Periodontal PocketNCT03649789
Periodontal Outcomes After Sanative Therapy
An observational study of Periodontal Pocket and Xerostomia, run by Brock University at 2 sites in Canada.
Trial summary
Salivary gland hypofunction, or dry mouth, is a damaging oral condition that affects salivary gland production. Absence of saliva causes bad breath, dental decay, increased plaque accumulation, dry lips, mouth sores, and the inability to retain dentures or removable protheses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontal Pocket, Xerostomia, Dry Mouth
- How many people
- 120 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Aug 2018to 1 May 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients who previously underwent sanative therapy to manage periodontal disease at this clinic and who have regular maintenance periodontal cleanings on a regular basis at the clinic.
Who may be able to join
- have had sanative therapy at this clinic in the previous 1 to 5 years.
Who cannot join
- anyone who is unable to provide informed consent
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
Fonthill, Ontario, L0S1E5
Brock University
St. Catharines, Ontario, L2S3A1
About this study
Official title: Retrospective Study of Periodontal Outcomes After Sanative Therapy in Patients With or Without Salivary Gland Hypofunction
Salivary gland hypofunction, or dry mouth, is a damaging oral condition that affects salivary gland production. Absence of saliva causes bad breath, dental decay, increased plaque accumulation, dry lips, mouth sores, and the inability to retain dentures or removable protheses. This study will determine if patients with dry mouth have different periodontal health than patients without dry mouth. Additionally, this study will examine if patients who have their periodontal maintenance appointments solely at a periodontal speciality clinic have different periodontal health than patients who alternate their appointments between a specialty office and their general dental office.
Read the detailed description
Salivary gland hypofunction, or dry mouth, is a damaging oral condition that affects the function and flow rate of saliva. Low saliva rates can range from mild self-reported symptoms and discomfort to significant oral diseases. Saliva is essential in preventing irritation and friction of mucosal surfaces. Progressively dry mouth can cause oral and bodily conditions that can affect an individuals quality of life and daily tasks, such as eating and avoiding social situations. Specifically, dry mouth is a risk factor for periodontal disease, a chronic oral inflammation of tissues and ligaments that support the tooth's structure and if untreated, will ultimately lead to tooth loss. In Canada, the first line of defense against periodontal disease is non-surgical sanative therapy (ST). Participants in this study have been attending a periodontal specialty clinic for routine periodontal maintenance appointments for at least 1 to 5 years following their initial scaling and root planing. Salivary flow rate will be measured to determine the level of dry mouth. At the regular maintenance appointment, clinical measures will be evaluated (probing depth, bleeding on probing, plaque index, gingival index, thickness of tissues, mobility, and furcations). Patients will also complete a dry mouth questionnaire to determine if dry mouth influences the day to day life of a patient, and the patient's Registered Dental Hygienist will complete a short questionnaire outlining oral symptoms of dry mouth. Additionally, the investigators aim to see if a patient who has periodontal maintenance appointments at a specialty office has different clinical outcomes than a patient who alternates these appointments between a specialty office and a general dental office. Overall, the investigators will determine if thorough periodontal maintenance appointments are efficient in preventing periodontal disease in patients with dry mouth.
- Conditions
- Periodontal Pocket, Xerostomia, Dry Mouth, Periodontal Diseases
- Keywords
- healing, biomarkers, sanative therapy, nutritional supplements, medications, salivary flow
- Medical subject headings
- Periodontal Pocket, Xerostomia, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| No Salivary Gland Hypofunction | These individuals have an unstimulated salivary flow rate of greater than 0.1 mL saliva/min. | |
| Salivary Gland Hypofunction | These individuals have an unstimulated salivary flow rate of less than 0.1 mL saliva/min. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing Depth
Probing depth is a routine clinical measure of periodontal health (measured in mm)
Measured: At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
Secondary outcomes (9)
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) and retrospectively from the clinical record from time of sanative therapy onwards
O'Leary Index of Plaque Control
The patient's plaque index = the number of plaque-containing surfaces divided by the total number of available surfaces.
For instance, if a patient has 28 teeth they have 112 tooth surfaces (28x4=112) and if 40 surfaces contain plaque their plaque index is 40/112=0.357 or 35.7%.
The minimum plaque index would be 0%, which represents no tooth surfaces that contain plaque.
The maximum plaque index would be 100%, which represents all surfaces of the patient's teeth contain plaque.
The optimal outcome is to have a plaque index of 0%. The worst outcome would be a plaque index of 100%.
