ObesityNCT07478653
MODERN-Dental: Pediatric Obesity, Cardiometabolic Risks, And Periodontal Disease
A study testing Dental Cleaning and Oral Hygiene Instruction (OHI) and Oral Hygiene Instruction (OHI) in people with Obesity and Dental Care for Children, run by Oelisoa Andriankaja at 1 site in United States.
Trial summary
The goal of this clinical trial is to assess whether adjunctive dental cleaning can enhance the effects of semaglutide in children with obesity. The main question[s] it aims to answer [is/are]: if dental cleaning will improve both oral health and metabolic outcomes beyond the effects of semaglutide alone. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Obesity, Dental Care for Children
- What is being tested?
- Dental Cleaning and Oral Hygiene Instruction (OHI) and Oral Hygiene Instruction (OHI)
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2026to 31 Jul 2028
- Phase
- Interventional
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- participants from the ongoing Mitigation of Cardiovascular Disease Risks in Children with Extreme Obesity (MODERN) study (NCT06967389)
- Class 2 or 3 obesity (BMI =120% of the 95th percentile for age and sex)
Who cannot join
- Same exclusion as parent study.
- Planning to receive or complete dental services during the 12-month course of the study
- Ongoing orthodontic treatment
- Use of any anti-inflammatory medication (other than steroids) within 1 month prior to enrollment
- Currently taking medications that could influence the characteristics or response to periodontal treatment (e.g., use of immunosuppressants or steroids)
- Local or systemic antibiotic use within 15 days prior to enrollment or for >10 days within the past 3 months
- History of bleeding disorders
- Professional dental prophylaxis or non-surgical periodontal therapy within the past 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shaddox contact
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40506
About this study
Official title: MODERN-Dental: Pediatric Obesity, Cardiometabolic Risks, And Periodontal Disease: Effects Of Semaglutide Treatment
The goal of this clinical trial is to assess whether adjunctive dental cleaning can enhance the effects of semaglutide in children with obesity. The main question[s] it aims to answer [is/are]:
if dental cleaning will improve both oral health and metabolic outcomes beyond the effects of semaglutide alone.
Participants will receive either dental cleaning and oral hygiene instruction or oral hygiene instruction alone.
Read the detailed description
Parent study NCT06967389
- Conditions
- Obesity, Dental Care for Children
- Being tested
- Dental Cleaning and Oral Hygiene Instruction (OHI), Oral Hygiene Instruction (OHI)
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental Cleaning and Oral Hygiene Instruction (OHI)Procedure or surgery
Participants receive dental cleaning and oral hygiene instruction (OHI) and oral health assessments at baseline (prior to initiating weight-loss medication), 6 months (±2 weeks), and 12 months (±1 month) post-enrollment.
Oral Hygiene Instruction (OHI)Behavioural
Participants will receive standard oral health care, including instructions on how to care for their teeth (OHI). Dental cleaning provided at 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Dental cleaning and Oral Hygiene Instruction (OHI) | Experimental | Not described Receives: Procedure: Dental Cleaning and Oral Hygiene Instruction (OHI) |
| Oral Hygiene Instruction (OHI) only | Active comparator | Not described Receives: Behavioral: Oral Hygiene Instruction (OHI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gingival index
Based on visual assessment and gentle probing of the marginal periodontal tissues. Scored on a 0-3 scale and the higher score means increased inflammation.
Measured: Baseline, 6 months, 12 months
Change in probing depth
Measuring the pocket depth at six sites per tooth (in millimeters) using a UNC-15 periodontal probe.
Measured: Baseline, 6 months, 12 months
Change in BOP (Bleeding on probing)
Presence or absence of bleeding upon probing recorded at six sites per tooth.
Measured: Baseline, 6 months, 12 months
Change in Plaque Index
Measured using a plaque score (0-3) at six specific Ramfjord teeth
Measured: Baseline, 6 months, 12 months
Change in Clinical Attachment Level (CAL)
Calculated as PD (Pocket Depth) + GM (Gingival Margin) for each site.
