Periodontal DiseasesNCT03787875
Impact of Periodontal Treatment on the RANKL/OPG Ratio in Crevicular Fluid
An observational study of Periodontal Diseases and Biomarkers, run by University of Valencia.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Biomarkers, Bone Resorption
- What is being tested?
- periodontal treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2016to 6 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study population is the classic refreshing race of the population of Spain.
Who may be able to join
- -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.
Who cannot join
- 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
Show all 10Show fewer
- Periodontal treatment within the last 6 months
- Orthodontic treatment
- Smoking
- Pregnant or breastfeeding.
About this study
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.
Read the 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.
Sample selection The sample size was determined in relation to the main variable (the RANKL and OPG concentrations); currently, no reference values are available for the concentrations of these parameters under healthy or periodontal disease conditions. Therefore, to determine the sample size, the investigators used the results of previously published studies. Bostanci et al. (2011) and Buduneli et al. (2009) (sample sizes of 27 and 20 subjects, respectively) analysed the concentration changes of these parameters in the CVF before and after basic periodontal treatment.
Therefore, 25 subjects were included in the final sample in our study. The subjects were recruited consecutively at the Periodontics Unit at the Faculty of Medicine and Odontology of the University of Valencia.
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. 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.
The exclusion criteria were as follows: 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; any type of periodontal treatment within the last 6 months; under orthodontic treatment; smoking; and pregnant or breastfeeding.
Periodontal clinical examination:
The examination was performed by only one explorer using a Williams type manual periodontal probe (PQ-OW 208 396, Hu-Friedy®, USA). The probing depth, recession and attachment loss were measured for six sites per tooth. The "Gingival Bleeding Index" of the six sites per tooth was used to assess bleeding upon probing. The Silness and Loe index was used to assess dental plaques.
A complete radiographic series (18 radiographs) was performed for the study group with the ORing paralleling system (Dentsply®) and digital phosphor plates (Durr dental ®). Two bitewing horizontal radiographs were taken in the control group.
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. Four weeks after the last SRP, the patients were examined clinically, and samples of crevicular fluid were collected again.
Study sequence Day 0- Subjects were chosen based on the inclusion and exclusion criteria. Crevicular fluid samples were collected.
Day 7- CVF samples were collected from the selected sites in both groups, and the samples were processed.
Day 14- Periodontal treatment (study group): scaling and root planing of 2 quadrants and provision of oral hygiene instructions.
Day 21- Periodontal treatment (study group): scaling and root planing of the 2 remaining quadrants and provision of oral hygiene instructions.
Day 49- Control group: clinical record and crevicular fluid sample collection and processing.
Collection of crevicular fluid The Periotron® 8000 was calibrated prior to sample collection [27]. In the study group, 4 CVF samples were collected, 2 for each single-rooted tooth with the clinical conditions described above. Two samples from one single-rooted tooth were collected from the control group.
Supragingival plaque was removed with a sterile curette, sluiced, isolated with cotton rolls and dried with air to avoid contamination with saliva. The tip of the Periopaper® was inserted into the sulcus or periodontal pocket until resistance was found and maintained for 30 seconds; tips dyed with blood were discarded. Subsequently, the CVF volume was measured by the Periotron 8000®.
In the following step, each sample was allocated into a sterilised Eppendorf tube with 100 microlitres of buffer containing phosphate-buffered saline (PBS) with protease inhibitors (C.N. P8340 Sigma, MO, USA). The Eppendorf tubes were centrifuged at 15,000 rpm for 5 min; then, another 100 microlitres of buffer was added, and the tubes were centrifuged for 5 min at 15,000 rpm. Finally, 200 microlitres of each sample was stored at -80°C prior to processing.
Sample processing RANKL and OPG were quantified using an enzyme-linked immunosorbent assay (ELISA). The technical specifications of the RANKL (total Human ELISA, BioVendor) and OPG (Bender MedSystems) kits were followed. The total RANKL and OPG concentrations were assessed.
- Conditions
- Periodontal Diseases, Biomarkers, Bone Resorption
- Being tested
- periodontal treatment
- Keywords
- RANKL, OPG, periodontal biomarkers, alveolar bone loss, chronic periodontitis
- Medical subject headings
- Periodontal Diseases, Bone Resorption, Alveolar Bone Loss, Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontal treatmentProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: periodontal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 49 days
Secondary outcomes (3)
probing depth
Probing depth, is the distance from the free gingival margin to the bottom of the periodontal pocket. This parameter will be measured in mm.
Measured: 49 days
clinical attachment level
Is the distance from the free cementoenamel junction to the bottom of the periodontal pocket. This parameter will be measured in mm.
Measured: 49 days
bleeding upon probing
Percentage of points with bleeding on probing in relation to the total number of points probed.
