Back to resultsGingival Crevicular Fluid Levels of Sclerostin, Osteoprotegerin (OPG) and RANKL in Health, Disease and After Treatment
Primary Purpose
Periodontitis
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
non surgical periodontal treatment
Sponsored by
About this trial
This is an interventional diagnostic trial for Periodontitis focused on measuring Sclerostin, OPG, RANKL
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Chronic periodontitis
clinically healthy periodontium
Arm Description
GCF samples were taken before and after treatment chronic periodontitis patients. Intervention: Non- surgical periodontal treatment (SRP and oral hygiene instructions)
GCF samples were taken at baseline Intervention: oral hygiene instructions
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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.
Plaque index
The changes in plaque index after periodontal treatment. Plaque index was recorded for determining and classifying oral hygiene status.
Bleeding on probing
The changes in bleeding on probing after periodontal treatment. Bleeding on probing was recorded for classifying and evaluating (apically) gingival inflammation.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02390479
Brief Title
Gingival Crevicular Fluid Levels of Sclerostin, Osteoprotegerin (OPG) and RANKL in Health, Disease and After Treatment
Official Title
Gingival Crevicular Fluid Levels of Sclerostin, Osteoprotegerin (OPG) and RANKL in Health, Disease and After Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Umut BALLI
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
Sclerostin, OPG, RANKL
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Chronic periodontitis
Arm Type
Active Comparator
Arm Description
GCF samples were taken before and after treatment chronic periodontitis patients.
Intervention: Non- surgical periodontal treatment (SRP and oral hygiene instructions)
Arm Title
clinically healthy periodontium
Arm Type
Placebo Comparator
Arm Description
GCF samples were taken at baseline Intervention: oral hygiene instructions
Intervention Type
Other
Intervention Name(s)
non surgical periodontal treatment
Intervention Description
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 Outcome Measure Information:
Title
Biochemical parameters (Sclerostin levels, RANKL/OPG ratio )
Description
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.
Time Frame
Baseline and 6 weeks after treatment
Secondary Outcome Measure Information:
Title
Probing pocket depth
Description
The changes in probing pocket depth after periodontal treatment.Probing pocket depth was measured for determining severity of disease and clinic outcome.
Time Frame
Baseline and 6 weeks after treatment
Title
Probing pocket depth and clinical attachment level
Description
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.
Time Frame
Baseline and 6 weeks after treatment
Title
Gingival index
Description
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.
Time Frame
Baseline and 6 weeks after treatment
Title
Plaque index
Description
The changes in plaque index after periodontal treatment. Plaque index was recorded for determining and classifying oral hygiene status.
Time Frame
Baseline and 6 weeks after treatment
Title
Bleeding on probing
Description
The changes in bleeding on probing after periodontal treatment. Bleeding on probing was recorded for classifying and evaluating (apically) gingival inflammation.
Time Frame
Baseline and 6 weeks after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
12. IPD Sharing Statement
Learn more about this trial
Gingival Crevicular Fluid Levels of Sclerostin, Osteoprotegerin (OPG) and RANKL in Health, Disease and After Treatment
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