-The Patient should have all the anterior Mandibular teeth and the teeth should be of normal shape and size
Non inclusion:1-Lack of Patient cooperation to refer 2-Observe poor Periodontal status during the study3-Break and not using the retainer 4-Specific conditions of COVID 19 infection that prevent the Patient from visiting.
Intervention groups
The first intervention group (15 patients) who have ESSIX at the end of treatment and the second intervention group (15 patients) who have a banded retainer at the end of treatment.
Main outcome variables
Metalloproteinase matrix level 8 after orthodontic debonding immediately after debonding, 30 days and 90 days after debonding
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210221050435N2
Registration date:2021-10-07, 1400/07/15
Registration timing:registered_while_recruiting
Last update:2021-10-07, 1400/07/15
Update count:0
Registration date
2021-10-07, 1400/07/15
Registrant information
Name
Hossein Aghili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 1785
Email address
hosseinaghily@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-01, 1400/04/10
Expected recruitment end date
2021-11-22, 1400/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Level of Metalloproteinase Matrix 8 in Gingival Crevicular Fluid of Mandibular anterior teeth with two types of fixed and removable orthodontic retainers
Public title
Level of Metalloproteinase Matrix 8 in Gingival Crevicular Fluid of Mandibular anterior teeth with two types of fixed and removable orthodontic retainers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients have been treated with the 022 System and their treatment has been completed with satisfactory correction of malocclusion and appropriate dental alingment.
The Patient's condition is favorable in terms of general health.
Absence of Craniofacial Syndromes and Facial Clefts
Absence of severe and uncontrolled Caries
The Patient should have good oral hygiene and be Periodontally normal.
The Patient should have all the anterior Mandibular teeth and the teeth should be of normal shape and size.
Exclusion criteria:
Lack of Patient cooperation to refer
Observe poor Periodontal status during the study
Break and not using the retainer
Specific conditions of COVID 19 infection that prevent the Patient from visiting.
Age
From 15 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
First, using Random allocation software version 1.0 under Windows ,we generate a random sequence using a simple random allocation method. In this table, it is specified from 1 to 22 and each number is assigned to an intervention group (A or B). The first eligible patient is assigned number 1, the second patient is assigned number 2 and so on up to 22 patients. In order to blind the random allocation of clients by a third person who is unaware of the interventions, they are placed in intervention groups (A or B) by this table.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the Patients and the researcher (who is responsible for sampling of Patients) are aware of the type of retainer in the Mandible. But the person in charge of data collection, the statistician consult who is in charge of data analysis, and the person in charge of the laboratory who will eventually analyze the samples are blinded because the information and samples of patients in all the mentioned steps will be identified only by random numbers.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Yazd Shahid sadoughi University of medical science
Street address
Dahe Fajr Boulevard.Imam Reza Street.Shahid Sadoughi University of medical science.Yazd
City
Yazd
Province
Yazd
Postal code
8914881167
Approval date
2021-05-01, 1400/02/11
Ethics committee reference number
IR.SSU.REC.1400.013
Health conditions studied
1
Description of health condition studied
Mandibular Retainer at the end of Orthodontic treatment
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Level of Matrix Metalloproteinase 8 after Orthodontic debonding
Timepoint
Immediately after debonding, 30 days after debonding, 90 days after debonding
Method of measurement
Sampling of the gingival crevice fluid will be done and then the amount of Matrix Metalloproteinase 8 enzyme will be determined with the kit related to the this enzyme .
Secondary outcomes
1
Description
Little irregularity index
Timepoint
Day of debonding, 30 days after debonding, 90 days after debonding
Method of measurement
Evaluation from cast taken from the patient on the days of measurement
2
Description
Overjet
Timepoint
Day of debonding, 30 days after debonding, 90 days after debonding
Method of measurement
Examination in the patient's mouth on the days of measurement
3
Description
Overbite
Timepoint
Day of debonding, 30 days after debonding, 90 days after debonding
Method of measurement
Examination in the patient's mouth on the days of measurement
4
Description
Bleeding after gingival probing
Timepoint
Day of debonding, 30 days after debonding, 90 days after debonding
Method of measurement
Examination in the patient's mouth on the days of measurement
Intervention groups
1
Description
Intervention group: After setting the appointment, for each patient in a session, the ESSIX retainer will be placed in the upper jaw, and according to the group in which they are placed, the banded retainer(Retainer wire Hilgers Bond-A-Braid :Stainless steel, 8-strand, dead soft ) will be placed in the lower jaw.At the time of Debonding, the patient is molded and a cast is prepared for him. To make the retainer, after debonding, the patient is molded using alginate.In the retainer bonding session, first the lingual surface of the mandibular incisor teeth is rinsed with water and gently dried with air . Two pieces of dental floss pass through the contact between the lateral and canine on both sides and the retainer is placed in place. Flossing passes over the retainer and the retainer adapts to the lingual surface of the teeth by applying some force.The lingual surface of these teeth is etched with 37% phosphoric acid and rinsed, and then the retainer is bonded to the lingual surface using TRANSBOND composite.The gingival fluid of these patients will be sampled on the day of debonding, 30 days later and 90 days later.
Category
Treatment - Devices
2
Description
Intervention group: After setting the appointment, for each patient in a session, the ESSIX retainer is placed in the upper jaw, and according to the group in which they are placed, the ESSIX retainer is placed in the lower jaw. ESSIX retainer (1 mm thick) by Vacuum ،Thermoforming Machine is also made on the cast prepared by the patient after debanding.The gingival fluid of these patients will be sampled on the day of debonding, 30 days later and 90 days later.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Orthodontics, School of Dentistry, Shahid Sadoughi University of Medical Sciences, Yaz
Full name of responsible person
Hossein agha Aghili
Street address
The beginning of Deh Fajr Boulevard, Imam Khomeini St
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Email
hosseinaghily@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Dr.Masoud Mirzaei
Street address
The headquarters of Shahid Sadoughi University of Medical Sciences and Health Services, Bahonar Square, Yazd
City
Yazd
Province
Yazd
Postal code
Phone
+98 35 3726 3733
Fax
+98 35 3726 3733
Email
dvc.research@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Hossein agha Aghili
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental school, The beginning of Dahe Fajr Boulevard, Imam Khomeini St, Yazd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Fax
+98 35 3625 0344
Email
hosseinaghily@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Hossein agha Aghili
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental school, The beginning of Dahe Fajr Boulevard, Imam Khomeini St, Yazd
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3625 5881
Fax
+98 35 3625 0344
Email
hosseinaghily@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Shiva abdollahi
Position
Orthodintic Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid sadoughi university of medical sciences .school of dentistry.orthodontics dept
City
Yazd
Province
Yazd
Postal code
8914881167
Phone
+98 35 3824 1785
Email
sh.abdollahi.dds@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
After unidentifying individuals, it is possible to share all values of the metalloproteinase matrix and the irrigularity index and overjet and overbite of patients in both treatment groups.
When the data will become available and for how long
Start the access period 6 months after publishing the results
To whom data/document is available
Researchers working in academic and scientific institutions and valid scientific research journals
Under which criteria data/document could be used
In order to use the documents of this study for other studies and researches to apply the results
From where data/document is obtainable
Responsible person in this field: Shiva Abdollahi , email address:sh.abdollahi.dds@gmail.com
What processes are involved for a request to access data/document
The applicant can send his request to the above-mentioned email address with his introduction and the reason for the request and receive the information as soon as possible (finally within 7-10 days).