Periodontal Attachment LossNCT03073161
Flavonoid Intake and Periodontal Healing
An observational study of Periodontal Attachment Loss and Periodontal Pocket, run by Brock University at 1 site in Canada.
Trial summary
Periodontitis is a chronic inflammatory disease that, if untreated, will lead to tooth loss. To treat periodontal disease, sanative therapy is used as a first line cost-effective strategy to manage periodontal disease and thus prevent tooth loss. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Periodontal Attachment Loss, Periodontal Pocket
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2017to 31 Aug 2018
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing sanative therapy for the treatment of moderate to severe chronic generalized periodontitis.
Who may be able to join
- Adult patients undergoing sanative therapy for moderate to severe chronic generalized periodontitis. Chronic periodontitis is classified as generalized if >30% of sites are involved. Severity of periodontitis is based on the amount of clinical attachment loss (CAL) with moderate and severe chronic generalized periodontitis defined as 3 to 4 mm CAL or > 5 mm CAL, respectively.
Who cannot join
- under 19 years of age
Trial locations and contacts
1 site in 1 country.
Canada1 site
Dr. Peter C. Fritz, Reconstructive Periodontics and Implant Surgery
Fonthill, Ontario, L0S1E5
About this study
Official title: Flavonoid Intake and Periodontal Outcomes After Sanative Therapy
Periodontitis is a chronic inflammatory disease that, if untreated, will lead to tooth loss. To treat periodontal disease, sanative therapy is used as a first line cost-effective strategy to manage periodontal disease and thus prevent tooth loss. Diet is emerging as a modifiable factor that may help an individual to more fully respond to treatments such as sanative therapy. Dietary flavonoids, abundant in fruits and tea, may be particularly beneficial. Patients with moderate to severe chronic generalized periodontitis and undergoing sanative therapy will be recruited for the study. Mean clinical attachment loss as well as other clinical measures will be assessed at baseline and 8 to 12 weeks following sanative therapy to measure periodontal healing. At baseline and follow-up appointment, the following will be assessed to examine associations with clinical measures of periodontal healing: intakes of macronutrients and micronutrients, fruits, vegetables and tea as well as supplement use and salivary markers of inflammation.
Read the detailed description
Periodontitis is a chronic oral infection that results in the breakdown of connective tissue and alveolar bone that support the teeth. Bacteria and the body's own immune system mediate the severity of periodontitis, where teeth may become loose, fall out or have to be removed. Sanative therapy is a non-surgical process invovling mechanical debridement of bacterial biofilms on roots of teeth, below the gum line. A previous study found that a diet higher in fruits and vegetables, beta-carotene, vitamin C, alpha-tocopherol, and fish oils (specifically eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) was positively associated with periodontal healing after sanative therapy. There is some evidence that higher intakes of flavonoids and thus flavonoid-containing foods may benefit periodontal health. These foods include a wide variety of fruits and tea. The relationship of flavonoid intake within the overall dietary pattern has not been assessed in relation to recovery from sanative therapy and associated markers of improved periodontal health. The overall objective is to determine if higher dietary flavonoid intakes are associated with improved clinical outcomes after sanative therapy compared to individuals with lower intakes. At baseline and the follow-up appointment, the following will be assessed: dietary intakes of macronutrients and micronutrients using the Block 2015 food frequency questionnaire; intakes of fruit, vegetables and fiber using the Block Dietary Fruit-Vegetable-Fiber Screener; nutritional supplement use and tea intake using in specially developed questionnaires and salivary markers of inflammation.
- Conditions
- Periodontal Attachment Loss, Periodontal Pocket
- Keywords
- flavonoids, tea, dietary intake, nutritional supplements, periodontal disease, healing, sanative therapy
- Medical subject headings
- Periodontal Attachment Loss, Periodontal Pocket, Periodontal Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Attachment Loss (CAL) (also called Periodontal Attachment Loss)
Periodontal healing is evaluated based on changes in clinical attachment loss (mm)
Measured: At baseline and at follow-up (8 to 12 weeks after completion of sanative therapy)
Secondary outcomes (3)
Probing Depth
Periodontal healing is evaluated based on changes in probing depth (mm)
Measured: At baseline and at follow-up (8 to 12 weeks after completion of sanative therapy)
Bleeding on Probing
Inflammation is determined by percent of bleeding sites that are measured at 6 sites per tooth
Measured: At baseline and at follow-up (8 to 12 weeks after completion of sanative therapy)
Plaque Index
O'Leary Plaque Score Index is a score of the total amount of plaque present at 4 surfaces of a tooth
Measured: At baseline and at follow-up (8 to 12 weeks after completion of sanative therapy)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start1 Jan 2017
- Primary completion30 Jun 2018
- Study completion31 Aug 2018
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brock University
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
- Responsible party
- Principal investigator, Wendy E. Ward, Ph.D., Brock University
- Investigators
- Wendy E Ward, Ph.D., Principal investigator, Brock University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03073161
- Sponsor's protocol ID
- 16-114
- Status last verified
- Jan 2019
- First submitted
- 3 Mar 2017
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flavonoid Intake and Periodontal Outcomes After Sanative Therapy
- ClinicalTrials.gov ID
- NCT03073161
- Acronym / sponsor ID
- 16-114
- Conditions
- Periodontal Attachment Loss, Periodontal Pocket
- Keywords
- flavonoids, tea, dietary intake, nutritional supplements, periodontal disease, healing, sanative therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Brock UniversityUniversity, hospital or other
- Collaborators
- Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 8 Mar 2017 (actual)
- 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.
