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

March 5, 2020 updated by: Basak Karasu, Gazi University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
75

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Cankaya
      • Ankara, Cankaya, Turkey, 06500
        • Gazi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Patients with periodontitis and osteoporosis
Group 1 : Patients who have periodontitis and osteoporosis prescribed with bisphosphonates
Procedure: non-surgical periodontal treatment
supra- and subgingival scaling, and root planning
Experimental: Systemically healthy patients with periodontitis
Group 2: Patients who have no systemic diseases but diagnosed as periodontitis
Procedure: non-surgical periodontal treatment
supra- and subgingival scaling, and root planning
No Intervention: Systemically and periodontally healthy individuals
Group 3: Healthy controls

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
salivary levels of IL-1β at baseline
Time Frame: baseline
evaluation of the salivary levels of IL-1β in g/ml
baseline
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
1-month follow-up after non-surgical periodontal therapy
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
3-month follow-up after non-surgical periodontal therapy
salivary levels of IL-17 baseline
Time Frame: baseline
evaluation of the salivary levels of IL-17 in g/ml
baseline
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
1-month follow-up after non-surgical periodontal therapy
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
3-month follow-up after non-surgical periodontal therapy
salivary levels of alkaline phosphatase at baseline
Time Frame: baseline
evaluation of the salivary levels of alkaline phosphatase in g/ml
baseline
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
1-month follow-up after non-surgical periodontal therapy
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
3-month follow-up after non-surgical periodontal therapy
salivary levels of 8-hydroxydeoxyguanosine at baseline
Time Frame: baseline
evaluation of the salivary levels of 8-hydroxydeoxyguanosine in g/ml
baseline
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
1-month follow-up after non-surgical periodontal therapy
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
3-month follow-up after non-surgical periodontal therapy

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Plaque index
Time Frame: baseline, 1- and 3-month follow- up.
Plaque index scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
baseline, 1- and 3-month follow- up.
gingival index
Time Frame: baseline, 1- and 3-month follow- up.
gingival index scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
baseline, 1- and 3-month follow- up.
bleeding on probing
Time Frame: baseline, 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
baseline, 1- and 3-month follow- up.
probing depth
Time Frame: baseline, 1- and 3-month follow- up.
probing depth scores assessed at baseline and at 1 month and 3 months after non-surgical periodontal therapy
baseline, 1- and 3-month follow- up.
clinical attachment level
Time Frame: baseline, 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
baseline, 1- and 3-month follow- up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gazi University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Basak Karasu, Gazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 30, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 30, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2018/26120

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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