Measured: 49 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2018
- Study start2 Feb 2016
- Primary completion5 Jun 2016
- Study completion6 Nov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andres Lopez Roldan, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03787875
- Sponsor's protocol ID
- UV2
- Status last verified
- Dec 2018
- First submitted
- 21 Dec 2018
- Last updated
- 26 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31986169
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Periodontal Treatment on the RANKL/OPG Ratio in Crevicular Fluid
- ClinicalTrials.gov ID
- NCT03787875
- Acronym / sponsor ID
- UV2
- Conditions
- Periodontal Diseases, Biomarkers, Bone Resorption
- Keywords
- RANKL, OPG, periodontal biomarkers, alveolar bone loss, chronic periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- 2 Feb 2016 (actual)
- Primary completion
- 5 Jun 2016 (actual)
- Study completion
- 6 Nov 2016 (actual)
- First posted
- 26 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Sample selection The sample size was determined in relation to the main variable (the RANKL and OPG concentrations); currently, no reference values are available for the concentrations of these parameters under healthy or periodontal disease conditions. Therefore, to determine the sample size, the investigators used the results of previously published studies. Bostanci et al. (2011) and Buduneli et al. (2009) (sample sizes of 27 and 20 subjects, respectively) analysed the concentration changes of these parameters in the CVF before and after basic periodontal treatment.
Therefore, 25 subjects were included in the final sample in our study. The subjects were recruited consecutively at the Periodontics Unit at the Faculty of Medicine and Odontology of the University of Valencia.
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. 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.
The exclusion criteria were as follows: 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; any type of periodontal treatment within the last 6 months; under orthodontic treatment; smoking; and pregnant or breastfeeding.
Periodontal clinical examination:
The examination was performed by only one explorer using a Williams type manual periodontal probe (PQ-OW 208 396, Hu-Friedy®, USA). The probing depth, recession and attachment loss were measured for six sites per tooth. The "Gingival Bleeding Index" of the six sites per tooth was used to assess bleeding upon probing. The Silness and Loe index was used to assess dental plaques.
A complete radiographic series (18 radiographs) was performed for the study group with the ORing paralleling system (Dentsply®) and digital phosphor plates (Durr dental ®). Two bitewing horizontal radiographs were taken in the control group.
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. Four weeks after the last SRP, the patients were examined clinically, and samples of crevicular fluid were collected again.
Study sequence Day 0- Subjects were chosen based on the inclusion and exclusion criteria. Crevicular fluid samples were collected.
Day 7- CVF samples were collected from the selected sites in both groups, and the samples were processed.
Day 14- Periodontal treatment (study group): scaling and root planing of 2 quadrants and provision of oral hygiene instructions.
Day 21- Periodontal treatment (study group): scaling and root planing of the 2 remaining quadrants and provision of oral hygiene instructions.
Day 49- Control group: clinical record and crevicular fluid sample collection and processing.
Collection of crevicular fluid The Periotron® 8000 was calibrated prior to sample collection [27]. In the study group, 4 CVF samples were collected, 2 for each single-rooted tooth with the clinical conditions described above. Two samples from one single-rooted tooth were collected from the control group.
Supragingival plaque was removed with a sterile curette, sluiced, isolated with cotton rolls and dried with air to avoid contamination with saliva. The tip of the Periopaper® was inserted into the sulcus or periodontal pocket until resistance was found and maintained for 30 seconds; tips dyed with blood were discarded. Subsequently, the CVF volume was measured by the Periotron 8000®.
In the following step, each sample was allocated into a sterilised Eppendorf tube with 100 microlitres of buffer containing phosphate-buffered saline (PBS) with protease inhibitors (C.N. P8340 Sigma, MO, USA). The Eppendorf tubes were centrifuged at 15,000 rpm for 5 min; then, another 100 microlitres of buffer was added, and the tubes were centrifuged for 5 min at 15,000 rpm. Finally, 200 microlitres of each sample was stored at -80°C prior to processing.
Sample processing RANKL and OPG were quantified using an enzyme-linked immunosorbent assay (ELISA). The technical specifications of the RANKL (total Human ELISA, BioVendor) and OPG (Bender MedSystems) kits were followed. The total RANKL and OPG concentrations were assessed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –The control group included 10 periodontally healthy subjects without signs or symptoms of periodontal disease. |
| Study | – | Procedure: periodontal treatmentThe 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. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study population is the classic refreshing race of the population of Spain.
Key inclusion criteria (7 listed)
- -The control group included:
- -The study group included:
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| periodontal treatmentIn 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. | Procedure or surgery | Study |
Primary outcome
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.
3 secondary outcomes
probing depth
Time frame: 49 days
clinical attachment level
Time frame: 49 days
bleeding upon probing
Time frame: 49 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2018.
- Derived from this study: PubMed 31986169Lopez 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases and Biomarkers, run by University of Valencia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Levels of RANKL in crevicular fluid (time frame: 49 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03787875, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2018.