Clinical trial NCT04299477: 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
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Periodontitis
Keywords: non-surgical periodontal treatment
bisphosphonates
interleukin-1β
interleukin-17
8-hydroxydeoxyguanosine
alkaline phosphatase
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2020-03-06
Enrollment: 75
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: salivary levels of IL-1β at baseline
timeFrame: baseline
measure: salivary levels of IL-1β at 1-month
timeFrame: 1-month follow-up after non-surgical periodontal therapy
measure: salivary levels of IL-1β at 3-month
timeFrame: 3-month follow-up after non-surgical periodontal therapy
measure: salivary levels of IL-17 baseline
timeFrame: baseline
measure: salivary levels of IL-17 at 1-month
timeFrame: 1-month follow-up after non-surgical periodontal therapy
measure: salivary levels of IL-17 at 3-month
timeFrame: 3-month follow-up after non-surgical periodontal therapy
measure: salivary levels of alkaline phosphatase at baseline
timeFrame: baseline
measure: salivary levels of alkaline phosphatase at 1-month
timeFrame: 1-month follow-up after non-surgical periodontal therapy
measure: salivary levels of alkaline phosphatase at 3-month
timeFrame: 3-month follow-up after non-surgical periodontal therapy
measure: salivary levels of 8-hydroxydeoxyguanosine at baseline
timeFrame: baseline
measure: salivary levels of 8-hydroxydeoxyguanosine at 1-month
timeFrame: 1-month follow-up after non-surgical periodontal therapy
measure: salivary levels of 8-hydroxydeoxyguanosine at 3-month
timeFrame: 3-month follow-up after non-surgical periodontal therapy
Secondary outcomes:
measure: Plaque index
timeFrame: baseline, 1- and 3-month follow- up.
measure: gingival index
timeFrame: baseline, 1- and 3-month follow- up.
measure: bleeding on probing
timeFrame: baseline, 1- and 3-month follow- up.
measure: probing depth
timeFrame: baseline, 1- and 3-month follow- up.
measure: clinical attachment level
timeFrame: baseline, 1- and 3-month follow- up.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
state: Cankaya
Study officials:
affiliation: Gazi University
name: Basak Karasu
role: PRINCIPAL_INVESTIGATOR
References: