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IRCT20210221050435N2 IRCT 2021-10-07 Yazd University of Medical Sciences Level of Metalloproteinase Matrix 8 in Gingival Crevicular Fluid of Mandibular anterior teeth with two types of fixed and removable orthodontic retainers Level of Metalloproteinase Matrix 8 in Gingival Crevicular Fluid of Mandibular anterior teeth with two types of fixed and removable orthodontic retainers 2021-07-01 anticipated 30 Complete https://irct.ir/trial/56547 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. N/A Mandibular Retainer at the end of Orthodontic treatment. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: 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: Start the access period 6 months after publishing the results To whom: Researchers working in academic and scientific institutions and valid scientific research journals Conditions: In order to use the documents of this study for other studies and researches to apply the results Where to obtain: Responsible person in this field: Shiva Abdollahi , email address:sh.abdollahi.dds@gmail.com How to obtain: 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). Comments:
public Hossein agha Aghili
Dental school, The beginning of Dahe Fajr Boulevard, Imam Khomeini St, Yazd
Yazd Iran (Islamic Republic of) 8914881167 +98 35 3625 5881 hosseinaghily@gmail.com Yazd University of Medical Sciences scientific Hossein agha Aghili
Dental school, The beginning of Dahe Fajr Boulevard, Imam Khomeini St, Yazd
Yazd Iran (Islamic Republic of) 8914881167 +98 35 3625 5881 hosseinaghily@gmail.com Yazd University of Medical Sciences Iran (Islamic Republic of) 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. 15 years no limit Both 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. Treatment - Devices Treatment - Devices 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. 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. 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 . 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. 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. 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. 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. Yazd University of Medical Sciences Approved 2021-05-01 Ethic committee of Yazd Shahid sadoughi University of medical science Dahe Fajr Boulevard.Imam Reza Street.Shahid Sadoughi University of medical science.Yazd Yazd Yazd Iran (Islamic Republic of)