Back to resultsTHE EFFETCS OF NON-SURGICAL PERIODONTAL TREATMENT ON SALIVARY BIOMARKERS OF PATIENTS WITH OSTEOPOROSIS AND PERIODONTITIS
Primary Purpose
Osteoporosis, Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
non-surgical periodontal treatment
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring non-surgical periodontal treatment, bisphosphonates, interleukin-1β, interleukin-17, 8-hydroxydeoxyguanosine, alkaline phosphatase
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Sites / Locations
- Gazi University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Patients with periodontitis and osteoporosis
Systemically healthy patients with periodontitis
Systemically and periodontally healthy individuals
Arm Description
Group 1 : Patients who have periodontitis and osteoporosis prescribed with bisphosphonates
Group 2: Patients who have no systemic diseases but diagnosed as periodontitis
Group 3: Healthy controls
Outcomes
Primary Outcome Measures
salivary levels of IL-1β at baseline
evaluation of the salivary levels of IL-1β in g/ml
salivary levels of IL-1β at 1-month
evaluation of the salivary levels of IL-1β in g/ml
salivary levels of IL-1β at 3-month
evaluation of the salivary levels of IL-1β in g/ml
salivary levels of IL-17 baseline
evaluation of the salivary levels of IL-17 in g/ml
salivary levels of IL-17 at 1-month
evaluation of the salivary levels of IL-17 in g/ml
salivary levels of IL-17 at 3-month
evaluation of the salivary levels of IL-17 in g/ml
salivary levels of alkaline phosphatase at baseline
evaluation of the salivary levels of alkaline phosphatase in g/ml
salivary levels of alkaline phosphatase at 1-month
evaluation of the salivary levels of alkaline phosphatase in g/ml
salivary levels of alkaline phosphatase at 3-month
evaluation of the salivary levels of alkaline phosphatase in g/ml
salivary levels of 8-hydroxydeoxyguanosine at baseline
evaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml
salivary levels of 8-hydroxydeoxyguanosine at 1-month
evaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml
salivary levels of 8-hydroxydeoxyguanosine at 3-month
evaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml
Secondary Outcome Measures
Plaque index
Plaque index scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
gingival index
gingival index scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
bleeding on probing
bleeding on probing scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
probing depth
probing depth scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
clinical attachment level
clinical attachment level scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04299477
Brief Title
THE EFFETCS OF NON-SURGICAL PERIODONTAL TREATMENT ON SALIVARY BIOMARKERS OF PATIENTS WITH OSTEOPOROSIS AND PERIODONTITIS
Official Title
EVALUATION OF THE EFFETCS OF NON-SURGICAL PERIODONTAL TREATMENT ON SALIVARY BIOMARKERS OF PATIENTS UNDERGOING BISPHOSPHONATE THERAPY
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 30, 2018 (Actual)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
May 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gazi University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Periodontitis
Keywords
non-surgical periodontal treatment, bisphosphonates, interleukin-1β, interleukin-17, 8-hydroxydeoxyguanosine, alkaline phosphatase
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with periodontitis and osteoporosis
Arm Type
Experimental
Arm Description
Group 1 : Patients who have periodontitis and osteoporosis prescribed with bisphosphonates
Arm Title
Systemically healthy patients with periodontitis
Arm Type
Experimental
Arm Description
Group 2: Patients who have no systemic diseases but diagnosed as periodontitis
Arm Title
Systemically and periodontally healthy individuals
Arm Type
No Intervention
Arm Description
Group 3: Healthy controls
Intervention Type
Procedure
Intervention Name(s)
non-surgical periodontal treatment
Intervention Description
supra- and subgingival scaling, and root planning
Primary Outcome Measure Information:
Title
salivary levels of IL-1β at baseline
Description
evaluation of the salivary levels of IL-1β in g/ml
Time Frame
baseline
Title
salivary levels of IL-1β at 1-month
Description
evaluation of the salivary levels of IL-1β in g/ml
Time Frame
1-month follow-up after non-surgical periodontal therapy
Title
salivary levels of IL-1β at 3-month
Description
evaluation of the salivary levels of IL-1β in g/ml
Time Frame
3-month follow-up after non-surgical periodontal therapy
Title
salivary levels of IL-17 baseline
Description
evaluation of the salivary levels of IL-17 in g/ml
Time Frame
baseline
Title
salivary levels of IL-17 at 1-month
Description
evaluation of the salivary levels of IL-17 in g/ml
Time Frame
1-month follow-up after non-surgical periodontal therapy
Title
salivary levels of IL-17 at 3-month
Description
evaluation of the salivary levels of IL-17 in g/ml
Time Frame
3-month follow-up after non-surgical periodontal therapy
Title
salivary levels of alkaline phosphatase at baseline
Description
evaluation of the salivary levels of alkaline phosphatase in g/ml
Time Frame
baseline
Title
salivary levels of alkaline phosphatase at 1-month
Description
evaluation of the salivary levels of alkaline phosphatase in g/ml
Time Frame
1-month follow-up after non-surgical periodontal therapy
Title
salivary levels of alkaline phosphatase at 3-month
Description
evaluation of the salivary levels of alkaline phosphatase in g/ml
Time Frame
3-month follow-up after non-surgical periodontal therapy
Title
salivary levels of 8-hydroxydeoxyguanosine at baseline
Description
evaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml
Time Frame
baseline
Title
salivary levels of 8-hydroxydeoxyguanosine at 1-month
Description
evaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml
Time Frame
1-month follow-up after non-surgical periodontal therapy
Title
salivary levels of 8-hydroxydeoxyguanosine at 3-month
Description
evaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml
Time Frame
3-month follow-up after non-surgical periodontal therapy
Secondary Outcome Measure Information:
Title
Plaque index
Description
Plaque index scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
Time Frame
baseline, 1- and 3-month follow- up.
Title
gingival index
Description
gingival index scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
Time Frame
baseline, 1- and 3-month follow- up.
Title
bleeding on probing
Description
bleeding on probing scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
Time Frame
baseline, 1- and 3-month follow- up.
Title
probing depth
Description
probing depth scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
Time Frame
baseline, 1- and 3-month follow- up.
Title
clinical attachment level
Description
clinical attachment level scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
Time Frame
baseline, 1- and 3-month follow- up.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Basak Karasu
Organizational Affiliation
Gazi University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gazi University
City
Ankara
State/Province
Cankaya
ZIP/Postal Code
06500
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
THE EFFETCS OF NON-SURGICAL PERIODONTAL TREATMENT ON SALIVARY BIOMARKERS OF PATIENTS WITH OSTEOPOROSIS AND PERIODONTITIS
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