Skip to main content
OpenTrials
Completed

NCT Number: NCT02390479

Gingival Crevicular Fluid Levels of Sclerostin, Osteoprotegerin (OPG) and RANKL in Health, Disease and After Treatment

The primary objective of this case-control intervention study to explore the effectiveness of non surgical periodontal therapy on the gingival crevicular fluid (GCF) levels of sclerostin in patients with chronic periodontitis (CP) so as to get a more detailed insight into its diagnostic and prognostic potential as a biomarker of periodontal disease.

Completed

Looking for future studies?

Notify Me

Key information

Age range

25 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

All individuals underwent a full-mouth periodontal examination, which included probing pocket depth (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), bleeding on probing (BOP). Individuals were categorized into three groups: individuals with clinically healthy periodontium (group 1), patients with chronic periodontitis (group 2), and group 3 consisted of the patients with chronic periodontitis (group 2), treated by scaling and root planning. GCF samples in grup 1 were taken at baseline. In group 2, GCF samples were taken before and after non- surgical periodontal treatment. Sclerostin, OPG and RANKL levels were determined using the enzyme-linked immunosorbent assay.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Criteria for the healthy group were GI = 0, PPD and CAL ≤ 3 mm, and no signs of attachment and bone loss
  • Criteria for the chronic periodontitis group were clinical signs of inflammation, such as red color and swelling of the gingival margin, GI ≥ 2, PPD and CAL ≥ 5 mm with bone loss (>30% of the existing teeth)

Exclusion criteria

  • Aggressive periodontitis, systemic diseases (i.e., diabetes mellitus, cancer, human immunodeficiency virus, bone-related diseases that compromise sclerostin, OPG or RANKL levels and collagen-metabolic diseases, or disorders), chronic high-dose steroid therapy, radiation or immunosuppressive therapy, allergy or sensitivity to any drug, pregnancy, lactation, and current smoking, smoking within the past 5 years. The individuals had no history of periodontal therapy or drug therapy (e.g. anti-inflammatory, antibiotic treatment or any other pharmacological treatment) for at least six months.

Treatment and study plan

non surgical periodontal treatment

Other
  • SRP under local anaesthesia, in a total of four clinical visits
  • Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush.

Primary outcomes

  1. Biochemical parameters (Sclerostin levels, RANKL/OPG ratio )

    Time frame: Baseline and 6 weeks after treatment

    The changes in levels of sclerostin, OPG and RANKL 6 weeks after periodontal treatment determined by ELISA. The changes in levels of sclerostin were analyzed to determine diagnostic and prognostic potential as a biomarker of periodontal disease. The relative RANKL/OPG ratio (bone resorption marker) was also calculated to detect the relationship between sclerostin levels.

Secondary outcomes

  1. Probing pocket depth

    Time frame: Baseline and 6 weeks after treatment

    The changes in probing pocket depth after periodontal treatment.Probing pocket depth was measured for determining severity of disease and clinic outcome.

  2. Probing pocket depth and clinical attachment level

    Time frame: Baseline and 6 weeks after treatment

    The changes in clinical attachment level after periodontal treatment. Clinical attachment level was measured for determining severity of disease and clinic outcome. Also, clinical attachment level was also analyzed to detect the relationship between sclerostin, OPG and RANKL levels.

  3. Gingival index

    Time frame: Baseline and 6 weeks after treatment

    The changes in gingival index after periodontal treatment. Gingival index was recorded for classifying and evaluating (coronally) gingival inflammation. Also, gingival index was also analyzed to detect the relationship between sclerostin, OPG and RANKL levels.

  4. Plaque index

    Time frame: Baseline and 6 weeks after treatment

    The changes in plaque index after periodontal treatment. Plaque index was recorded for determining and classifying oral hygiene status.

  5. Bleeding on probing

    Time frame: Baseline and 6 weeks after treatment

    The changes in bleeding on probing after periodontal treatment. Bleeding on probing was recorded for classifying and evaluating (apically) gingival inflammation.

Sponsors and collaborators

Lead sponsor

Umut BALLI

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 17, 2015
Registry last updated
Sep 30, 2015

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.

Published trials that share one or more normalized conditions with this study.