ObesityNCT07610902
Periodontal Inflammation and Epigenetics in Obese Individuals
A study testing Non-surgical periodontal therapy will be administered in people with Obesity and Periodontitis, run by Louisiana State University Health Sciences Center in New Orleans at 1 site in United States.
Trial summary
The goal of this study is to investigate the long-term changes in host epigenetic modifications in obese individuals with periodontitis. The aims of the study are: To monitor longitudinal changes in host epigenetic modifiers following non-surgical periodontal therapy in periodontitis patients Study subjects would be… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Periodontitis
- What is being tested?
- Non-surgical periodontal therapy will be administered
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 May 2026to 30 Dec 2026
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 years,
- No history of periodontal therapy in the last 6 months,
- No use of tobacco,
- No history of pregnancy lactation or contraceptive medication.
- Need to have a minimum of 20 teeth.
Who cannot join
- Had antimicrobial/antiviral therapy in the previous 3 months,
- History of uncontrolled diabetes,
- History of rheumatoid arthritis,
- History of osteoporosis,
- History of oral cancer,
- Currently taking hormonal contraception,
Show all 10Show fewer
- If pregnant or lactating currently or prior 6 months,
- Subjects on current weight loss drugs
- If planning weight reduction surgery during the time of the study
- Any other condition, disease or therapy with documented influence on oral inflammation and/or oral microbial environment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
LSU Health Science Centre, School of Dentistry
New Orleans, Louisiana, 70119
Vinayak M Joshi, PhD, MS, 15049418280, vjosh1@lsuhsc.edu
Jeanne St.Germain, RDH, B.S., 504-941-8276, jstge1@lsuhsc.edu
About this study
Official title: Association Between Epigenetic Changes, Periodontal Microbiota, And Periodontal Inflammation in Obese Individuals
The goal of this study is to investigate the long-term changes in host epigenetic modifications in obese individuals with periodontitis. The aims of the study are:
- To monitor longitudinal changes in host epigenetic modifiers following non-surgical periodontal therapy in periodontitis patients Study subjects would be categorized into two groups, non-obese with periodontitis, and obese with periodontitis. The study will primarily evaluate changes among these groups cross-sectionally, then longitudinally following non-surgical periodontal therapy (deep cleaning) to determine if any changes occur with treatment.
Read the detailed description
Periodontitis is an inflammatory disease process primarily caused by microorganisms, which affects the tooth-supporting structures and can eventually lead to tooth loss. Oral health is a reflection of general health. Accordingly, obesity can influence periodontitis and increase its severity. The study participants will be categorized into two groups as described above. Enrolled participants will be balanced for distribution of age, gender, ethnicity, and general health.
The objective of this pilot study is to investigate the cross-sectional and longitudinal changes in host epigenetic modifications in obese individuals with periodontitis. The investigators intend to examine these host epigenetic changes in obese and non-obese individuals with both periodontal health and periodontitis. The study will primarily evaluate longitudinal changes following non-surgical periodontal therapy (considered the gold standard for the initial treatment of periodontitis) to determine whether any modifications occur with treatment.
To control for other factors affecting periodontitis, the investigators plan to exclude diabetic participants, document oral hygiene habits, and monitor periodontal microorganisms and inflammatory mediators in the groups for further associations. In summary, the study will identify important epigenetic signatures in obese participants with periodontal disease compared to those with periodontal health as a potential causal factor linking the two conditions.
The investigators hypothesize that epigenetic programs in obese individuals will influence the severity of periodontal disease by altering inflammatory pathways and the microbial environment.
- Conditions
- Obesity, Periodontitis
- Being tested
- Non-surgical periodontal therapy will be administered
- Keywords
- Obesity, Periodontitis, Epigenitics, Periodontal inflammation
- Medical subject headings
- Obesity, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-surgical periodontal therapy will be administeredProcedure or surgery
Also called Scaling and root planing
Non-surgical periodontal therapy (Deep cleaning-SRP): The deep cleaning by a scaling and root planing (SRP) procedure, is the standard initial treatment for all individuals diagnosed with periodontitis (periodontal disease). At the initial treatment planning appointment, each subject will receive intra-oral and extra-oral examination along with full mouth examination of the periodontal status, followed by diagnosis and treatment planning. The subject will then be scheduled for a deep cleaning procedure. The Deep cleaning procedure are carried out using hand instruments and ultrasonic instruments.
| Study group | Role | What they receive |
|---|---|---|
| non-obese with periodontitis | Active comparator | Non-surgical periodontal therapy will be administered Receives: Procedure: Non-surgical periodontal therapy will be administered |
| obese with periodontitis | Active comparator | Non-surgical periodontal therapy will be administered Receives: Procedure: Non-surgical periodontal therapy will be administered |
What is being measured
The primary outcome is the main question the study is designed to answer.
Host-specific epigenetic signatures
Gingival crevicular fluid and saliva will be analyzed to study epigenetic signatures
Measured: Baseline/Day 1
Inflammatory cytokine profiles
Gingival crevicular fluid and saliva will be analyzed to study inflammatory cytokine profiles.
Measured: Baseline/Day 1
Periodontal microbial composition
Subgingival plague will be analyzed to study periodontal microbial composition
Measured: Baseline/Day 1
Secondary outcomes (3)
Host epigenetic modifiers pre- and post-therapy
Gingival crevicular fluid and saliva will be analyzed to study epigenetic changes.
Measured: Baseline/Day 1, Day 30, Day 90
Inflammatory cytokine changes pre- and post-therapy
Gingival crevicular fluid and saliva will be analyzed to study inflammatory cytokine changes.
