OsteoporosisNCT04299477
THE EFFETCS OF NON-SURGICAL PERIODONTAL TREATMENT ON SALIVARY BIOMARKERS OF PATIENTS WITH OSTEOPOROSIS AND PERIODONTITIS
A study testing non-surgical periodontal treatment in people with Osteoporosis and Periodontitis, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
Inflammatory mediators in periodontitis may lead to elevated systemic cytokine levels, resulting in increased bone resorption including the jaws. Osteoporosis may have an influence on the periodontal condition of post-menopausal women and the risk for periodontal disease may increase due to osteoporosis. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Periodontitis
- What is being tested?
- non-surgical periodontal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2018to 30 May 2019
- 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 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The participants were postmenopausal patients defined as absence of menstruation for at least 12 months.
- Patients with periodontitis;
- Patients who had no systemic diseases and were periodontally healthy (no attachment loss),
- Patients who were treated with oral bisphosphonate at least one year (70 mg tablet once weekly)
Who cannot join
- if they had received any periodontal treatment in the preceding three months,
- if they were pregnant or in the period of lactation,
- if they had systemic diseases that may interfere with normal healing mechanism,
- if they had taken antibiotics, anticonvulsants, immunosuppressants, calcium channel blockers in the preceding six months.
- Smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EVALUATION OF THE EFFETCS OF NON-SURGICAL PERIODONTAL TREATMENT ON SALIVARY BIOMARKERS OF PATIENTS UNDERGOING BISPHOSPHONATE THERAPY
Inflammatory mediators in periodontitis may lead to elevated systemic cytokine levels, resulting in increased bone resorption including the jaws. Osteoporosis may have an influence on the periodontal condition of post-menopausal women and the risk for periodontal disease may increase due to osteoporosis. The hypothesis of the study was that non-surgical periodontal treatment and medical treatment of osteoporosis by bisphosphonates may improve the clinical outcomes and decrease salivary levels of IL-1β, IL-17, ALP and 8-OHdG. Therefore, the aim of this study was to evaluate the mechanism of bi-directional relationship between osteoporosis and periodontal diseases and to investigate the outcomes of non-surgical periodontal treatment with regard to salivary levels of IL-1β, IL-17, 8-OHdG and ALP in patients with periodontitis and osteoporosis.
- Conditions
- Osteoporosis, Periodontitis
- Being tested
- non-surgical periodontal treatment
- Keywords
- non-surgical periodontal treatment, bisphosphonates, interleukin-1β, interleukin-17, 8-hydroxydeoxyguanosine, alkaline phosphatase
- Medical subject headings
- Osteoporosis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-surgical periodontal treatmentProcedure or surgery
supra- and subgingival scaling, and root planning
| Study group | Role | What they receive |
|---|---|---|
| Patients with periodontitis and osteoporosis | Experimental | Group 1 : Patients who have periodontitis and osteoporosis prescribed with bisphosphonates Receives: Procedure: non-surgical periodontal treatment |
| Systemically healthy patients with periodontitis | Experimental | Group 2: Patients who have no systemic diseases but diagnosed as periodontitis Receives: Procedure: non-surgical periodontal treatment |
| Systemically and periodontally healthy individuals | No intervention | Group 3: Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
salivary levels of IL-1β at baseline
evaluation of the salivary levels of IL-1β in g/ml
Measured: baseline
salivary levels of IL-1β at 1-month
evaluation of the salivary levels of IL-1β in g/ml
Measured: 1-month follow-up after non-surgical periodontal therapy
salivary levels of IL-1β at 3-month
evaluation of the salivary levels of IL-1β in g/ml
Measured: 3-month follow-up after non-surgical periodontal therapy
salivary levels of IL-17 baseline
evaluation of the salivary levels of IL-17 in g/ml
Measured: baseline
salivary levels of IL-17 at 1-month
evaluation of the salivary levels of IL-17 in g/ml
Measured: 1-month follow-up after non-surgical periodontal therapy
salivary levels of IL-17 at 3-month
evaluation of the salivary levels of IL-17 in g/ml
Measured: 3-month follow-up after non-surgical periodontal therapy
salivary levels of alkaline phosphatase at baseline
evaluation of the salivary levels of alkaline phosphatase in g/ml
Measured: baseline
salivary levels of alkaline phosphatase at 1-month
evaluation of the salivary levels of alkaline phosphatase in g/ml
Measured: 1-month follow-up after non-surgical periodontal therapy
salivary levels of alkaline phosphatase at 3-month
evaluation of the salivary levels of alkaline phosphatase in g/ml
Measured: 3-month follow-up after non-surgical periodontal therapy
salivary levels of 8-hydroxydeoxyguanosine at baseline
evaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml
Measured: baseline
salivary levels of 8-hydroxydeoxyguanosine at 1-month
evaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml
Measured: 1-month follow-up after non-surgical periodontal therapy
salivary levels of 8-hydroxydeoxyguanosine at 3-month
evaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml
Measured: 3-month follow-up after non-surgical periodontal therapy
Secondary outcomes (5)
Plaque index
Plaque index scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
Measured: baseline, 1- and 3-month follow- up.