Measured: Baseline, 6 months, 12 months
Change in Gingival Margin Position (GM)
Recorded at six sites per tooth (in millimeters) using a UNC-15 periodontal probe.
Measured: Baseline, 6 months, 12 months
Number of participants with Supragingival and Subgingival Calculus
Recorded as present or absent, generalized or localized when visible or detected upon probing.
Measured: Baseline, 6 months, 12 months
Change in Gingival Crevicular Fluid (GCF)
Up to six samples per participant using Periopaper strips at mesiobuccal interproximal sites.
Measured: Baseline, 6 months, 12 months
Change in Bacterial Subgingival Biofilm
Collected from the same sites as GCF using sterile endodontic paper points.
Measured: Baseline, 6 months, 12 months
Change in levels of Interleukin-1 beta (IL-1β)
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Measured: Baseline, 6 months, 12 months
Change in levels of Tumor Necrosis Factor-alpha
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Measured: Baseline, 6 months, 12 months
Change in levels of Interleukin-6 (IL-6)
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Measured: Baseline, 6 months, 12 months
Change in levels of C-reactive protein (CRP)
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Measured: Baseline, 6 months, 12 months
Change in levels of Soluble intercellular adhesion molecule-1 (sICAM-1)
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Measured: Baseline, 6 months, 12 months
Change in levels of Soluble vascular cell adhesion molecule-1 (sVCAM-1)
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Measured: Baseline, 6 months, 12 months
Change in levels of endocan
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Measured: Baseline, 6 months, 12 months
Change in levels of Vascular Endothelial Growth Factor A (VEGF-A)
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Measured: Baseline, 6 months, 12 months
Change in Oral Microbiome
DNA sequencing. Saliva will be collected.
Measured: Baseline, 6 months, 12 months
Change in active oral microbiome (RNA sequencing)
RNA sequencing. Saliva will be collected.
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start31 Aug 2026
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oelisoa Andriankaja
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Oelisoa Andriankaja, University of Kentucky
- Investigators
- Oelisoa Andriankaja, DDS, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478653
- Sponsor's protocol ID
- 108598
- Status last verified
- Oct 2026
- First submitted
- 12 Mar 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MODERN-Dental: Pediatric Obesity, Cardiometabolic Risks, And Periodontal Disease: Effects Of Semaglutide Treatment
- ClinicalTrials.gov ID
- NCT07478653
- Acronym / sponsor ID
- 108598
- Conditions
- Obesity, Dental Care for Children
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Oelisoa AndriankajaUniversity, hospital or other
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 17 Mar 2026 (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 clinical trial is to assess whether adjunctive dental cleaning can enhance the effects of semaglutide in children with obesity. The main question[s] it aims to answer [is/are]:
if dental cleaning will improve both oral health and metabolic outcomes beyond the effects of semaglutide alone.
Participants will receive either dental cleaning and oral hygiene instruction or oral hygiene instruction alone.
Detailed description
Parent study NCT06967389
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dental cleaning and Oral Hygiene Instruction (OHI) | Experimental | Procedure: Dental Cleaning and Oral Hygiene Instruction (OHI) |
| Oral Hygiene Instruction (OHI) only | Active comparator | Behavioral: Oral Hygiene Instruction (OHI) |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- participants from the ongoing Mitigation of Cardiovascular Disease Risks in Children with Extreme Obesity (MODERN) study (NCT06967389)
- Class 2 or 3 obesity (BMI =120% of the 95th percentile for age and sex)
Key exclusion criteria (8 listed)
- Same exclusion as parent study.
