Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses

University of Kentucky

Status: Completed

Conditions: Periodontal Attachment Loss

Treatments: Dietary Supplement: Omega-3 Fatty acid (with SRP or OHI); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00632957

UK IRB # 04-0339-F1V

P20RR020145-04 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to test the hypothesis that dietary n-3 PUFA will have a beneficial effect on systemic and local markers of inflammation when combined with traditional, non-surgical periodontal therapy.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. ≥ 18 years of age, male or female
2. At least 20 natural teeth present at the time of periodontal examination
3. Be diagnosed with severe, chronic periodontitis;
4. Be willing to participate in the study

Exclusion criteria

1. <18 years of age
2. Less than 20 natural teeth present at time of periodontal examination
3. Unable or unwilling to provide informed consent or follow study protocol
4. Systemic conditions including diabetes mellitus and any cardiovascular condition that would require premedication prior to dental treatment
5. Use of systemic antibiotics within the last 3 months
6. Pregnancy as diagnosed by administered pregnancy test.
7. You are nursing a baby.
8. Are allergic to fish or fish products.
9. You are taking any other medications, such as dietary supplements, that could affect the outcome of the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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126 participants in 2 patient groups, including a placebo group

Fish oil

Active Comparator group

Treatment:

Dietary Supplement: Omega-3 Fatty acid (with SRP or OHI)

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo