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

NCT02390479 | Completed Early Phase 1

• 1 other identifier: 2013-112-01/10
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Periodontitis

Keywords

Sclerostin; OPG; RANKL

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Probing pocket depth

  Baseline and 6 weeks after treatment

• Probing pocket depth and clinical attachment level

  Baseline and 6 weeks after treatment

• Gingival index

  Baseline and 6 weeks after treatment

• Plaque index

  Baseline and 6 weeks after treatment

• Bleeding on probing

  Baseline and 6 weeks after treatment

Study Arms (2)

Chronic periodontitis

ACTIVE COMPARATOR

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

Other: non surgical periodontal treatment

clinically healthy periodontium

PLACEBO COMPARATOR

GCF samples were taken at baseline Intervention: oral hygiene instructions

Other: non surgical periodontal treatment

Interventions

non surgical periodontal treatment OTHER

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.

Chronic periodontitis; clinically healthy periodontium

Eligibility Criteria

• Age: 25 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Umut BALLI: lead

MeSH Terms

Conditions

Periodontitis; Sclerosteosis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Bulent Ecevit University

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: March 17, 2015
• Study Start: December 1, 2013
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: September 30, 2015

Record last verified: 2015-03