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Impact of Periodontal Treatment on the RANKL/OPG Ratio in Crevicular Fluid

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ClinicalTrials.gov Identifier: NCT03787875
Recruitment Status : Completed
First Posted : December 25, 2018
Last Update Posted : December 25, 2018
Sponsor:
Information provided by (Responsible Party):
Andres Lopez Roldan, University of Valencia

Brief Summary:

Objectives: Alveolar resorption is one of the most important events in periodontitis. Osteoclast activity is regulated by the ratio between receptor activator of NF-κB ligand (RANKL) and osteoprotegerin (OPG). The aim of this study was to evaluate changes in the RANKL/OPG ratio in crevicular fluid after periodontal treatment.

Material and methods: A total of 15 patients with periodontitis were included in the study group. Samples were collected from an area with active periodontitis and a healthy area. The RANKL and OPG levels were measured before and after periodontal scaling and root planing (SRP) treatment. The study group was compared to the control group, which included 10 patients without periodontitis.


Condition or disease Intervention/treatment
Periodontal Diseases Biomarkers Bone Resorption Procedure: periodontal treatment

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Impact of Periodontal Treatment on the RANKL/OPG Ratio in Crevicular Fluid
Actual Study Start Date : February 2, 2016
Actual Primary Completion Date : June 5, 2016
Actual Study Completion Date : November 6, 2016

Group/Cohort Intervention/treatment
Control
The control group included 10 periodontally healthy subjects without signs or symptoms of periodontal disease.
Study

The study group included 15 subjects diagnosed with mild or advanced chronic periodontitis. Each periodontal patient had one non-affected single-rooted tooth (healthy site) and another single-rooted tooth with periodontitis (periodontitis site) with the following features:

Healthy site: a single-rooted tooth with probing depths below or equal to 3 mm without recession and without bleeding on probing.

Periodontitis site: another single-rooted tooth from the same patient with clinical attachment loss equal to or greater than 6 mm and bleeding upon probing.

Procedure: periodontal treatment
In the study group, periodontal scaling and root planning treatment of the 4 quadrants was performed for two consecutive weeks without the use of antiseptics or antibiotics, and the patients were instructed in oral hygiene, including both brushing techniques and proximal hygiene.




Primary Outcome Measures :
  1. Levels of RANKL in crevicular fluid [ Time Frame: 49 days ]

    receptor activator of NF-κB ligand.RANKL is a protein that determines the activation of osteoclasts by binding to the RANK membrane receptor that preosteoclates possess.

    The ranks wi be measured in μg / μl.


  2. Levels of OPG in crevicular fluid [ Time Frame: 49 days ]

    osteoprotegerin.Osteoprogesterian is a soluble protein that acts as a decoy blocked RANK receptor and thus initiating osteoclastogenesis.

    The opg will be measured in μg / μl.



Secondary Outcome Measures :
  1. probing depth [ Time Frame: 49 days ]
    Probing depth, is the distance from the free gingival margin to the bottom of the periodontal pocket. This parameter will be measured in mm.

  2. clinical attachment level [ Time Frame: 49 days ]
    Is the distance from the free cementoenamel junction to the bottom of the periodontal pocket. This parameter will be measured in mm.

  3. bleeding upon probing [ Time Frame: 49 days ]
    Percentage of points with bleeding on probing in relation to the total number of points probed.



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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study population is the classic refreshing race of the population of Spain.
Criteria

Inclusion Criteria:

  1. -The control group included:

    • 10 periodontally healthy subjects
    • Without signs or symptoms of periodontal disease.
  2. -The study group included:

    • 15 subjects diagnosed with mild or advanced chronic periodontitis.
    • One non-affected single-rooted tooth (healthy site)
    • Single-rooted tooth with periodontitis (periodontitis site) with the following features: with clinical attachment loss equal to or greater than 6 mm and bleeding upon probing.

Exclusion Criteria:

  • Subjects with aggressive periodontitis
  • Systemic diseases or consumption of drugs affecting bone metabolism
  • Antibiotic, anti-inflammatory or contraceptive treatment for the last three months prior to study initiation
  • Antiplatelet therapy for the last 7 days prior to study onset
  • Primary or secondary occlusal trauma
  • Periapical or periodontal abscess in some of the teeth included in the study
  • Periodontal treatment within the last 6 months
  • Orthodontic treatment
  • Smoking
  • Pregnant or breastfeeding.

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Responsible Party: Andres Lopez Roldan, Associate professor, University of Valencia
ClinicalTrials.gov Identifier: NCT03787875     History of Changes
Other Study ID Numbers: UV2
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 25, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andres Lopez Roldan, University of Valencia:
RANKL
OPG
periodontal biomarkers
alveolar bone loss
chronic periodontitis

Additional relevant MeSH terms:
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Bone Resorption
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Bone Diseases
Musculoskeletal Diseases