Evaluation of the Effects of Obesity on Orthodontic Tooth Movement

NCT05988723 | Completed DMC

• 1 other identifier: DHF-21006
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity, Childhood; Orthodontic Treatment

Keywords

Obesity; Orthodontic Treatment; Tooth movement; Biomarkers

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

Study Group (obese patient)

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.

Other: ELISA kits

Control Group (normal patient)

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.

Other: ELISA kits

Interventions

ELISA kits OTHER

Making biochemical measurements with the ELISA kit

Control Group (normal patient); Study Group (obese patient)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Men and women patients aged between 12-18 years who have continued orthodontic treatmens

You may qualify if:

• Body mass index ≥ 95% for obese individuals, body mass index between 16-85% for normal weight individuals,
• Absence of any systemic disease that may affect tooth movement,
• Premolar tooth extraction is required because the patients have Angle Class II malocclusion,
• No history of orthodontic treatment,
• No anti-inflammatory drug use within 1 month before starting the study,
• No signs of gingivitis or a history of periodontal treatment,
• To have good periodontal health,
• The patients are in the permanent dentition period,

You may not qualify if:

• History of previous orthodontic treatment,
• Anti-inflammatory drug use within 1 month before starting the study,
• To have signs of gingivitis or a history of periodontal treatment,
• Individuals with poor periodontal health,
• Individuals in the mixed dentition period,
• Individuals who have smoking or alcohol habits,
• Determined as patient non-compliance.

Sponsors & Collaborators

• Aydin Adnan Menderes University: lead

Study Sites (1)

Aydın Adnan Menderes University Faculty of Dentistry

Aydin, 09100, Turkey (Türkiye)

Location

Related Publications (4)

• 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.

  PMID: 20050744 RESULT

• 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.

  PMID: 26777039 RESULT

• 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.

  PMID: 28471265 RESULT

• 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.

  PMID: 32390057 RESULT

MeSH Terms

Conditions

Pediatric Obesity; Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mine Geçgelen Cesur

  Aydin Adnan Menderes University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: August 14, 2023
• Study Start: April 15, 2021
• Primary Completion: January 16, 2023
• Study Completion: February 13, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)