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Periodontal Inflammation and Epigenetics in Obese Individuals

ConditionsObesityPeriodontitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorLouisiana State University Health Sciences Center in New Orleans

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Had antimicrobial/antiviral therapy in the previous 3 months,

History of uncontrolled diabetes,

History of rheumatoid arthritis,

History of osteoporosis,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Non-surgical periodontal therapy will be administered

    Procedure/Surgery

    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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: non-obese with periodontitisActive comparator 1 intervention
Group B: obese with periodontitisActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Host-specific epigenetic signatures

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

Time frame
Baseline/Day 1
2

Inflammatory cytokine profiles

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

Time frame
Baseline/Day 1
3

Periodontal microbial composition

Subgingival plague will be analyzed to study periodontal microbial composition

Time frame
Baseline/Day 1

Secondary outcomes

1

Host epigenetic modifiers pre- and post-therapy

Gingival crevicular fluid and saliva will be analyzed to study epigenetic changes.

Time frame
Baseline/Day 1, Day 30, Day 90
2

Inflammatory cytokine changes pre- and post-therapy

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

Time frame
Baseline/Day 1, Day 30, Day 90
3

Periodontal microbial changes pre- and post-therapy

Subgingival plague will be analyzed to study periodontal microbial changes.

Time frame
Baseline/Day 1, Day 30, Day 90

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Louisiana State University Health Sciences Center in New Orleans

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: