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PeriodontitisPhase 2DAPNCT01976806

The Effects of DHA on Periodontitis

A Phase 2 study testing Aspirin and Docosahexaenoic acid in people with Periodontitis and Gingivitis, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to determine whether docosahexaenoic acid (DHA) is effective in the treatment of periodontitis in adults. Read more about this study

Who is it for?
Ages 40 years and olderHealthy volunteers can take part
Conditions the study is for
Periodontitis, Gingivitis, Inflammation
What is being tested?
Aspirin and Docosahexaenoic acid
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
55 participants
Where
1 siteUnited States
Study dates
Jun 2009to Sep 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • age >40 years
  • >20 natural teeth (excluding third molars)
  • no orthodontic appliances
  • periodontitis defined as >4 teeth with pocket probing depths >5 mm

Who cannot join

  • pregnancy
  • diabetes
  • severe chronic diseases
  • gastrointestinal bleeding
  • uncontrolled chronic diseases
  • autoimmune disorders
Show all 21Show fewer
  • conditions requiring antibiotic prophylaxis
  • warfarin
  • clopidogrel
  • antimicrobial therapy within 30 days
  • chronic use of non-steroidal anti-inflammatory drugs (other than aspirin)
  • omega-3 fatty acid use within 6 months
  • loose teeth
  • painful teeth
  • periodontal abscess
  • pocket depths >10 mm in >1 tooth
  • periodontal therapy within the past two years
  • allergy to aspirin
  • allergy to fish oil
  • allergy to corn oil
  • allergy to soybean oil

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

Official title: The Effects of Docosahexaenoic Acid on Periodontitis in Adults: A Pilot Randomized Controlled Trial

The purpose of this study is to determine whether docosahexaenoic acid (DHA) is effective in the treatment of periodontitis in adults.

Read the detailed description
  1. The primary aim of this study is to investigate the effect of docosahexaenoic acid (DHA; 2 gm/day) plus low dose aspirin (ASA 81 mg/day)compared to ASA alone on periodontitis over three months. Our hypothesis is that DHA plus ASA will improve periodontitis as measured by objective periodontal exam, including decreased pocket depth (mm), gingival index (0-3), plaque index (0-3) and bleeding on probing (yes/no) compared to ASA alone.
  2. Assess the effect of DHA and ASA exposure on markers of local inflammation, including gingival crevicular fluid (GCF) CRP, IL-1 beta and IL-6 three months after exposure to DHA plus ASA compared to ASA alone.
  3. Evaluate potential mechanisms through changes in the periodontal microbial flora which may occur as a result of exposure to DHA and ASA compared to ASA alone. Our hypothesis is that there will be a substantial post therapy change in the microbial flora of dental plaques, favoring bacteria associated with a lower systemic inflammatory state.
  4. Assess the effect of DHA and ASA exposure on markers of systemic inflammation, including serum C-Reactive Protein (CRP), interleukin-6 (IL-6) and vascular adhesion molecule (VCAM) compared to ASA. Our hypothesis is that there will be a decrease in serum CRP, IL-6 and VCAM three months after exposure to DHA plus ASA compared to ASA alone.
  5. Assess the effect of DHA and ASA exposure on markers of systemic bone turnover, including urine N-terminal telopeptide (NTx) compared to ASA. Our hypothesis is that there will be a decrease in urine NTx three months after exposure to DHA plus ASA compared to ASA alone.
Being tested
Aspirin, Docosahexaenoic acid, Placebo (for Docosahexaenoic acid)
Keywords
Docosahexaenoic acid, DHA, Periodontitis, Gingivitis, Omega-3 fatty acid, Fish oil
Medical subject headings
Periodontitis, Gingivitis, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AspirinDrug

    Also called Baby Aspirin, Low Dose Aspirin

  • Docosahexaenoic acidDrug

    Also called DHA

  • Placebo (for Docosahexaenoic acid)Drug

    Also called 50% corn oil/50% soybean oil

    Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules

Study groups in NCT01976806
Study groupRoleWhat they receive
Aspirin & Docosahexaenoic acidExperimentalAspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months
Receives: Drug: Aspirin; Drug: Docosahexaenoic acid
Aspirin & PlaceboActive comparatorAspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months
Receives: Drug: Aspirin; Drug: Placebo (for Docosahexaenoic acid)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Pocket Depth (mm)

    Pocket probing depth (PD) is the depth a dental probe can be inserted into a gingival pocket at a particular site (6 sites per tooth) measured in millimeters among teeth with PD greater than or equal to 5 mm (N=533 dental sites total).

