Clinical trial

Periodontal Inflammation and Epigenetics in Obese Individuals

Opening soon · Not applicable · 1 countries · Registry ID NCT07610902

Opening soonNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years
SexAll
Healthy volunteersAccepted
ConditionObesity, Periodontitis

Full registry 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.

Treatments and study arms

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.

Primary outcomes

Host-specific epigenetic signaturesBaseline/Day 1

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

Inflammatory cytokine profilesBaseline/Day 1

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

Periodontal microbial compositionBaseline/Day 1

Subgingival plague will be analyzed to study periodontal microbial composition

Study locations

1 locations were listed when this page was built. The first 40 are shown.

LSU Health Science Centre, School of Dentistry🇺🇸 New Orleans, Louisiana, United States
Vinayak M Joshi, PhD, MSContact
Jeanne St.Germain, RDH, B.S.Contact