Obesity & OverweightNCT07217756
Impact of Increased Body Mass Index on Adolescent Fixed Orthodontic Treatment. A Prospective Longitudinal Study
An observational study of Obesity & Overweight and Orthodontic Treatment, run by University of Rochester at 1 site in United States.
Trial summary
The goal of this prospective observational study is to assess the influence of increased body mass index (BMI) on various oral health and orthodontic-related parameters in adolescents undergoing orthodontic therapy (OT) with braces. Read more about this study
- Who is it for?
- Ages 12 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight, Orthodontic Treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2022to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adolescent patients undergoing fixed orthodontic therapy at the Eastman Institute for Oral Health, University of Rochester, NY.
Who may be able to join
- adolescents (12-17 years old);
- patients scheduled to undergo comprehensive fixed orthodontic therapy (OT) (for at least 6 months with metal braces/wires) on both dental arches;
- patients with increased BMI (≥25.0 Kg/m2) (test-Group);
- patients with normal BMI [18.5-24.99 (Kg/m2)] (control-Group);
- patients with all 6 mandibular anterior teeth present and mild-to-moderate mandibular crowding (<7.5 mm);
- patients and parents/guardians willing to provide signed assent/permission.
Who cannot join
- self-reported habitual tobacco product users;
- patients with self-reported medical diseases such as hepatic diseases, blood disorders, cardiovascular diseases, HIV, diabetes mellitus, and viral infections;
- patients with craniofacial syndromes and/or cleft lip and palate;
- pregnant and/or lactating females (by self/parent report);
- edentulous individuals;
- patients with active or a history of periodontitis;
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- patients having undergone surgical and/or non-surgical periodontal therapy within the past 6 months;
- patients with physical and/or mental/cognitive disabilities who are decisionally-impaired and not able to consent/assent for themselves;
- patients who reported use of medications such as antibiotics, steroids (inhalers and/or pills), non-steroidal anti-inflammatory drugs, and antimicrobial mouth-rinses within the past 3 months or those who require prophylactic antibiotics prior to dental procedures;
- patients undergoing cancer therapy;
- underweight patients (BMI less than 18.5 Kg/m2);
- patients with oral mucosal lesions such as median rhomboid glossitis and lichen planus;
- patients with clinically visible carious teeth.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dimitrios Michelogiannakis, DDS, MS contact
United States1 site, 1 recruiting
- Recruiting
Eastman Institute for Oral Health, University of Rochester
Rochester, New York, 14620
Dimitrios Michelogiannakis, DDS, MS, 585-275-5012, Dimitrios_Michelogiannakis@URMC.Rochester.edu
Dimitrios Michelogiannakis, DDS, MS
About this study
Official title: Influence of Body Mass Index on Gingival Health, White Spot Lesions, Whole Salivary Proinflammatory Cytokine and Adipokine Profile and Candida and Streptococcus Mutans Carriage Among Adolescents Undergoing Fixed Orthodontic Therapy
The goal of this prospective observational study is to assess the influence of increased body mass index (BMI) on various oral health and orthodontic-related parameters in adolescents undergoing orthodontic therapy (OT) with braces. These parameters include gum inflammation, tooth decalcifications/discolorations, tooth alignment of lower incisors, and various inflammatory and microbiological parameters in the collected saliva and gum fluid of the patients. The primary purpose is to assess if an increased BMI is a risk factor for oral inflammation in adolescents undergoing OT. The main questions it aims to answer are:
- Do patients with an increased BMI undergoing OT demonstrate increased microbial counts in the saliva compared to patients with normal BMI?
- Do patients with increased BMI undergoing OT demonstrate increased gum inflammation, tooth discolorations, and higher levels of inflammatory markers in the saliva and gum fluid samples compared to patients with normal BMI? This study will include 2 study groups (patients with increased BMI-test group, and normal weight patients-control group). The participants will be asked to complete a study questionnaire, which will collect information regarding their demographics, their family socioeconomic and educational status, dietary habits, and oral health-related quality of life. The participants will also receive an oral examination (evaluation of their gum health), and they will have their intraoral photos taken, as well as an impression of their lower teeth (to create dental models). A saliva sample will be obtained by asking patients to passively "drool" in a tube, and a gingival fluid sample will be collected from the gums of the lower anterior teeth using thin paper strips. All these study procedures will be conducted at baseline (T1: before bonding of braces), and at an approximately 6-month follow-up visit (T2). Comparisons of these outcomes will be conducted between the two groups and across timepoints.
