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NCT Number: NCT04299477

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

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Mouth Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

35 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gazi University

Ankara, Cankaya, 06500, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-surgical periodontal treatment

Procedure

supra- and subgingival scaling, and root planning

Primary outcomes

  1. salivary levels of IL-1β at baseline

    Time frame: baseline

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

  2. 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

  3. 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

  4. salivary levels of IL-17 baseline

    Time frame: baseline

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

  5. 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

  6. 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

  7. salivary levels of alkaline phosphatase at baseline

    Time frame: baseline

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

  8. 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

  9. 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

  10. salivary levels of 8-hydroxydeoxyguanosine at baseline

    Time frame: baseline

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

  11. 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

  12. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Gazi University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 6, 2020
Registry last updated
Mar 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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