Periodontal Attachment LossNCT03073174
Dietary Intakes and Periodontal Health: A Follow-Up Study
An observational study of Periodontal Attachment Loss and Periodontal Pocket, run by Brock University at 1 site in Canada.
Trial summary
A previous study, on which this study is based, 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 (NCT02291835). 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
- 43 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2017to 1 May 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: Adult patients who previously underwent sanative therapy to manage periodontal disease and who have regular maintenance periodontal cleanings on a regular basis at the clinic.
Who may be able to join
- previously participated in the original study (NCT02291835)
Who cannot join
- under 19 years of age
- have not participated in the previous study as this study is a direct follow-up of those participants
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: Dietary Intakes and Periodontal Outcomes After Sanative Therapy: A Follow-Up Study
A previous study, on which this study is based, 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 (NCT02291835). The investigator's next step, in the present study, is to determine long-term benefits of sanative therapy in which patients have regular maintenance hygiene cleanings on periodontal health. Specifically, the relationship between intakes of specific foods, nutrients and supplements with clinical periodontal outcomes will be studied.
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 involving mechanical debridement of bacterial biofilms on roots of teeth, below the gum line. Participants in this present study previously underwent sanative therapy several years ago and have been attending the clinic for regular maintenance appointments to maintain periodontal health. While significant associations were observed with higher intakes of fruits and vegetables and specific nutrients (vitamins C and E, beta-carotene, fish oils) within a few months after sanative therapy, this study will follow-up these findings to determine if such relationships persist during a period of relatively stable periodontal health. Given new insights into a potential role of flavonoids in maintaining periodontal health, this aspect will also be studied. The overall objective is to determine if higher intakes of foods, nutrients and supplements known to have osteogenic and immunomodulatory effects are associated with improved clinical outcomes in individuals who previously underwent sanative therapy. At the regular maintenance appointment, clinical measures will be evaluated (clinical attachment loss, probing depth, bleeding on probing, plaque index). As well, the following will be evaluated: 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 specially developed questionnaires and salivary markers of inflammation using biochemical assays.
- Conditions
- Periodontal Attachment Loss, Periodontal Pocket
- Keywords
- dietary intake, nutritional supplements, sanative therapy, healing, flavonoids, tea
- Medical subject headings
- Periodontal Attachment Loss, Periodontal Pocket
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)
Clinical Attachment Loss is a routine clinical measure of periodontal health (measured in mm)
Measured: At maintenance appointment (1 hour)
Secondary outcomes (3)
Probing Depth
Probing depth is a routine clinical measure of periodontal health (measured in mm)
Measured: At maintenance appointment (1 hour)
Bleeding on Probing
Bleeding on Probing is a measure of inflammation and determined as the percent of bleeding sites that are measured at 6 sites per tooth.
Measured: At maintenance appointment (1 hour)
Plaque Index
O'Leary Plaque Score Index is a score of the total amount of plaque present at 4 surfaces of the tooth.
Measured: At maintenance appointment (1 hour)
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 completion1 Apr 2018
- Study completion1 May 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
- 43 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
- NCT03073174
- Sponsor's protocol ID
- 16-131
- Status last verified
- May 2018
- First submitted
- 3 Mar 2017
- Last updated
- 11 May 2018
- 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 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Intakes and Periodontal Outcomes After Sanative Therapy: A Follow-Up Study
- ClinicalTrials.gov ID
- NCT03073174
- Acronym / sponsor ID
- 16-131
- Conditions
- Periodontal Attachment Loss, Periodontal Pocket
- Keywords
- dietary intake, nutritional supplements, sanative therapy, healing, flavonoids, tea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 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
- 1 Apr 2018 (actual)
- Study completion
- 1 May 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.
A previous study, on which this study is based, 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 (NCT02291835). The investigator's next step, in the present study, is to determine long-term benefits of sanative therapy in which patients have regular maintenance hygiene cleanings on periodontal health. Specifically, the relationship between intakes of specific foods, nutrients and supplements with clinical periodontal outcomes will be studied.
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 involving mechanical debridement of bacterial biofilms on roots of teeth, below the gum line. Participants in this present study previously underwent sanative therapy several years ago and have been attending the clinic for regular maintenance appointments to maintain periodontal health. While significant associations were observed with higher intakes of fruits and vegetables and specific nutrients (vitamins C and E, beta-carotene, fish oils) within a few months after sanative therapy, this study will follow-up these findings to determine if such relationships persist during a period of relatively stable periodontal health. Given new insights into a potential role of flavonoids in maintaining periodontal health, this aspect will also be studied. The overall objective is to determine if higher intakes of foods, nutrients and supplements known to have osteogenic and immunomodulatory effects are associated with improved clinical outcomes in individuals who previously underwent sanative therapy. At the regular maintenance appointment, clinical measures will be evaluated (clinical attachment loss, probing depth, bleeding on probing, plaque index). As well, the following will be evaluated: 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 specially developed questionnaires and salivary markers of inflammation using biochemical assays.
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
- Adult patients who previously underwent sanative therapy to manage periodontal disease and who have regular maintenance periodontal cleanings on a regular basis at the clinic.
Key inclusion criteria (1 listed)
- previously participated in the original study (NCT02291835)
Key exclusion criteria (2 listed)
- under 19 years of age
- have not participated in the previous study as this study is a direct follow-up of those participants
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 maintenance appointment (1 hour)
Clinical Attachment Loss is a routine clinical measure of periodontal health (measured in mm)
3 secondary outcomes
Probing Depth
Time frame: At maintenance appointment (1 hour)
Bleeding on Probing
Time frame: At maintenance appointment (1 hour)
Plaque Index
Time frame: At maintenance appointment (1 hour)
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 11 May 2018.
- 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 2 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 11 May 2018. 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 maintenance appointment (1 hour)). 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 11 May 2018.