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

Umut BALLI

Status and phase: Completed; Early Phase 1

Conditions: Periodontitis

Treatments: Other: non surgical periodontal treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02390479

2013-112-01/10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 25 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups, including a placebo group

Chronic periodontitis

Active Comparator group

Description:

GCF samples were taken before and after treatment chronic periodontitis patients. Intervention: Non- surgical periodontal treatment (SRP and oral hygiene instructions)

Treatment:

Other: non surgical periodontal treatment

clinically healthy periodontium

Placebo Comparator group

Description:

GCF samples were taken at baseline Intervention: oral hygiene instructions

Treatment:

Other: non surgical periodontal treatment