- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05988723
Evaluation of the Effects of Obesity on Orthodontic Tooth Movement
August 9, 2023 updated by: Mustafa UZUN, Aydin Adnan Menderes University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
36
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Aydın, Turkey, 09100
- Aydın Adnan Menderes University Faculty of Dentistry
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Men and women patients aged between 12-18 years who have continued orthodontic treatmens
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
Making biochemical measurements with the ELISA kit
|
|
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.
|
Making biochemical measurements with the ELISA kit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Leptin, RANKL, OPG and IL-6 ELISA kits
Time Frame: The change in biomarker levels will be measured over a 1-month period.
|
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
Time Frame: It will be examined whether there is a relationship between leptin level and tooth movement speed over a 21-day period.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mine Geçgelen Cesur, Aydin Adnan Menderes University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2021
Primary Completion (Actual)
January 16, 2023
Study Completion (Actual)
February 13, 2023
Study Registration Dates
First Submitted
June 2, 2023
First Submitted That Met QC Criteria
August 9, 2023
First Posted (Actual)
August 14, 2023
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 9, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DHF-21006
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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