Measured: At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
Gingival Index (used to assess gingival condition to distinguish between the quality of gingiva and the location of gingival concerns).
The gingival index system consists of 4 possible ratings: 0 = Normal gingiva, 1 = mild inflammation with a slight change in colour, slight edema (no bleeding on probing); 2 = moderate inflammation with redness, edmea and glazing (bleeding on probing); or 3 = severe inflammation with marked redness and edema, ulceration, tendency to spontaneous bleeding.
Each four gingival areas of a tooth is given a score from 0 to 3. This corresponds to the gingival index for that area.
The scores from the four areas of the tooth can be added and divided by four to give the gingival index for the tooth.
The better outcome is having a gingival index of 0, the worst outcome is having a gingival outcome of 3.
Measured: At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
Thickness of Periodontal Tissue
Assessment of gingival tissue thickness to assess tissue quality and response to inflammation
Measured: At maintenance appointment (1 hour)
Body Mass Index (BMI)
Assessment of body weight and height to calculate BMI as it is a known risk factor for periodontal disease
Measured: At maintenance appointment (1 hour)
Dry Mouth Inventory Questionnaire Completed by the Patient (to assess impact of dry mouth on quality of life)
This questionnaire measures, at one time point, the self-reported daily limitations due to dry mouth. This inventory questionnaire includes 11 criteria and the questionnaire is completed by the patient.
The 11 criteria include: I sip liquids to aid in swallowing food; My mouth feels dry when eating a meal; I get up at night to drink; My mouth feels dry; I have difficulty in eating dry foods; I suck sweets or cough lollies to relieve dry mouth; I have difficulties swallowing certain foods; The skin on my face feels dry; My eyes feel dry; My lips feel dry; The inside of my nose feels dry.
For each of the criteria, patients will also rate the frequency by which having a dry mouth limits their daily functions according to the following description: "never", "hardly ever", "occasionally", "fairly often", "very often"
Measured: At maintenance appointment (1 hour)
The Hygienist Observational Symptom Questionnaire (to assess whether a patient has dry mouth)
The hygienist records the following about their patient using this questionnaire:
- Symptoms of dry mouth identified using the following criteria: patient's initial salivation volume and consistency as copious, adequate, slight, or deficient in volume as well as if the consistency is serous, sticky, or frothy. Best outcome is a copious salivary volume and a saliva consistency that is serous. Worst outcome is a deficient saliva volume and a consistency of saliva that is frothy.
- Record presence of dental caries, enamel demineralization, tooth hypersensitivity, mucositis, oral candidiasis, traumatic gingival ulcerations, fissure tongue, crenulations on tongue, dry lips, angular chelitis, halitosis, food retention on teeth and/or tongue, or loss of papilla on tongue. All listed outcomes would be considered worst outcomes of dry mouth. Patients would benefit from having none of the above.
- Record use of any current treatment for dry mouth.
Measured: At maintenance appointment (1 hour)
Frequency of Periodontal Maintenance Appointment at the Periodontal Clinic and General Dental Clinic
Frequency of periodontal maintenance appointments at the periodontal clinic and general practice will be recorded.
Measured: Will be reviewed from patient's clinical record over a time period of 1 to 5 years (this will represent the time period from recruitment and retrospectively until the time at which sanative therapy was performed)
Frequency of Periodontal Maintenance Appointment only at the Periodontal Clinic
Frequency of periodontal maintenance appointments at the periodontal clinic will be recorded.
Measured: Will be reviewed from patient's clinical record over a time period of 1 to 5 years (this will represent the time period from recruitment and retrospectively until the time at which sanative therapy was performed)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start1 Aug 2018
- Primary completion30 Mar 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal PocketStudies 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
- Retrospective
- Enrolment
- 120 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, PhD, Principal investigator, Brock University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649789
- Sponsor's protocol ID
- 17-387-WARD
- Status last verified
- Dec 2019
- First submitted
- 19 Jul 2018
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Study of Periodontal Outcomes After Sanative Therapy in Patients With or Without Salivary Gland Hypofunction
- ClinicalTrials.gov ID
- NCT03649789
- Acronym / sponsor ID
- 17-387-WARD
- Conditions
- Periodontal Pocket, Xerostomia, Dry Mouth, Periodontal Diseases
- Keywords
- healing, biomarkers, sanative therapy, nutritional supplements, medications, salivary flow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Brock UniversityUniversity, hospital or other
- Collaborators
- Dr. Peter C. Fritz, Periodontal Wellness & Implant Surgery
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 28 Aug 2018 (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.
