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NCT Number: NCT07610902

Periodontal Inflammation and Epigenetics 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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 contraceptive medication.
  • Need to have a minimum of 20 teeth.

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 contraception,
  • 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.

Treatment and study plan

Non-surgical periodontal therapy will be administered

Procedure

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.

Other names: Scaling and root planing

Primary outcomes

  1. Host-specific epigenetic signatures

    Time frame: Baseline/Day 1

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

  2. Inflammatory cytokine profiles

    Time frame: Baseline/Day 1

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

  3. Periodontal microbial composition

    Time frame: Baseline/Day 1

    Subgingival plague will be analyzed to study periodontal microbial composition

Secondary outcomes

  1. Host epigenetic modifiers pre- and post-therapy

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

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

  2. Inflammatory cytokine changes pre- and post-therapy

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

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

  3. Periodontal microbial changes pre- and post-therapy

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

    Subgingival plague will be analyzed to study periodontal microbial changes.

Study contacts

Contact information is provided by the study sponsor or research team.

Jeanne St.Germain, RDH, B.S.

CONTACT

[email protected]

504-941-8276

Vinayak M Joshi, PhD, MS

CONTACT

[email protected]

15049418280

Sponsors and collaborators

Lead sponsor

Louisiana State University Health Sciences Center in New Orleans

Other

Registry information

Official study title

Association Between Epigenetic Changes, Periodontal Microbiota, And Periodontal Inflammation in Obese Individuals

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 28, 2026
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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