Periodontal Attachment LossNCT00632957
Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses
A study testing Omega-3 Fatty acid (with SRP or OHI) in people with Periodontal Attachment Loss, run by University of Kentucky at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontal Attachment Loss
- What is being tested?
- Omega-3 Fatty acid (with SRP or OHI)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age, male or female
- At least 20 natural teeth present at the time of periodontal examination
- Be diagnosed with severe, chronic periodontitis;
- Be willing to participate in the study
Who cannot join
- <18 years of age
- Less than 20 natural teeth present at time of periodontal examination
- Unable or unwilling to provide informed consent or follow study protocol
- Systemic conditions including diabetes mellitus and any cardiovascular condition that would require premedication prior to dental treatment
- Use of systemic antibiotics within the last 3 months
- Pregnancy as diagnosed by administered pregnancy test.
Show all 9Show fewer
- You are nursing a baby.
- Are allergic to fish or fish products.
- You are taking any other medications, such as dietary supplements, that could affect the outcome of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky College of Dentistry
Lexington, Kentucky, 40536
About this study
Official title: Center for the Biologic Basis of Oral/Systemic Diseases Project 5: Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses.
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.
- Conditions
- Periodontal Attachment Loss
- Being tested
- Omega-3 Fatty acid (with SRP or OHI), Placebo
- Medical subject headings
- Periodontal Attachment Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 Fatty acid (with SRP or OHI)Dietary supplement
1000mg capsules three times daily, duration 28 weeks.
PlaceboDietary supplement
corn/soybean oil capsules 1g/three times daily
| Study group | Role | What they receive |
|---|---|---|
| Fish oil | Active comparator | Not described Receives: Dietary Supplement: Omega-3 Fatty acid (with SRP or OHI) |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical attachment loss
Measured: baseline, 8, 16, 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2008 (estimated)
- Study startSep 2004
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal Attachment LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kentucky
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Research Resources (NCRR)
- Investigators
- Dolph R. Dawson, DMD,MS, Principal investigator, University of Kentucky College of DentistryJeff L. Ebersole, Ph.D, Study chair, University of Kentucky College of DentistryM J Novak, Ph.D, Study director, University of Kentucky College of DentistryGilbert A. Boissonneault, Ph.D, Study director, University of Kentucky Division of Clinical Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00632957
- Sponsor's protocol ID
- UK IRB # 04-0339-F1V
- Other IDs
- P20RR020145-04
- Status last verified
- Apr 2011
- First submitted
- 29 Feb 2008
- Last updated
- 12 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Center for the Biologic Basis of Oral/Systemic Diseases Project 5: Oral Infections: Dietary Regulation of Local and Systemic Inflammatory Responses.
- ClinicalTrials.gov ID
- NCT00632957
- Acronym / sponsor ID
- UK IRB # 04-0339-F1V
- Conditions
- Periodontal Attachment Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of KentuckyUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Research Resources (NCRR)
- Study start
- Sep 2004
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 11 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish oil | Active comparator | Dietary Supplement: Omega-3 Fatty acid (with SRP or OHI) |
| Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 18 years of age, male or female
- At least 20 natural teeth present at the time of periodontal examination
- Be diagnosed with severe, chronic periodontitis;
- Be willing to participate in the study
Key exclusion criteria (9 listed)
- <18 years of age
- Less than 20 natural teeth present at time of periodontal examination
- Unable or unwilling to provide informed consent or follow study protocol
- Systemic conditions including diabetes mellitus and any cardiovascular condition that would require premedication prior to dental treatment
- Use of systemic antibiotics within the last 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 Fatty acid (with SRP or OHI)1000mg capsules three times daily, duration 28 weeks. | Dietary supplement | Fish oil |
| Placebocorn/soybean oil capsules 1g/three times daily | Dietary supplement | Placebo |
Primary outcome
clinical attachment loss
Time frame: baseline, 8, 16, 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dolph R. Dawson, DMD,MS principal investigator
University of Kentucky College of Dentistry
Jeff L. Ebersole, Ph.D study chair
University of Kentucky College of Dentistry
M J Novak, Ph.D study director
University of Kentucky College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omega-3 Fatty acid (with SRP or OHI) in people with Periodontal Attachment Loss, run by University of Kentucky 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 9 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 12 Apr 2011. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
clinical attachment loss (time frame: baseline, 8, 16, 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Apr 2011.