Measured: Baseline/Day 1, Day 30, Day 90
Periodontal microbial changes pre- and post-therapy
Subgingival plague will be analyzed to study periodontal microbial changes.
Measured: Baseline/Day 1, Day 30, Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start25 May 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups, non-obese with periodontitis, and obese with periodontitis. Study subjects enrolled will be balanced for distribution of age, gender, ethnicity and general health
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07610902
- Sponsor's protocol ID
- 8320
- Status last verified
- May 2026
- First submitted
- 19 Dec 2025
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Aggregated data will be published as a peer reviewed manuscript.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Epigenetic Changes, Periodontal Microbiota, And Periodontal Inflammation in Obese Individuals
- ClinicalTrials.gov ID
- NCT07610902
- Acronym / sponsor ID
- 8320
- Conditions
- Obesity, Periodontitis
- Keywords
- Obesity, Periodontitis, Epigenitics, Periodontal inflammation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Study start
- 25 May 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 28 May 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 study is to investigate the long-term changes in host epigenetic modifications in obese individuals with periodontitis. The aims of the study are:
- To monitor longitudinal changes in host epigenetic modifiers following non-surgical periodontal therapy in periodontitis patients Study subjects would be categorized into two groups, non-obese with periodontitis, and obese with periodontitis. The study will primarily evaluate changes among these groups cross-sectionally, then longitudinally following non-surgical periodontal therapy (deep cleaning) to determine if any changes occur with treatment.
Detailed description
Periodontitis is an inflammatory disease process primarily caused by microorganisms, which affects the tooth-supporting structures and can eventually lead to tooth loss. Oral health is a reflection of general health. Accordingly, obesity can influence periodontitis and increase its severity. The study participants will be categorized into two groups as described above. Enrolled participants will be balanced for distribution of age, gender, ethnicity, and general health.
The objective of this pilot study is to investigate the cross-sectional and longitudinal changes in host epigenetic modifications in obese individuals with periodontitis. The investigators intend to examine these host epigenetic changes in obese and non-obese individuals with both periodontal health and periodontitis. The study will primarily evaluate longitudinal changes following non-surgical periodontal therapy (considered the gold standard for the initial treatment of periodontitis) to determine whether any modifications occur with treatment.
To control for other factors affecting periodontitis, the investigators plan to exclude diabetic participants, document oral hygiene habits, and monitor periodontal microorganisms and inflammatory mediators in the groups for further associations. In summary, the study will identify important epigenetic signatures in obese participants with periodontal disease compared to those with periodontal health as a potential causal factor linking the two conditions.
The investigators hypothesize that epigenetic programs in obese individuals will influence the severity of periodontal disease by altering inflammatory pathways and the microbial environment.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups, non-obese with periodontitis, and obese with periodontitis. Study subjects enrolled will be balanced for distribution of age, gender, ethnicity and general health
| Arm | Type | Receives |
|---|---|---|
| non-obese with periodontitis | Active comparator | Procedure: Non-surgical periodontal therapy will be administeredNon-surgical periodontal therapy will be administered |
| obese with periodontitis | Active comparator | Procedure: Non-surgical periodontal therapy will be administeredNon-surgical periodontal therapy will be administered |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged ≥18 years,
- No history of periodontal therapy in the last 6 months,
- No use of tobacco,
- No history of pregnancy lactation or contraceptive medication.
- Need to have a minimum of 20 teeth.
Key exclusion criteria (10 listed)
- Had antimicrobial/antiviral therapy in the previous 3 months,
- History of uncontrolled diabetes,
- History of rheumatoid arthritis,
- History of osteoporosis,
- History of oral cancer,
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 |
|---|---|---|
| Non-surgical periodontal therapy will be administeredAlso: Scaling and root planingNon-surgical periodontal therapy (Deep cleaning-SRP): The deep cleaning by a scaling and root planing (SRP) procedure, is the standard initial treatment for all individuals diagnosed with periodontitis (periodontal disease). At the initial treatment planning appointment, each subject will receive intra-oral and extra-oral examination along with full mouth examination of the periodontal status, followed by diagnosis and treatment planning. The subject will then be scheduled for a deep cleaning procedure. The Deep cleaning procedure are carried out using hand instruments and ultrasonic instruments. | Procedure or surgery | non-obese with periodontitis, obese with periodontitis |
Primary outcome
Host-specific epigenetic signatures
Time frame: Baseline/Day 1
Gingival crevicular fluid and saliva will be analyzed to study epigenetic signatures
Inflammatory cytokine profiles
Time frame: Baseline/Day 1
Gingival crevicular fluid and saliva will be analyzed to study inflammatory cytokine profiles.
Periodontal microbial composition
Time frame: Baseline/Day 1
Subgingival plague will be analyzed to study periodontal microbial composition
3 secondary outcomes
Host epigenetic modifiers pre- and post-therapy
Time frame: Baseline/Day 1, Day 30, Day 90
Inflammatory cytokine changes pre- and post-therapy
Time frame: Baseline/Day 1, Day 30, Day 90
Periodontal microbial changes pre- and post-therapy
Time frame: Baseline/Day 1, Day 30, Day 90
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 28 May 2026.
- Individual participant dataSharing planned: No. Aggregated data will be published as a peer reviewed manuscript.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-surgical periodontal therapy will be administered in people with Obesity and Periodontitis, run by Louisiana State University Health Sciences Center in New Orleans 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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 28 May 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 Vinayak M Joshi, PhD, MS (15049418280, vjosh1@lsuhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Host-specific epigenetic signatures (time frame: Baseline/Day 1). 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?
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 28 May 2026.