gingival index
gingival index scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
Measured: baseline, 1- and 3-month follow- up.
bleeding on probing
bleeding on probing scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
Measured: baseline, 1- and 3-month follow- up.
probing depth
probing depth scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
Measured: baseline, 1- and 3-month follow- up.
clinical attachment level
clinical attachment level scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
Measured: baseline, 1- and 3-month follow- up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2020
- Study start30 Jun 2018
- Primary completion30 Mar 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Gazi UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 25 patients with periodontitis (P) and osteoporosis (group 1), 25 systemically healthy patients with P (group 2) and 25 systemically and periodontally healthy individuals (group 3) were enrolled in this study. Individuals were periodontally examined at baseline, 1 month and 3 months following the non-surgical periodontal therapy. Participants in group 1 and 2 received non-surgical periodontal therapy including supra- and subgingival scaling, and root planning.Patients were advised and instructed to perform oral care twice a day, use interdental toothbrushes once a day regularly. No scaling and root planning was performed in the group 3.
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basak Karasu, Gazi University
- Investigators
- Basak Karasu, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299477
- Sponsor's protocol ID
- 2018/26120
- Other IDs
- 2018
- Status last verified
- Mar 2020
- First submitted
- 22 Jan 2020
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE EFFETCS OF NON-SURGICAL PERIODONTAL TREATMENT ON SALIVARY BIOMARKERS OF PATIENTS UNDERGOING BISPHOSPHONATE THERAPY
- ClinicalTrials.gov ID
- NCT04299477
- Acronym / sponsor ID
- 2018/26120
- Conditions
- Osteoporosis, Periodontitis
- Keywords
- non-surgical periodontal treatment, bisphosphonates, interleukin-1β, interleukin-17, 8-hydroxydeoxyguanosine, alkaline phosphatase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 6 Mar 2020 (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.
Inflammatory mediators in periodontitis may lead to elevated systemic cytokine levels, resulting in increased bone resorption including the jaws. Osteoporosis may have an influence on the periodontal condition of post-menopausal women and the risk for periodontal disease may increase due to osteoporosis. The hypothesis of the study was that non-surgical periodontal treatment and medical treatment of osteoporosis by bisphosphonates may improve the clinical outcomes and decrease salivary levels of IL-1β, IL-17, ALP and 8-OHdG. Therefore, the aim of this study was to evaluate the mechanism of bi-directional relationship between osteoporosis and periodontal diseases and to investigate the outcomes of non-surgical periodontal treatment with regard to salivary levels of IL-1β, IL-17, 8-OHdG and ALP in patients with periodontitis and osteoporosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 25 patients with periodontitis (P) and osteoporosis (group 1), 25 systemically healthy patients with P (group 2) and 25 systemically and periodontally healthy individuals (group 3) were enrolled in this study. Individuals were periodontally examined at baseline, 1 month and 3 months following the non-surgical periodontal therapy. Participants in group 1 and 2 received non-surgical periodontal therapy including supra- and subgingival scaling, and root planning.Patients were advised and instructed to perform oral care twice a day, use interdental toothbrushes once a day regularly. No scaling and root planning was performed in the group 3.
