ClinicalTrials.gg
Not yet recruitingNCT07610902Updated May 28, 2026

Periodontal Inflammation and Epigenetics in Obese Individuals

An interventional study of Non-surgical periodontal therapy will be administered in Obesity and Periodontitis, sponsored by Louisiana State University Health Sciences Center in New Orleans. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-28.

Sponsored by Louisiana State University Health Sciences Center in New Orleans · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Obesity
  • Periodontitis

Keywords

  • Obesity
  • Periodontitis
  • Epigenitics
  • Periodontal inflammation
03

In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 40 is below the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Louisiana State University Health Sciences Center in New Orleans is the lead sponsor of 72 studies on the registry; 12 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged ≥18 years,
  • No history of periodontal therapy in the last 6 months,
  • No use of tobacco,
  • No history of pregnancy lactation or medication.
  • Need to have a minimum of 20 teeth.

Exclusion criteria

Exclusion Criteria:

  • 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 ,
  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Active comparator
    non-obese with periodontitis

    Non-surgical periodontal therapy will be administered

    Procedure: Non-surgical periodontal therapy will be administered

  • Active comparator
    obese with periodontitis

    Non-surgical periodontal therapy will be administered

    Procedure: Non-surgical periodontal therapy will be administered

Interventions

  • ProcedureNon-surgical periodontal therapy will be administered

    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.

    Also known as: Scaling and root planing

06

What researchers measure

Primary outcomes

  1. Host-specific epigenetic signatures

    Gingival crevicular fluid and saliva will be analyzed to study epigenetic signatures

    Time frame: Baseline/Day 1

  2. Inflammatory cytokine profiles

    Gingival crevicular fluid and saliva will be analyzed to study inflammatory cytokine profiles.

    Time frame: Baseline/Day 1

  3. Periodontal microbial composition

    Subgingival plague will be analyzed to study periodontal microbial composition

    Time frame: Baseline/Day 1

Secondary outcomes

  1. Host epigenetic modifiers pre- and post-therapy

    Gingival crevicular fluid and saliva will be analyzed to study epigenetic changes.

    Time frame: Baseline/Day 1, Day 30, Day 90

  2. Inflammatory cytokine changes pre- and post-therapy

    Gingival crevicular fluid and saliva will be analyzed to study inflammatory cytokine changes.

    Time frame: Baseline/Day 1, Day 30, Day 90

  3. Periodontal microbial changes pre- and post-therapy

    Subgingival plague will be analyzed to study periodontal microbial changes.

    Time frame: Baseline/Day 1, Day 30, Day 90

07

Study locations

1 site
  • LSU Health Science Centre, School of Dentistry
    New Orleans, Louisiana 70119, United States
08

References and documents

Individual participant data

Plan to share: No — Aggregated data will be published as a peer reviewed manuscript.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 28, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07610902
Lead sponsor
Louisiana State University Health Sciences Center in New Orleans
Responsible party
Sponsor
First posted
May 28, 2026
Start date
May 25, 2026 (estimated)
Primary completion
Dec 30, 2026 (estimated)
Completion
Dec 30, 2026 (estimated)
Last update
May 28, 2026

Study contacts

Vinayak M Joshi, PhD, MS
Contact
vjosh1@lsuhsc.edu
15049418280
Jeanne St.Germain, RDH, B.S.
Contact
jstge1@lsuhsc.edu
504-941-8276

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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