Periodontitis is a chronic inflammatory disease that, if untreated, will lead to tooth loss. To treat periodontal disease, sanative therapy is used as a first line cost-effective strategy to manage periodontal disease and thus prevent tooth loss. Diet is emerging as a modifiable factor that may help an individual to more fully respond to treatments such as sanative therapy. Dietary flavonoids, abundant in fruits and tea, may be particularly beneficial. Patients with moderate to severe chronic generalized periodontitis and undergoing sanative therapy will be recruited for the study. Mean clinical attachment loss as well as other clinical measures will be assessed at baseline and 8 to 12 weeks following sanative therapy to measure periodontal healing. At baseline and follow-up appointment, the following will be assessed to examine associations with clinical measures of periodontal healing: intakes of macronutrients and micronutrients, fruits, vegetables and tea as well as supplement use and salivary markers of inflammation.
Detailed description
Periodontitis is a chronic oral infection that results in the breakdown of connective tissue and alveolar bone that support the teeth. Bacteria and the body's own immune system mediate the severity of periodontitis, where teeth may become loose, fall out or have to be removed. Sanative therapy is a non-surgical process invovling mechanical debridement of bacterial biofilms on roots of teeth, below the gum line. A previous study found that a diet higher in fruits and vegetables, beta-carotene, vitamin C, alpha-tocopherol, and fish oils (specifically eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) was positively associated with periodontal healing after sanative therapy. There is some evidence that higher intakes of flavonoids and thus flavonoid-containing foods may benefit periodontal health. These foods include a wide variety of fruits and tea. The relationship of flavonoid intake within the overall dietary pattern has not been assessed in relation to recovery from sanative therapy and associated markers of improved periodontal health. The overall objective is to determine if higher dietary flavonoid intakes are associated with improved clinical outcomes after sanative therapy compared to individuals with lower intakes. At baseline and the follow-up appointment, the following will be assessed: dietary intakes of macronutrients and micronutrients using the Block 2015 food frequency questionnaire; intakes of fruit, vegetables and fiber using the Block Dietary Fruit-Vegetable-Fiber Screener; nutritional supplement use and tea intake using in specially developed questionnaires and salivary markers of inflammation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing sanative therapy for the treatment of moderate to severe chronic generalized periodontitis.
Key inclusion criteria (1 listed)
- Adult patients undergoing sanative therapy for moderate to severe chronic generalized periodontitis. Chronic periodontitis is classified as generalized if >30% of sites are involved. Severity of periodontitis is based on the amount of clinical attachment loss (CAL) with moderate and severe chronic generalized periodontitis defined as 3 to 4 mm CAL or > 5 mm CAL, respectively.
Key exclusion criteria (1 listed)
- under 19 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical Attachment Loss (CAL) (also called Periodontal Attachment Loss)
Time frame: At baseline and at follow-up (8 to 12 weeks after completion of sanative therapy)
Periodontal healing is evaluated based on changes in clinical attachment loss (mm)
3 secondary outcomes
Probing Depth
Time frame: At baseline and at follow-up (8 to 12 weeks after completion of sanative therapy)
Bleeding on Probing
Time frame: At baseline and at follow-up (8 to 12 weeks after completion of sanative therapy)
Plaque Index
Time frame: At baseline and at follow-up (8 to 12 weeks after completion of sanative therapy)
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 15 Jan 2019.
- Individual participant dataSharing planned: No
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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.
Wendy E Ward, Ph.D. principal investigator
Brock University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Attachment Loss and Periodontal Pocket, run by Brock University at 1 site in Canada.
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 1 inclusion and 1 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 15 Jan 2019. 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 Canada. 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.
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 (CAL) (also called Periodontal Attachment Loss) (time frame: At baseline and at follow-up (8 to 12 weeks after completion of sanative therapy)). 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 15 Jan 2019.