Periodontal Inflammation and Epigenetics in Obese Individuals
Association Between Epigenetic Changes, Periodontal Microbiota, And Periodontal Inflammation 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Vinayak M Joshi, PhD, MS
- Telefonnummer: 15049418280
- E-mail: vjosh1@lsuhsc.edu
Undersøgelse Kontakt Backup
- Navn: Jeanne St.Germain, RDH, B.S.
- Telefonnummer: 504-941-8276
- E-mail: jstge1@lsuhsc.edu
Studiesteder
-
-
Louisiana
-
New Orleans, Louisiana, Forenede Stater, 70119
- LSU Health Science Centre, School of Dentistry
-
Kontakt:
- Vinayak M Joshi, PhD, MS
- Telefonnummer: 15049418280
- E-mail: vjosh1@lsuhsc.edu
-
Kontakt:
- Jeanne St.Germain, RDH, B.S.
- Telefonnummer: 504-941-8276
- E-mail: jstge1@lsuhsc.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: non-obese with periodontitis
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 procedure.
The Deep cleaning procedure are carried out using hand instruments and ultrasonic instruments.
Andre navne:
|
|
Aktiv komparator: obese with periodontitis
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 procedure.
The Deep cleaning procedure are carried out using hand instruments and ultrasonic instruments.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Host-specific epigenetic signatures
Tidsramme: Baseline/Day 1
|
Gingival crevicular fluid and saliva will be analyzed to study epigenetic signatures
|
Baseline/Day 1
|
|
Inflammatory cytokine profiles
Tidsramme: Baseline/Day 1
|
Gingival crevicular fluid and saliva will be analyzed to study inflammatory cytokine profiles.
|
Baseline/Day 1
|
|
Periodontal microbial composition
Tidsramme: Baseline/Day 1
|
Subgingival plague will be analyzed to study periodontal microbial composition
|
Baseline/Day 1
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Host epigenetic modifiers pre- and post-therapy
Tidsramme: Baseline/Day 1, Day 30, Day 90
|
Gingival crevicular fluid and saliva will be analyzed to study epigenetic changes.
|
Baseline/Day 1, Day 30, Day 90
|
|
Inflammatory cytokine changes pre- and post-therapy
Tidsramme: Baseline/Day 1, Day 30, Day 90
|
Gingival crevicular fluid and saliva will be analyzed to study inflammatory cytokine changes.
|
Baseline/Day 1, Day 30, Day 90
|
|
Periodontal microbial changes pre- and post-therapy
Tidsramme: Baseline/Day 1, Day 30, Day 90
|
Subgingival plague will be analyzed to study periodontal microbial changes.
|
Baseline/Day 1, Day 30, Day 90
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Periodontale sygdomme
- Mundsygdomme
- Stomatognatiske sygdomme
- Ernæringsforstyrrelser
- Overernæring
- Kropsvægt
- Overvægtig
- Patologiske tilstande, tegn og symptomer
- Ernæringsmæssige og metaboliske sygdomme
- Tegn og symptomer
- Paradentose
- Fedme
- Fordøjelsessystem og orale fysiologiske fænomener
- Tandlæge
- Dental fysiologiske fænomener
- Dental skalering
- Dental profylakse
- Periodontics
- Subgingival curettage
- Forebyggende tandlæge
- Root Planning
- Tandfoliering
Andre undersøgelses-id-numre
- 8320 (New York State Psychiatric Institute Institutional Review Board)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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