- Conditions
- Obesity & Overweight, Orthodontic Treatment
- Keywords
- body mass index, obesity, orthodontic treatment, adolescents, fixed orthodontic appliances
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Increased BMI group (test group) | The increased BMI group will include patients with a BMI>25.0 Kg/m2. | |
| Normal BMI group (control groups) | The normal-BMI group will include patients with a BMI between 18.5 and 24.99 (Kg/m2). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Full-Mouth Bleeding Score (FMBS)
Bleeding on probing (BOP) will be assessed dichotomously (yes/no) at six sites per tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual/palatal, mid-lingual/palatal, and disto-lingual/palatal) using a standardized periodontal probe by trained examiners. The full-mouth bleeding score (FMBS) will be calculated as the percentage of sites that bleed out of the total number of sites examined. Higher percentages indicate greater gingival inflammation.
Measured: Baseline (T1: before bonding of braces) and approximately 6 months follow-up (T2)
Mean Change in White Spot Lesion (WSL) Score (International Caries Detection and Assessment System (ICDAS))
Standardized intraoral and facial photographs will be taken using calibrated camera settings and stored in Dolphin Imaging Software. Each visible tooth surface will be examined for color, texture, and cavitation changes and scored using the International Caries Detection and Assessment System (ICDAS). Code 0 = sound surface; code 2 = visible white spot lesion; codes 3-4 = localized enamel breakdown or dentin shadowing; codes 5-6 = cavitated lesions extending into dentin. Because photos are obtained without air drying, code 1 will be excluded. The average WSL score per participant will be calculated by dividing the total ICDAS score by the number of surfaces assessed. Mean change = score at T2 minus score at T1. Higher scores indicate greater enamel decalcification.
Measured: Baseline (T1: before bonding of braces) and approximately 6 months follow-up (T2)
Mean Change in Salivary Microbial Counts of Candida albicans and Streptococcus mutans
Unstimulated whole saliva will be collected at baseline and follow-up. C. albicans will be cultured on CHROMagar™ Candida and confirmed via germ tube test from three colonies per sample. S. mutans will be cultured on Mitis Salivarius Bacitracin medium and identified by colony morphology. DNA-based microbial identification and oral microbiome sequencing with bioinformatics analysis will also be performed. Microbial counts will be reported per participant as colony-forming units per milliliter (CFU/mL) or relative abundance. Higher values indicate greater microbial load.
Measured: Baseline (T1: before bonding of braces) and approximately 6 months follow-up (T2)
Secondary outcomes (8)
Mean Change in Body Mass Index (BMI)
Height (cm) will be measured using a stadiometer, and weight (kg) with a calibrated digital scale. BMI will be calculated as weight (kg)/height² (m²). Measurements will be taken twice and averaged. Higher BMI indicates greater body mass relative to height.
Measured: Baseline (T1) and approximately 6 months follow-up (T2)
Mean Change in Full-Mouth Plaque Score (FMPS)
Plaque presence will be recorded on four surfaces per tooth (mesial, distal, buccal, lingual/palatal). The FMPS will be calculated as the percentage of surfaces with plaque present out of total surfaces examined. Higher percentages indicate poorer oral hygiene.
Measured: Baseline (T1) and approximately 6 months follow-up (T2)
Mean Change in Percentage of Sites with Probing Depth >3 mm
Probing depth (PD) will be measured at six sites per tooth using a periodontal probe. The percentage of sites with PD greater than 3 mm will be calculated for each participant. Higher percentages indicate more severe periodontal disease.
Measured: Baseline (T1) and approximately 6 months follow-up (T2)
Mean Change in Oral Dryness Score (Challacombe Scale)
Oral dryness will be assessed using the Challacombe Scale, which rates 10 indicators of xerostomia (e.g., lack of saliva pooling, frothy saliva, depapillation, fissured tongue). Scores range from 1 to 10, with 1-3 indicating mild dryness, 4-6 moderate, and 7-10 severe. Higher scores indicate greater dryness.
Measured: Baseline (T1) and approximately 6 months follow-up (T2)
Mean Change in Little's Irregularity Index (Tooth Alignment)
Dental casts made from alginate impressions will be analyzed using a digital caliper (accuracy 0.01 mm). The sum of the linear displacements between the anatomic contact points of the mandibular incisors (five measurements) yields Little's Irregularity Index. Higher values indicate greater misalignment.
Measured: Baseline (T1) and approximately 6 months follow-up (T2)
Mean Change in Salivary Proinflammatory Biomarker Concentrations (IL-1β, IL-6, TNF-α, Leptin, Resistin)
Salivary and gingival crevicular fluid samples will be centrifuged and analyzed using multiplexed magnetic bead assays (Milliplex MAP). Concentrations will be calculated from standard curves. Higher levels indicate greater inflammatory activity.
Measured: Baseline (T1) and approximately 6 months follow-up (T2)
Mean Change in Dietary Habits Score
Participants will complete a standardized questionnaire assessing dietary habits related to oral health and obesity. Responses will be scored to produce a composite dietary habits score; higher scores indicate less healthy dietary patterns.
