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THE EFFETCS OF NON-SURGICAL PERIODONTAL TREATMENT ON SALIVARY BIOMARKERS OF PATIENTS WITH OSTEOPOROSIS AND PERIODONTITIS

EVALUATION OF THE EFFETCS OF NON-SURGICAL PERIODONTAL TREATMENT ON SALIVARY BIOMARKERS OF PATIENTS UNDERGOING BISPHOSPHONATE THERAPY

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04299477
Enrollment
75
Registered
2020-03-06
Start date
2018-06-30
Completion date
2019-05-30
Last updated
2020-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis, Periodontitis

Keywords

non-surgical periodontal treatment, bisphosphonates, interleukin-1β, interleukin-17, 8-hydroxydeoxyguanosine, alkaline phosphatase

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.

Interventions

PROCEDUREnon-surgical periodontal treatment

supra- and subgingival scaling, and root planning

Sponsors

Gazi University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
FEMALE
Age
35 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
salivary levels of 8-hydroxydeoxyguanosine at 3-month3-month follow-up after non-surgical periodontal therapyevaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml
salivary levels of IL-17 at 1-month1-month follow-up after non-surgical periodontal therapyevaluation of the salivary levels of IL-17 in g/ml
salivary levels of IL-17 at 3-month3-month follow-up after non-surgical periodontal therapyevaluation of the salivary levels of IL-17 in g/ml
salivary levels of alkaline phosphatase at baselinebaselineevaluation of the salivary levels of alkaline phosphatase in g/ml
salivary levels of 8-hydroxydeoxyguanosine at baselinebaselineevaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml
salivary levels of 8-hydroxydeoxyguanosine at 1-month1-month follow-up after non-surgical periodontal therapyevaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml
salivary levels of IL-1β at baselinebaselineevaluation of the salivary levels of IL-1β in g/ml
salivary levels of IL-1β at 1-month1-month follow-up after non-surgical periodontal therapyevaluation of the salivary levels of IL-1β in g/ml
salivary levels of IL-1β at 3-month3-month follow-up after non-surgical periodontal therapyevaluation of the salivary levels of IL-1β in g/ml
salivary levels of IL-17 baselinebaselineevaluation of the salivary levels of IL-17 in g/ml
salivary levels of alkaline phosphatase at 1-month1-month follow-up after non-surgical periodontal therapyevaluation of the salivary levels of alkaline phosphatase in g/ml
salivary levels of alkaline phosphatase at 3-month3-month follow-up after non-surgical periodontal therapyevaluation of the salivary levels of alkaline phosphatase in g/ml

Secondary

MeasureTime frameDescription
gingival indexbaseline, 1- and 3-month follow- up.gingival index scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
bleeding on probingbaseline, 1- and 3-month follow- up.bleeding on probing scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
probing depthbaseline, 1- and 3-month follow- up.probing depth scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
clinical attachment levelbaseline, 1- and 3-month follow- up.clinical attachment level scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
Plaque indexbaseline, 1- and 3-month follow- up.Plaque index scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026