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

NCT ID: NCT02390479

Last Updated: 2015-09-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Periodontitis

Keywords

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Sclerostin OPG RANKL

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Chronic periodontitis

GCF samples were taken before and after treatment chronic periodontitis patients.

Intervention: Non- surgical periodontal treatment (SRP and oral hygiene instructions)

Group Type ACTIVE_COMPARATOR

non surgical periodontal treatment

Intervention Type 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.

clinically healthy periodontium

GCF samples were taken at baseline Intervention: oral hygiene instructions

Group Type PLACEBO_COMPARATOR

non surgical periodontal treatment

Intervention Type 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.

Interventions

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non surgical periodontal treatment

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

25 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Umut BALLI

OTHER

Sponsor Role lead

Responsible Party

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Umut BALLI

Bulent Ecevit University

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

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2013-112-01/10

Identifier Type: -

Identifier Source: org_study_id