NCT03787875

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 6, 2016

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 26, 2018

Completed
Last Updated

December 26, 2018

Status Verified

December 1, 2018

Enrollment Period

4 months

First QC Date

December 21, 2018

Last Update Submit

December 24, 2018

Conditions

Keywords

RANKLOPGperiodontal biomarkersalveolar bone losschronic periodontitis

Outcome Measures

Primary Outcomes (2)

  • Levels of RANKL in crevicular fluid

    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.

    49 days

  • Levels of OPG in crevicular fluid

    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.

    49 days

Secondary Outcomes (3)

  • probing depth

    49 days

  • clinical attachment level

    49 days

  • bleeding upon probing

    49 days

Study Arms (2)

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

Interventions

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.

Study

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The study population is the classic refreshing race of the population of Spain.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lopez Roldan A, Garcia Gimenez JL, Alpiste Illueca F. Impact of periodontal treatment on the RANKL/OPG ratio in crevicular fluid. PLoS One. 2020 Jan 27;15(1):e0227757. doi: 10.1371/journal.pone.0227757. eCollection 2020.

MeSH Terms

Conditions

Periodontal DiseasesBone ResorptionAlveolar Bone LossChronic Periodontitis

Interventions

Periodontal Index

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesBone DiseasesMusculoskeletal DiseasesPeriodontal AtrophyPeriodontitisChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Health SurveysHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDentistryPeriodonticsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Dentistry

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 21, 2018

First Posted

December 26, 2018

Study Start

February 2, 2016

Primary Completion

June 5, 2016

Study Completion

November 6, 2016

Last Updated

December 26, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share