- Planning to receive or complete dental services during the 12-month course of the study
- Ongoing orthodontic treatment
- Use of any anti-inflammatory medication (other than steroids) within 1 month prior to enrollment
- Currently taking medications that could influence the characteristics or response to periodontal treatment (e.g., use of immunosuppressants or steroids)
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 |
|---|---|---|
| Dental Cleaning and Oral Hygiene Instruction (OHI)Participants receive dental cleaning and oral hygiene instruction (OHI) and oral health assessments at baseline (prior to initiating weight-loss medication), 6 months (±2 weeks), and 12 months (±1 month) post-enrollment. | Procedure or surgery | Dental cleaning and Oral Hygiene Instruction (OHI) |
| Oral Hygiene Instruction (OHI)Participants will receive standard oral health care, including instructions on how to care for their teeth (OHI). Dental cleaning provided at 12 months. | Behavioural | Oral Hygiene Instruction (OHI) only |
Primary outcome
Change in gingival index
Time frame: Baseline, 6 months, 12 months
Based on visual assessment and gentle probing of the marginal periodontal tissues. Scored on a 0-3 scale and the higher score means increased inflammation.
Change in probing depth
Time frame: Baseline, 6 months, 12 months
Measuring the pocket depth at six sites per tooth (in millimeters) using a UNC-15 periodontal probe.
Change in BOP (Bleeding on probing)
Time frame: Baseline, 6 months, 12 months
Presence or absence of bleeding upon probing recorded at six sites per tooth.
Change in Plaque Index
Time frame: Baseline, 6 months, 12 months
Measured using a plaque score (0-3) at six specific Ramfjord teeth
Change in Clinical Attachment Level (CAL)
Time frame: Baseline, 6 months, 12 months
Calculated as PD (Pocket Depth) + GM (Gingival Margin) for each site.
Change in Gingival Margin Position (GM)
Time frame: Baseline, 6 months, 12 months
Recorded at six sites per tooth (in millimeters) using a UNC-15 periodontal probe.
Number of participants with Supragingival and Subgingival Calculus
Time frame: Baseline, 6 months, 12 months
Recorded as present or absent, generalized or localized when visible or detected upon probing.
Change in Gingival Crevicular Fluid (GCF)
Time frame: Baseline, 6 months, 12 months
Up to six samples per participant using Periopaper strips at mesiobuccal interproximal sites.
Change in Bacterial Subgingival Biofilm
Time frame: Baseline, 6 months, 12 months
Collected from the same sites as GCF using sterile endodontic paper points.
Change in levels of Interleukin-1 beta (IL-1β)
Time frame: Baseline, 6 months, 12 months
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Change in levels of Tumor Necrosis Factor-alpha
Time frame: Baseline, 6 months, 12 months
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Change in levels of Interleukin-6 (IL-6)
Time frame: Baseline, 6 months, 12 months
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Change in levels of C-reactive protein (CRP)
Time frame: Baseline, 6 months, 12 months
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Change in levels of Soluble intercellular adhesion molecule-1 (sICAM-1)
Time frame: Baseline, 6 months, 12 months
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Change in levels of Soluble vascular cell adhesion molecule-1 (sVCAM-1)
Time frame: Baseline, 6 months, 12 months
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Change in levels of endocan
Time frame: Baseline, 6 months, 12 months
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Change in levels of Vascular Endothelial Growth Factor A (VEGF-A)
Time frame: Baseline, 6 months, 12 months
levels in gingival crevicular fluid (GCF) and saliva will be measured using multiplex immunoassays or ELISA to assess changes across the study time frame
Change in Oral Microbiome
Time frame: Baseline, 6 months, 12 months
DNA sequencing. Saliva will be collected.
Change in active oral microbiome (RNA sequencing)
Time frame: Baseline, 6 months, 12 months
RNA sequencing. Saliva will be collected.
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 8 Oct 2026.
- Parent Study.Link provided by the sponsor.
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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.
Shaddox contact
Oelisoa Andriankaja, DDS, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental Cleaning and Oral Hygiene Instruction (OHI) and Oral Hygiene Instruction (OHI) in people with Obesity and Dental Care for Children, run by Oelisoa Andriankaja 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 2 inclusion and 8 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 8 Oct 2026. 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 Oelisoa Mireille Andriankaja, DDS, MS, PhD (8595620597, oelisoa.andriankaja@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gingival index (time frame: Baseline, 6 months, 12 months). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Oct 2026.