    Measured: Baseline and 3 months

Secondary outcomes (10)

  1. Change in Gingival Index (0-3)

    Gingival Index (GI) is a measure of gingival inflammation, which is assigned a score (0-3).

    Score Criteria:

    0: No inflammation.

    1. Mild inflammation, slight change in color, slight edema, no bleeding on probing.
    2. Moderate inflammation, moderate glazing, redness, bleeding on probing.
    3. Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding.

    Measured: Baseline and 3 months

  2. Change in Plaque Index (0-3)

    Plaque Index (PI) is a measure of gingival inflammation as induced by bacterial plaque deposition at and under the gum line.

    Score Criteria:

    0: No plaque

    1. A film of plaque adhering to the free gingival margin and adjacent area of the tooth, which can not be seen with the naked eye. But only by using disclosing solution or by using probe.
    2. Moderate accumulation of deposits within the gingival pocket, on the gingival margin and/ or adjacent tooth surface, which can be seen with the naked eye.
    3. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.

    Measured: Baseline and 3 months

  3. Sites With Bleeding on Probing (Yes/no)

    Bleeding On Probing (BOP) is a measure of gingival inflammation and tissue destruction, which describes whether or not bleeding at the dental pocket occurred following probing.

    Measured: 3 months

  4. Gingival Crevicular Fluid High Sensitivity C-reactive Protein

    Gingival crevicular fluid (GCF) is the fluid bathing the teeth under the gum line. GCF samples were analyzed for high sensitivity C-reactive protein as a measure of local gingival inflammation.

    Measured: Baseline and 3 months

  5. Gingival Crevicular Fluid Interleukin-6

    Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-6, which is a measure of local gingival inflammation.

    Measured: Baseline and 3 months

  6. Gingival Crevicular Fluid Interleukin-1 Beta

    Gingival crevicular fluid (GCF) samples were analyzed for Interleukin-1 beta, which is a measure of local gingival inflammation.

    Measured: Baseline and 3 months

  7. Serum High-sensitivity C-reactive Protein

    Serum high-sensitivity C-reactive protein is a measure of systemic inflammation.

    Measured: Baseline and 3 months

  8. Serum High-sensitivity Interleukin-6

    Serum high-sensitivity interleukin-6 is a measure of systemic inflammation.

    Measured: Baseline and 3 months

  9. Serum Soluble Vascular Cell Adhesion Molecule

    Serum soluble vascular cell adhesion molecule (VCAM) is a measure of systemic inflammation.

    Measured: Baseline and 3 months

  10. Urine N-Terminal Telopeptides

    Urine N-Terminal Telopeptides are a measure of systemic bone turnover.

    Measured: Baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2013 (estimated)
  2. Study startJun 2009
  3. Primary completionSep 2011
  4. Study completionSep 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01976806
Sponsor's protocol ID
GM-023
Other IDs
UL1RR025758-02
Acronym
DAP
Status last verified
Nov 2017
First submitted
30 Oct 2013
Last updated
13 Dec 2017
Data monitoring committee
No

Publications

  • Naqvi AZ, Mu L, Hasturk H, Van Dyke TE, Mukamal KJ, Goodson JM. Impact of Docosahexaenoic Acid Therapy on Subgingival Plaque Microbiota. J Periodontol. 2017 Sep;88(9):887-895. doi: 10.1902/jop.2017.160398. Epub 2017 May 18.

    PubMed 28517974

  • Naqvi AZ, Hasturk H, Mu L, Phillips RS, Davis RB, Halem S, Campos H, Goodson JM, Van Dyke TE, Mukamal KJ. Docosahexaenoic Acid and Periodontitis in Adults: A Randomized Controlled Trial. J Dent Res. 2014 Aug;93(8):767-73. doi: 10.1177/0022034514541125. Epub 2014 Jun 26.

    PubMed 24970858

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aspirin and Docosahexaenoic acid in people with Periodontitis and Gingivitis, run by Beth Israel Deaconess Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pocket Depth (mm) (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01976806, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2017.

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