NCT05988723|CompletedDMC
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Sponsor study identifier
observational
36
1 country
1
Study Start
April 15, 2021
Actual (reported)Primary Completion
January 16, 2023
Actual (reported)Study Completion
February 13, 2023
Actual (reported)In this study, bone remodeling in the gingival crevicular fluid was evaluated biochemically during canine distalization in obese individuals and compared with normal weight individuals. At the same time, the speed of tooth movement was measured in obese individuals and compared with normal weight individuals.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 13, 2023
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 15, 2021
Actual (reported)January 16, 2023
Actual (reported)February 13, 2023
Actual (reported)June 2, 2023
Actual (reported)August 14, 2023
Actual (reported)Leptin, RANKL, OPG and IL-6 ELISA kits
ELISA kits were used to measure the biomarker level in gingival crevicular fluid samples taken from the patient.
The change in biomarker levels will be measured over a 1-month period.
Correlation between leptin level and tooth movement speed
3D intraoral scanner and leptin elisa kit will be used
It will be examined whether there is a relationship between leptin level and tooth movement speed over a 21-day period.
Leptin, IL-6, OPG, RANKL levels were measured in samples taken from the distal gingival groove of the canine teeth of obese individuals. Roth metal brackets and tubes with 0.022 inch slots were used for the fixed orthodontic treatment of the patients. After leveling the teeth of the patients with arch wires, it was waited for 2 months in 19x25 stainless steel arch wire and then 150 gr distalization force was applied. DOS samples were taken from the distal gingival groove of teeth on day 7 (T2), day 14 (T3) and day 21 (T4), just before distalization force was applied (T0), 24 hours after force was applied (T1). In order to determine the speed of tooth movement, the patient's mouth was scanned on the days when DOS was taken (T0,T1,T2,T3,T4) and in addition to these days, on the 28th day (T5) and at the end of the 3rd month (T6), and the amount of movement of the canine tooth was measured in mm. Leptin, IL-6, OPG, RANKL levels were examined with Elisa kits from the samples obtained.
Leptin, IL-6, OPG, RANKL levels were measured in samples taken from the distal gingival groove of the canine teeth of normal weight individuals.Roth metal brackets and tubes with 0.022 inch slots were used for the fixed orthodontic treatment of the patients.After leveling the teeth of the patients with arch wires, it was waited for 2 months in 19x25 stainless steel arch wire and then 150 gr distalization force was applied.DOS samples were taken from the distal gingival groove of teeth on day 7 (T2), day 14 (T3) and day 21 (T4), just before distalization force was applied (T0), 24 hours after force was applied (T1). In order to determine the speed of tooth movement, the patient's mouth was scanned on the days when DOS was taken (T0,T1,T2,T3,T4) and in addition to these days, on the 28th day (T5) and at the end of the 3rd month (T6), and the amount of movement of the canine tooth was measured in mm. Leptin, IL-6, OPG, RANKL levels were examined with Elisa kits from the samples obtained.
Making biochemical measurements with the ELISA kit
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Men and women patients aged between 12-18 years who have continued orthodontic treatmens
Aydın Adnan Menderes University Faculty of Dentistry
Aydin, 09100, Turkey (Türkiye)
Dilsiz A, Kilic N, Aydin T, Ates FN, Zihni M, Bulut C. Leptin levels in gingival crevicular fluid during orthodontic tooth movement. Angle Orthod. 2010 May;80(3):504-8. doi: 10.2319/072109-402.1.
Neyzi O, Bundak R, Gokcay G, Gunoz H, Furman A, Darendeliler F, Bas F. Reference Values for Weight, Height, Head Circumference, and Body Mass Index in Turkish Children. J Clin Res Pediatr Endocrinol. 2015 Dec;7(4):280-93. doi: 10.4274/jcrpe.2183.
Mine Geçgelen Cesur
Aydin Adnan Menderes University
36 participants (actual enrollment reported by the registry).
First Submitted
June 2, 2023
First Posted
August 14, 2023
Study Start
April 15, 2021
Actual (reported)The Effect of Exercise With AR Glasses on Metabolic Parameters and Anthropometric Measurements in Obese Adolescents
Contact the study team to confirm eligibility.
Jayachandran T, Srinivasan B, Padmanabhan S. Salivary leptin levels in normal weight and overweight individuals and their correlation with orthodontic tooth movement. Angle Orthod. 2017 Sep;87(5):739-744. doi: 10.2319/120216-869.1. Epub 2017 May 4.
Saloom HF, Boustan R, Seehra J, Papageorgiou SN, Carpenter GH, Cobourne MT. The impact of obesity on orthodontic treatment outcome in adolescents: a prospective clinical cohort study. Eur J Orthod. 2021 Apr 3;43(2):165-172. doi: 10.1093/ejo/cjaa032.
Primary Completion
January 16, 2023
Actual (reported)Study Completion
February 13, 2023
Actual (reported)Last Updated
August 14, 2023
Record last verified: 2023-08
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Source: ClinicalTrials.gov.
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