Evaluation of the Effects of Obesity on Orthodontic Tooth Movement

Obesity, Childhood Clinical Trial

Official title:

Evaluation of the Effects of Obesity on Orthodontic Tooth Movement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05988723
• Other study ID #: DHF-21006
• Status: Completed
• Start date: April 15, 2021
• Est. completion date: February 13, 2023

Study information

• Verified date: August 2023
• Source: Aydin Adnan Menderes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Among the obese and normal weight patients who applied to Aydın Adnan Menderes University Faculty of Dentistry Department of Orthodontics for orthodontic treatment, those who met the inclusion criteria were selected for the study. Patients with Angle Class II malocclusion who required extraction of the maxillary first premolar tooth were included in the study. Obesity classification, as the World Health Organization (WHO) determines the obesity values in children; BMI values; <5% very thin, 5%-15% underweight, 16-85% normal, 86-95% overweight, and ≥95% obese. Percentile values were calculated with reference to the study "Reference Values for Weight, Height, Head Circumference, and Body Mass Index in Turkish Children" conducted by Neyzi et al. (2015). In our study, individuals with normal weight and without any systemic disease were determined as the control group, and individuals without any systemic disease other than obesity were determined as the study group. Leptin, IL-6, OPG and RANKL levels were measured in gingival sulcus fluid samples taken from the distal gingival groove of obese and healthy individuals who underwent canine distalization. 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 of DOS (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), with the 3shape Trios device and using the OrthoAnalyzer software. The amount of movement of the canine tooth was measured in mm. Before collecting the gingival groove fluid sample, the area was isolated with cotton rolls, and the adjacent teeth and marginal gingival area were air-dried. The Periopaper was then gently placed in the gingival sulci below the gingival margin for 30 seconds. Paper strips were individually sealed in eppendorf tubes and each sample was stored at -80°C until later analysis. Leptin, IL-6, OPG and RANKL levels were examined with Elisa kits from the samples obtained. The planned period for the study was determined as 3 months in total.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 13, 2023
• Est. primary completion date: January 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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,

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Obesity
• Obesity, Childhood
• Orthodontic Treatment
• Pediatric Obesity

Intervention

Other:
• ELISA kits
Making biochemical measurements with the ELISA kit

Locations

Country	Name	City	State
Turkey	Aydin Adnan Menderes University Faculty of Dentistry	Aydin

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.