Periodontal Inflammation and Epigenetics in Obese Individuals

Official title

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

Overview

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.

Interventions

• Procedure Non-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 pr

Primary outcome measures

• Host-specific epigenetic signatures [Time frame: Baseline/Day 1]
• Inflammatory cytokine profiles [Time frame: Baseline/Day 1]
• Periodontal microbial composition [Time frame: Baseline/Day 1]

Secondary outcome measures (3)

• 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Basic science

Study locations

United States · 1 center

• LSU Health Science Centre, School of Dentistry — New Orleans

Identifiers

NCT: NCT07610902 · 8320

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