Measured: Baseline (T1) and approximately 6 months follow-up (T2)
Mean Change in Oral Health-Related Quality of Life (OHIP-14 Total Score)
The Oral Health Impact Profile-14 (OHIP-14) questionnaire will assess functional limitation, pain, and psychological and social impacts of oral health. Scores from 14 items are summed (range 0-56); higher scores indicate poorer oral health-related quality of life.
Measured: Baseline (T1) and approximately 6 months follow-up (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2025
- Study start22 Apr 2022
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- American Association of Orthodontists Foundation
- Responsible party
- Principal investigator, Dimitrios Michelogiannakis, University of Rochester
- Investigators
- Dimitrios Michelogiannakis, DDS, MS, Principal investigator, Eastman Institute for Oral Health, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217756
- Sponsor's protocol ID
- STUDY00005905
- Status last verified
- Oct 2025
- First submitted
- 15 Oct 2025
- Last updated
- 20 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to privacy concerns and the risk of re-identification, even with de-identified datasets. Additionally, the scope of consent obtained from participants during the trial does not include provisions for public sharing of individual-level data.
Publications
Michelogiannakis D, Kassem I, Mendez L, Pahlavani A, Barmak AB, Tsolakis A, Menenakos E, Rossouw PE. Jaw Dimensions, Skeletal Maturation, and Salivary Hormones in Adolescents With Normal and Increased Body Mass Index: A Cross-Sectional Study. Orthod Craniofac Res. 2026 Oct 4. doi: 10.1111/ocr.70191. Online ahead of print.
PubMed 42829963
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Body Mass Index on Gingival Health, White Spot Lesions, Whole Salivary Proinflammatory Cytokine and Adipokine Profile and Candida and Streptococcus Mutans Carriage Among Adolescents Undergoing Fixed Orthodontic Therapy
- ClinicalTrials.gov ID
- NCT07217756
- Acronym / sponsor ID
- STUDY00005905
- Conditions
- Obesity & Overweight, Orthodontic Treatment
- Keywords
- body mass index, obesity, orthodontic treatment, adolescents, fixed orthodontic appliances
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- American Association of Orthodontists Foundation
- Study start
- 22 Apr 2022 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 16 Oct 2025 (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.
The goal of this prospective observational study is to assess the influence of increased body mass index (BMI) on various oral health and orthodontic-related parameters in adolescents undergoing orthodontic therapy (OT) with braces. These parameters include gum inflammation, tooth decalcifications/discolorations, tooth alignment of lower incisors, and various inflammatory and microbiological parameters in the collected saliva and gum fluid of the patients. The primary purpose is to assess if an increased BMI is a risk factor for oral inflammation in adolescents undergoing OT. The main questions it aims to answer are:
- Do patients with an increased BMI undergoing OT demonstrate increased microbial counts in the saliva compared to patients with normal BMI?
- Do patients with increased BMI undergoing OT demonstrate increased gum inflammation, tooth discolorations, and higher levels of inflammatory markers in the saliva and gum fluid samples compared to patients with normal BMI? This study will include 2 study groups (patients with increased BMI-test group, and normal weight patients-control group). The participants will be asked to complete a study questionnaire, which will collect information regarding their demographics, their family socioeconomic and educational status, dietary habits, and oral health-related quality of life. The participants will also receive an oral examination (evaluation of their gum health), and they will have their intraoral photos taken, as well as an impression of their lower teeth (to create dental models). A saliva sample will be obtained by asking patients to passively "drool" in a tube, and a gingival fluid sample will be collected from the gums of the lower anterior teeth using thin paper strips. All these study procedures will be conducted at baseline (T1: before bonding of braces), and at an approximately 6-month follow-up visit (T2). Comparisons of these outcomes will be conducted between the two groups and across timepoints.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Increased BMI group (test group) | – | –The increased BMI group will include patients with a BMI>25.0 Kg/m2. |
| Normal BMI group (control groups) | – | –The normal-BMI group will include patients with a BMI between 18.5 and 24.99 (Kg/m2). |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Adolescent patients undergoing fixed orthodontic therapy at the Eastman Institute for Oral Health, University of Rochester, NY.
Key inclusion criteria (6 listed)
- adolescents (12-17 years old);
- patients scheduled to undergo comprehensive fixed orthodontic therapy (OT) (for at least 6 months with metal braces/wires) on both dental arches;
- patients with increased BMI (≥25.0 Kg/m2) (test-Group);
- patients with normal BMI [18.5-24.99 (Kg/m2)] (control-Group);
- patients with all 6 mandibular anterior teeth present and mild-to-moderate mandibular crowding (<7.5 mm);
Key exclusion criteria (13 listed)
- self-reported habitual tobacco product users;
- patients with self-reported medical diseases such as hepatic diseases, blood disorders, cardiovascular diseases, HIV, diabetes mellitus, and viral infections;
- patients with craniofacial syndromes and/or cleft lip and palate;
- pregnant and/or lactating females (by self/parent report);
- edentulous individuals;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Mean Change in Full-Mouth Bleeding Score (FMBS)
Time frame: Baseline (T1: before bonding of braces) and approximately 6 months follow-up (T2)
Bleeding on probing (BOP) will be assessed dichotomously (yes/no) at six sites per tooth (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual/palatal, mid-lingual/palatal, and disto-lingual/palatal) using a standardized periodontal probe by trained examiners. The full-mouth bleeding score (FMBS) will be calculated as the percentage of sites that bleed out of the total number of sites examined. Higher percentages indicate greater gingival inflammation.
