Periodontal Inflammation and Epigenetics in Obese Individuals

NCT07610902 | Not Yet Recruiting DMC

• 1 other identifier: 8320
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity; Periodontitis

Keywords

Obesity; Periodontitis; Epigenitics; Periodontal inflammation

Outcome Measures

Primary Outcomes (3)

• Host-specific epigenetic signatures

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

  Baseline/Day 1

• Inflammatory cytokine profiles

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

  Baseline/Day 1

• Periodontal microbial composition

  Subgingival plague will be analyzed to study periodontal microbial composition

  Baseline/Day 1

Secondary Outcomes (3)

• Host epigenetic modifiers pre- and post-therapy

  Baseline/Day 1, Day 30, Day 90

• Inflammatory cytokine changes pre- and post-therapy

  Baseline/Day 1, Day 30, Day 90

• Periodontal microbial changes pre- and post-therapy

  Baseline/Day 1, Day 30, Day 90

Study Arms (2)

non-obese with periodontitis

ACTIVE COMPARATOR

Non-surgical periodontal therapy will be administered

Procedure: Non-surgical periodontal therapy will be administered

obese with periodontitis

ACTIVE COMPARATOR

Non-surgical periodontal therapy will be administered

Procedure: Non-surgical periodontal therapy will be administered

Interventions

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.

Also known as: Scaling and root planing

non-obese with periodontitis; obese with periodontitis

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead

Study Sites (1)

LSU Health Science Centre, School of Dentistry

New Orleans, Louisiana, 70119, United States

Location

MeSH Terms

Conditions

Obesity; Periodontitis

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Central Study Contacts

Vinayak M Joshi, PhD, MS

CONTACT

15049418280; vjosh1@lsuhsc.edu

Jeanne St.Germain, RDH, B.S.

CONTACT

504-941-8276; jstge1@lsuhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: May 28, 2026
• Study Start: May 25, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: May 28, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)