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Completed

NCT Number: NCT05702892

Evaluation of Bone Metabolism Biomarkers in Periodontal Diseases

This study evaluates the levels of biomarkers associated with bone metabolism in patients with different periodontal conditions.

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Key information

Conditions

Periodontal Diseases Mouth Diseases Periodontitis Sclerosteosis Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Necmettin Erbakan University

Konya, Turkey (Türkiye)

About this study

Background: In this study, the levels of bone metabolism markers found in the saliva of individuals with different periodontal conditions were compared and the relationship of these markers with periodontal status was examined.

Method: A total of 60 individuals, 20 with periodontitis (P), 20 with gingivitis (G), and 20 with periodontal healthy (S), were included in the study. Periodontal clinical parameters (plaque index, gingival index, bleeding on probing, clinical attachment level and probing pocket depth) and saliva samples were obtained from the individuals. Bone metabolism biomarker (necrotizing factor (TNF)-α, osteoprotegerin (OPG), nuclear factor kappa-β receptor activator ligand (RANKL) and sclerostin) levels in saliva samples were evaluated by enzyme-linked immunosorbent assay (ELISA).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 18-65 years old.
  • not having any systemic disease that may affect periodontal status
  • not smoking and alcohol use
  • volunteer to participate in the study

Exclusion criteria

  • periapical pathologies;
  • resulting from orthodontics and occlusion extreme forces, including mechanical forces;
  • chronic high-dose steroid therapy;
  • radiation or immunosuppressive therapy;
  • pregnancy;
  • breastfeeding;
  • allergy or sensitivity to any medication.
  • Periodontal therapy or drug therapy for at least 6 months of study participants

Treatment and study plan

ELISA

Diagnostic Test

ELISA(enzyme-linked immunosorbent assay)

Primary outcomes

  1. Evaluation of bone metabolism biomarkers in different periodontal conditions

    Time frame: baseline

    The levels of bone metabolism markers in the saliva of individuals with different periodontal status were compared and the relationship of these markers with periodontal status was examined.

Secondary outcomes

  1. Probing pocket depth

    Time frame: baseline

    Probing pocket depth(PPD) was measured for determining the severity of the disease and clinical outcome. High probing depth shows more severe periodontal disease.

  2. Gingival index

    Time frame: baseline

    The differences in gingival index scores between periodontally healthy and periodontitis.The gingival index was recorded for determining and classifying gingival status. The gingival index (Gİ) scores each site on a 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling and spontaneous bleeding.

  3. Plaque index

    Time frame: baseline

    The differences in plaque index scores between periodontally healthy and periodontitis. Plaque index (PI) was recorded for determining and classifying oral hygiene status. The plaque index (PI) scores each site on a with 0 being no plaque in gingival area and 3 abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

Evaluation Of Biomarkers Associated With Bone Metabolism İn Patients With Different Periodontal Status

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2023
Registry last updated
Jan 27, 2023

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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