NCT04299477

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2019

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 6, 2020

Completed
Last Updated

March 6, 2020

Status Verified

March 1, 2020

Enrollment Period

9 months

First QC Date

January 22, 2020

Last Update Submit

March 5, 2020

Conditions

OsteoporosisPeriodontitis

Keywords

non-surgical periodontal treatmentbisphosphonatesinterleukin-1βinterleukin-178-hydroxydeoxyguanosinealkaline phosphatase

Outcome Measures

Primary Outcomes (12)

  • salivary levels of IL-1β at baseline

    evaluation of the salivary levels of IL-1β in g/ml

    baseline

  • salivary levels of IL-1β at 1-month

    evaluation of the salivary levels of IL-1β in g/ml

    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

    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

    baseline

  • salivary levels of IL-17 at 1-month

    evaluation of the salivary levels of IL-17 in g/ml

    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

    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

    baseline

  • salivary levels of alkaline phosphatase at 1-month

    evaluation of the salivary levels of alkaline phosphatase in g/ml

    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

    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

    baseline

  • salivary levels of 8-hydroxydeoxyguanosine at 1-month

    evaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml

    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

    3-month follow-up after non-surgical periodontal therapy

Secondary Outcomes (5)

  • Plaque index

    baseline, 1- and 3-month follow- up.

  • gingival index

    baseline, 1- and 3-month follow- up.

  • bleeding on probing

    baseline, 1- and 3-month follow- up.

  • probing depth

    baseline, 1- and 3-month follow- up.

  • clinical attachment level

    baseline, 1- and 3-month follow- up.

Study Arms (3)

Patients with periodontitis and osteoporosis

EXPERIMENTAL

Group 1 : Patients who have periodontitis and osteoporosis prescribed with bisphosphonates

Procedure: non-surgical periodontal treatment

Systemically healthy patients with periodontitis

EXPERIMENTAL

Group 2: Patients who have no systemic diseases but diagnosed as periodontitis

Procedure: non-surgical periodontal treatment

Systemically and periodontally healthy individuals

NO INTERVENTION

Group 3: Healthy controls

Interventions

non-surgical periodontal treatmentPROCEDURE

supra- and subgingival scaling, and root planning

Patients with periodontitis and osteoporosisSystemically healthy patients with periodontitis

Eligibility Criteria

Age35 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Cankaya, 06500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

OsteoporosisPeriodontitis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Basak Karasu

    Gazi University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 22, 2020

First Posted

March 6, 2020

Study Start

June 30, 2018

Primary Completion

March 30, 2019

Study Completion

May 30, 2019

Last Updated

March 6, 2020

Record last verified: 2020-03

Locations

TU(1)