Impact of Periodontal Treatment on the RANKL/OPG Ratio in Crevicular Fluid
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Valencia
- Enrollment
- 40
- Primary Endpoint
- Levels of RANKL in crevicular fluid
Study Overview
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.
Detailed Description
Material and methods Study design A case-control study was proposed. A group of periodontally healthy subjects was compared to a group of patients with periodontitis before and after scaling and root planing.
Two sites were studied in each subject with periodontitis: one affected site (with periodontitis) and one healthy site (without periodontal disease); the latter site served as a control. Thus, the study units were the healthy and pathological sites before and after SRP treatment.
The masking was triple blind, including the researcher in charge of sample collection, the laboratory technician and the statistician.
Due to the absence of pre-established reference values for the RANKL and OPG concentrations in periodontal health, the results obtained were compared to a control group of subjects with periodontally healthy conditions during the second part of the study.
This protocol was approved by the ethics committee of the University of Valencia (Spain) according to the Declaration of Helsinki. Written informed consent was obtained from the study subjects.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 40 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •The control group included:
- •10 periodontally healthy subjects
- •Without signs or symptoms of periodontal disease.
- •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
- •Pregnant or breastfeeding.
Outcomes
Primary Outcomes
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.
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 Outcomes
- probing depth(49 days)
- clinical attachment level(49 days)
- bleeding upon probing(49 days)
Investigators
Andres Lopez Roldan
Associate professor
University of Valencia