Mean Change in White Spot Lesion (WSL) Score (International Caries Detection and Assessment System (ICDAS))
Time frame: Baseline (T1: before bonding of braces) and approximately 6 months follow-up (T2)
Standardized intraoral and facial photographs will be taken using calibrated camera settings and stored in Dolphin Imaging Software. Each visible tooth surface will be examined for color, texture, and cavitation changes and scored using the International Caries Detection and Assessment System (ICDAS). Code 0 = sound surface; code 2 = visible white spot lesion; codes 3-4 = localized enamel breakdown or dentin shadowing; codes 5-6 = cavitated lesions extending into dentin. Because photos are obtained without air drying, code 1 will be excluded. The average WSL score per participant will be calculated by dividing the total ICDAS score by the number of surfaces assessed. Mean change = score at T2 minus score at T1. Higher scores indicate greater enamel decalcification.
Mean Change in Salivary Microbial Counts of Candida albicans and Streptococcus mutans
Time frame: Baseline (T1: before bonding of braces) and approximately 6 months follow-up (T2)
Unstimulated whole saliva will be collected at baseline and follow-up. C. albicans will be cultured on CHROMagar™ Candida and confirmed via germ tube test from three colonies per sample. S. mutans will be cultured on Mitis Salivarius Bacitracin medium and identified by colony morphology. DNA-based microbial identification and oral microbiome sequencing with bioinformatics analysis will also be performed. Microbial counts will be reported per participant as colony-forming units per milliliter (CFU/mL) or relative abundance. Higher values indicate greater microbial load.
8 secondary outcomes
Mean Change in Body Mass Index (BMI)
Time frame: Baseline (T1) and approximately 6 months follow-up (T2)
Mean Change in Full-Mouth Plaque Score (FMPS)
Time frame: Baseline (T1) and approximately 6 months follow-up (T2)
Mean Change in Percentage of Sites with Probing Depth >3 mm
Time frame: Baseline (T1) and approximately 6 months follow-up (T2)
Mean Change in Oral Dryness Score (Challacombe Scale)
Time frame: Baseline (T1) and approximately 6 months follow-up (T2)
Mean Change in Little's Irregularity Index (Tooth Alignment)
Time frame: Baseline (T1) and approximately 6 months follow-up (T2)
Mean Change in Salivary Proinflammatory Biomarker Concentrations (IL-1β, IL-6, TNF-α, Leptin, Resistin)
Time frame: Baseline (T1) and approximately 6 months follow-up (T2)
Mean Change in Dietary Habits Score
Time frame: Baseline (T1) and approximately 6 months follow-up (T2)
Mean Change in Oral Health-Related Quality of Life (OHIP-14 Total Score)
Time frame: Baseline (T1) and approximately 6 months follow-up (T2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Derived from this study: PubMed 42829963Michelogiannakis D, Kassem I, Mendez L, Pahlavani A, Barmak AB, Tsolakis A, Menenakos E, Rossouw PE. Jaw Dimensions, Skeletal Maturation, and Salivary Hormones in Adolescents With Normal and Increased Body Mass Index: A Cross-Sectional Study. Orthod Craniofac Res. 2026 Oct 4. doi: 10.1111/ocr.70191. Online ahead of print.
- Individual participant dataSharing planned: No. IPD will not be shared due to privacy concerns and the risk of re-identification, even with de-identified datasets. Additionally, the scope of consent obtained from participants during the trial does not include provisions for public sharing of individual-level data.
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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.
Dimitrios Michelogiannakis, DDS, MS contact
Dimitrios Michelogiannakis, DDS, MS principal investigator
Eastman Institute for Oral Health, University of Rochester
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 & Overweight and Orthodontic Treatment, run by University of Rochester at 1 site in United States.
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 6 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 20 Oct 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dimitrios Michelogiannakis, DDS, MS (585-275-5012, Dimitrios_Michelogiannakis@URMC.Rochester.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Full-Mouth Bleeding Score (FMBS) (time frame: Baseline (T1: before bonding of braces) and approximately 6 months follow-up (T2)). The study lists 3 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 NCT07217756, which also lists 1 linked publication.
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 20 Oct 2025.