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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02390479
• Other study ID #: 2013-112-01/10
• Status: Completed
• Phase: Phase 0
• First received: February 18, 2015
• Last updated: September 28, 2015
• Start date: December 2013
• Est. completion date: October 2014

Study information

• Verified date: March 2015
• Source: Bulent Ecevit University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 49 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Periodontitis

Intervention

Other:
• non surgical periodontal treatment
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Umut BALLI

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemical parameters (Sclerostin levels, RANKL/OPG ratio )	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.	Baseline and 6 weeks after treatment	Yes
Secondary	Probing pocket depth	The changes in probing pocket depth after periodontal treatment.Probing pocket depth was measured for determining severity of disease and clinic outcome.	Baseline and 6 weeks after treatment	Yes
Secondary	Probing pocket depth and clinical attachment level	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.	Baseline and 6 weeks after treatment	Yes
Secondary	Gingival index	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.	Baseline and 6 weeks after treatment	Yes
Secondary	Plaque index	The changes in plaque index after periodontal treatment. Plaque index was recorded for determining and classifying oral hygiene status.	Baseline and 6 weeks after treatment	Yes
Secondary	Bleeding on probing	The changes in bleeding on probing after periodontal treatment. Bleeding on probing was recorded for classifying and evaluating (apically) gingival inflammation.	Baseline and 6 weeks after treatment	Yes