Salivary gland hypofunction, or dry mouth, is a damaging oral condition that affects salivary gland production. Absence of saliva causes bad breath, dental decay, increased plaque accumulation, dry lips, mouth sores, and the inability to retain dentures or removable protheses. This study will determine if patients with dry mouth have different periodontal health than patients without dry mouth. Additionally, this study will examine if patients who have their periodontal maintenance appointments solely at a periodontal speciality clinic have different periodontal health than patients who alternate their appointments between a specialty office and their general dental office.
Detailed description
Salivary gland hypofunction, or dry mouth, is a damaging oral condition that affects the function and flow rate of saliva. Low saliva rates can range from mild self-reported symptoms and discomfort to significant oral diseases. Saliva is essential in preventing irritation and friction of mucosal surfaces. Progressively dry mouth can cause oral and bodily conditions that can affect an individuals quality of life and daily tasks, such as eating and avoiding social situations. Specifically, dry mouth is a risk factor for periodontal disease, a chronic oral inflammation of tissues and ligaments that support the tooth's structure and if untreated, will ultimately lead to tooth loss. In Canada, the first line of defense against periodontal disease is non-surgical sanative therapy (ST). Participants in this study have been attending a periodontal specialty clinic for routine periodontal maintenance appointments for at least 1 to 5 years following their initial scaling and root planing. Salivary flow rate will be measured to determine the level of dry mouth. At the regular maintenance appointment, clinical measures will be evaluated (probing depth, bleeding on probing, plaque index, gingival index, thickness of tissues, mobility, and furcations). Patients will also complete a dry mouth questionnaire to determine if dry mouth influences the day to day life of a patient, and the patient's Registered Dental Hygienist will complete a short questionnaire outlining oral symptoms of dry mouth. Additionally, the investigators aim to see if a patient who has periodontal maintenance appointments at a specialty office has different clinical outcomes than a patient who alternates these appointments between a specialty office and a general dental office. Overall, the investigators will determine if thorough periodontal maintenance appointments are efficient in preventing periodontal disease in patients with dry mouth.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Salivary Gland Hypofunction | – | –These individuals have an unstimulated salivary flow rate of greater than 0.1 mL saliva/min. |
| Salivary Gland Hypofunction | – | –These individuals have an unstimulated salivary flow rate of less than 0.1 mL saliva/min. |
Who may qualify
- Ages
- 18 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 at this clinic and who have regular maintenance periodontal cleanings on a regular basis at the clinic.
Key inclusion criteria (1 listed)
- have had sanative therapy at this clinic in the previous 1 to 5 years.
Key exclusion criteria (1 listed)
- anyone who is unable to provide informed consent
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
Probing Depth
Time frame: At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
Probing depth is a routine clinical measure of periodontal health (measured in mm)
9 secondary outcomes
Bleeding on Probing
Time frame: At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
O'Leary Index of Plaque Control
Time frame: At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
Gingival Index (used to assess gingival condition to distinguish between the quality of gingiva and the location of gingival concerns).
Time frame: At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards
Thickness of Periodontal Tissue
Time frame: At maintenance appointment (1 hour)
Body Mass Index (BMI)
Time frame: At maintenance appointment (1 hour)
Dry Mouth Inventory Questionnaire Completed by the Patient (to assess impact of dry mouth on quality of life)
Time frame: At maintenance appointment (1 hour)
The Hygienist Observational Symptom Questionnaire (to assess whether a patient has dry mouth)
Time frame: At maintenance appointment (1 hour)
Frequency of Periodontal Maintenance Appointment at the Periodontal Clinic and General Dental Clinic
Time frame: Will be reviewed from patient's clinical record over a time period of 1 to 5 years (this will represent the time period from recruitment and retrospectively until the time at which sanative therapy was performed)
Frequency of Periodontal Maintenance Appointment only at the Periodontal Clinic
Time frame: Will be reviewed from patient's clinical record over a time period of 1 to 5 years (this will represent the time period from recruitment and retrospectively until the time at which sanative therapy was performed)
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 2 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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, PhD principal investigator
Brock University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Pocket and Xerostomia, run by Brock University at 2 sites 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 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Probing Depth (time frame: At maintenance appointment (1 hour) and retrospectively from the clinical record from time of sanative therapy onwards). 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 2 Jan 2020.