| Arm | Type | Receives |
|---|---|---|
| Patients with periodontitis and osteoporosis | Experimental | Procedure: non-surgical periodontal treatmentGroup 1 : Patients who have periodontitis and osteoporosis prescribed with bisphosphonates |
| Systemically healthy patients with periodontitis | Experimental | Procedure: non-surgical periodontal treatmentGroup 2: Patients who have no systemic diseases but diagnosed as periodontitis |
| Systemically and periodontally healthy individuals | No intervention | –Group 3: Healthy controls |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The participants were postmenopausal patients defined as absence of menstruation for at least 12 months.
- Patients with periodontitis;
- Patients who had no systemic diseases and were periodontally healthy (no attachment loss),
- Patients who were treated with oral bisphosphonate at least one year (70 mg tablet once weekly)
Key exclusion criteria (5 listed)
- if they had received any periodontal treatment in the preceding three months,
- if they were pregnant or in the period of lactation,
- if they had systemic diseases that may interfere with normal healing mechanism,
- if they had taken antibiotics, anticonvulsants, immunosuppressants, calcium channel blockers in the preceding six months.
- Smokers
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 |
|---|---|---|
| non-surgical periodontal treatmentsupra- and subgingival scaling, and root planning | Procedure or surgery | Patients with periodontitis and osteoporosis, Systemically healthy patients with periodontitis |
Primary outcome
salivary levels of IL-1β at baseline
Time frame: baseline
evaluation of the salivary levels of IL-1β in g/ml
salivary levels of IL-1β at 1-month
Time frame: 1-month follow-up after non-surgical periodontal therapy
evaluation of the salivary levels of IL-1β in g/ml
salivary levels of IL-1β at 3-month
Time frame: 3-month follow-up after non-surgical periodontal therapy
evaluation of the salivary levels of IL-1β in g/ml
salivary levels of IL-17 baseline
Time frame: baseline
evaluation of the salivary levels of IL-17 in g/ml
salivary levels of IL-17 at 1-month
Time frame: 1-month follow-up after non-surgical periodontal therapy
evaluation of the salivary levels of IL-17 in g/ml
salivary levels of IL-17 at 3-month
Time frame: 3-month follow-up after non-surgical periodontal therapy
evaluation of the salivary levels of IL-17 in g/ml
salivary levels of alkaline phosphatase at baseline
Time frame: baseline
evaluation of the salivary levels of alkaline phosphatase in g/ml
salivary levels of alkaline phosphatase at 1-month
Time frame: 1-month follow-up after non-surgical periodontal therapy
evaluation of the salivary levels of alkaline phosphatase in g/ml
salivary levels of alkaline phosphatase at 3-month
Time frame: 3-month follow-up after non-surgical periodontal therapy
evaluation of the salivary levels of alkaline phosphatase in g/ml
salivary levels of 8-hydroxydeoxyguanosine at baseline
Time frame: baseline
evaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml
salivary levels of 8-hydroxydeoxyguanosine at 1-month
Time frame: 1-month follow-up after non-surgical periodontal therapy
evaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml
salivary levels of 8-hydroxydeoxyguanosine at 3-month
Time frame: 3-month follow-up after non-surgical periodontal therapy
evaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml
5 secondary outcomes
Plaque index
Time frame: baseline, 1- and 3-month follow- up.
gingival index
Time frame: baseline, 1- and 3-month follow- up.
bleeding on probing
Time frame: baseline, 1- and 3-month follow- up.
probing depth
Time frame: baseline, 1- and 3-month follow- up.
clinical attachment level
Time frame: baseline, 1- and 3-month follow- up.
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 6 Mar 2020.
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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.
Basak Karasu principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-surgical periodontal treatment in people with Osteoporosis and Periodontitis, run by Gazi University at 1 site in Turkey (Türkiye).
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 5 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 6 Mar 2020. 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 Turkey (Türkiye). 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?
salivary levels of IL-1β at baseline (time frame: baseline). The study lists 12 primary outcomes in all. 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 6 Mar 2020.