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

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

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02390479
Enrollment
54
Registered
2015-03-17
Start date
2013-12-31
Completion date
2014-10-31
Last updated
2015-09-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontitis

Keywords

Sclerostin, OPG, RANKL

Brief summary

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.

Detailed description

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.

Interventions

1. SRP under local anaesthesia, in a total of four clinical visits 2. Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush.

Sponsors

Umut BALLI
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
25 Years to 49 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Biochemical parameters (Sclerostin levels, RANKL/OPG ratio )Baseline and 6 weeks after treatmentThe 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

MeasureTime frameDescription
Probing pocket depthBaseline and 6 weeks after treatmentThe changes in probing pocket depth after periodontal treatment.Probing pocket depth was measured for determining severity of disease and clinic outcome.
Probing pocket depth and clinical attachment levelBaseline and 6 weeks after treatmentThe 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.
Gingival indexBaseline and 6 weeks after treatmentThe 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.
Plaque indexBaseline and 6 weeks after treatmentThe changes in plaque index after periodontal treatment. Plaque index was recorded for determining and classifying oral hygiene status.
Bleeding on probingBaseline and 6 weeks after treatmentThe changes in bleeding on probing after periodontal treatment. Bleeding on probing was recorded for classifying and evaluating (apically) gingival inflammation.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026