Obesity, ChildhoodNCT05988723
Evaluation of the Effects of Obesity on Orthodontic Tooth Movement
An observational study of Obesity, Childhood and Orthodontic Treatment, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood, Orthodontic Treatment
- What is being tested?
- ELISA kits
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Apr 2021to 13 Feb 2023
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Men and women patients aged between 12-18 years who have continued orthodontic treatmens
Who may be able to join
- 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,
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydın Adnan Menderes University Faculty of Dentistry
Aydin, 09100
About this study
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.
Read the 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.
- Conditions
- Obesity, Childhood, Orthodontic Treatment
- Being tested
- ELISA kits
- Keywords
- Obesity, Orthodontic Treatment, Tooth movement, Biomarkers
- Medical subject headings
- Pediatric Obesity, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISA kitsOther
Making biochemical measurements with the ELISA kit
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: ELISA kits |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: It will be examined whether there is a relationship between leptin level and tooth movement speed over a 21-day period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start15 Apr 2021
- Primary completion16 Jan 2023
- Study completion13 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obesity, ChildhoodStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa UZUN, Aydin Adnan Menderes University
- Investigators
- Mine Geçgelen Cesur, Study director, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988723
- Sponsor's protocol ID
- DHF-21006
- Status last verified
- Aug 2023
- First submitted
- 2 Jun 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 20050744Neyzi 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.
PubMed 26777039Jayachandran 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.
PubMed 28471265Saloom 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.
PubMed 32390057
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Obesity on Orthodontic Tooth Movement
- ClinicalTrials.gov ID
- NCT05988723
- Acronym / sponsor ID
- DHF-21006
- Conditions
- Obesity, Childhood, Orthodontic Treatment
- Keywords
- Obesity, Orthodontic Treatment, Tooth movement, Biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 16 Jan 2023 (actual)
- Study completion
- 13 Feb 2023 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group (obese patient) | – | Other: ELISA kitsLeptin, 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. |
| Control Group (normal patient) | – | Other: ELISA kitsLeptin, 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Men and women patients aged between 12-18 years who have continued orthodontic treatmens
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELISA kitsMaking biochemical measurements with the ELISA kit | Other | Control Group (normal patient), Study Group (obese patient) |
Primary outcome
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Results publication: PubMed 20050744Dilsiz 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.
- Results publication: PubMed 26777039Neyzi 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.
- Results publication: PubMed 28471265Jayachandran 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.
- Results publication: PubMed 32390057Saloom 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mine Geçgelen Cesur study director
Aydin Adnan Menderes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Childhood and Orthodontic Treatment, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leptin, RANKL, OPG and IL-6 ELISA kits (time frame: The change in biomarker levels will be measured over a 1-month period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05988723, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.