LSU Health Science Centre, School of Dentistry
New Orleans, Louisiana, 70119, United States
Location contact
Jeanne St.Germain, RDH, B.S.
CONTACT
Vinayak M Joshi, PhD, MS
CONTACT
NCT Number: NCT07610902
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
New Orleans, Louisiana, 70119, United States
Jeanne St.Germain, RDH, B.S.
CONTACT
Vinayak M Joshi, PhD, MS
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Baseline/Day 1
Gingival crevicular fluid and saliva will be analyzed to study epigenetic signatures
Time frame: Baseline/Day 1
Gingival crevicular fluid and saliva will be analyzed to study inflammatory cytokine profiles.
Time frame: Baseline/Day 1
Subgingival plague will be analyzed to study periodontal microbial composition
Time frame: Baseline/Day 1, Day 30, Day 90
Gingival crevicular fluid and saliva will be analyzed to study epigenetic changes.
Time frame: Baseline/Day 1, Day 30, Day 90
Gingival crevicular fluid and saliva will be analyzed to study inflammatory cytokine changes.
Time frame: Baseline/Day 1, Day 30, Day 90
Subgingival plague will be analyzed to study periodontal microbial changes.
Contact information is provided by the study sponsor or research team.
Jeanne St.Germain, RDH, B.S.
CONTACT
Vinayak M Joshi, PhD, MS
CONTACT
Louisiana State University Health Sciences Center in New Orleans
Other
Association Between Epigenetic Changes, Periodontal Microbiota, And Periodontal Inflammation in Obese Individuals
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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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