Chronic PeriodontitisNCT02190773
Effect of Surgical Therapy on RANKL/OPG (Osteoprotegerin) System
An observational study of Chronic Periodontitis and Aggressive Periodontitis, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
In the present clinical study including chronic, aggressive periodontitis and healthy individuals, the investigators aimed to determine the RANKL, osteoprotegrin (OPG), Interleukin-1 (IL-1β), IL-10, IL-1β levels in gingival crevicular fluid(GCF) before and after surgical periodontal treatment and search out the… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Periodontitis, Aggressive Periodontitis, RANKL/OPG Ratio
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2010to Apr 2013
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individulas that applied to periodontology clinic in faculty of dentistry, Hacettepe University.
Who may be able to join
- Chronic periodontitis having at least 5mm or more probing depth and aggressive periodontitis patients.
Who cannot join
- Any known systemic disorder, used antibiotics and/or anti-inflammatory medications, had periodontal treatment in the last 3 months and all of them were non smokers. Subjects who were lactating and pregnant were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Surgical Periodontal Therapy on the RANKL/OPG System : Do we Need Osteo-immune Modulation Targeting RANKL?
In the present clinical study including chronic, aggressive periodontitis and healthy individuals, the investigators aimed to determine the RANKL, osteoprotegrin (OPG), Interleukin-1 (IL-1β), IL-10, IL-1β levels in gingival crevicular fluid(GCF) before and after surgical periodontal treatment and search out the relationship of clinical parameters with these cytokine levels.
- Conditions
- Chronic Periodontitis, Aggressive Periodontitis, RANKL/OPG Ratio, Gingival Crevicular Fluid
- Keywords
- Chronic Periodontitis, Aggressive Periodontitis, RANKL/OPG ratio, Gingival crevicular fluid
- Medical subject headings
- Chronic Periodontitis, Aggressive Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic periodontitis | Surgical periodontal treatment and GCF collection 3 months after treatment | |
| Agressive periodontitis | Surgical periodontal treatment and GCF collection 3 months after treatment. | |
| Control group | Periodontally healthy individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
RANKL (pmol) level in GCF
Changes in RANKL levels 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis determined by ELISA
Measured: Baseline-3 months
OPG level (pg) in GCF
Changes in OPG levels 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis determined by ELISA
Measured: Baseline-3 months
RANKL/OPG ratio
RANKL/OPG ratio changes 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis
Measured: Baseline - 3months
Secondary outcomes (2)
IL-1β (pg) levels in GCF
Changes in IL-1β levels (determined by ELISA) 3 months after surgical periodontal treatment in Chronic and Aggressive Periodontitis groups
Measured: Baseline, 3 months after treatment
Il-10 (pg) levels in GCF
Changes in IL-10 levels (determined by ELISA) 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis
Measured: Baseline-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startJan 2010
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ezel Berker, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190773
- Sponsor's protocol ID
- RANKL
- Status last verified
- Jul 2014
- First submitted
- 8 Jul 2014
- Last updated
- 15 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Surgical Periodontal Therapy on the RANKL/OPG System : Do we Need Osteo-immune Modulation Targeting RANKL?
- ClinicalTrials.gov ID
- NCT02190773
- Acronym / sponsor ID
- RANKL
- Conditions
- Chronic Periodontitis, Aggressive Periodontitis, RANKL/OPG Ratio, Gingival Crevicular Fluid
- Keywords
- Chronic Periodontitis, Aggressive Periodontitis, RANKL/OPG ratio, Gingival crevicular fluid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 15 Jul 2014 (estimated)
- 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.
In the present clinical study including chronic, aggressive periodontitis and healthy individuals, the investigators aimed to determine the RANKL, osteoprotegrin (OPG), Interleukin-1 (IL-1β), IL-10, IL-1β levels in gingival crevicular fluid(GCF) before and after surgical periodontal treatment and search out the relationship of clinical parameters with these cytokine levels.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Chronic periodontitis | – | –Surgical periodontal treatment and GCF collection 3 months after treatment |
| Agressive periodontitis | – | –Surgical periodontal treatment and GCF collection 3 months after treatment. |
| Control group | – | –Periodontally healthy individuals |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individulas that applied to periodontology clinic in faculty of dentistry, Hacettepe University.
Key inclusion criteria (1 listed)
- Chronic periodontitis having at least 5mm or more probing depth and aggressive periodontitis patients.
Key exclusion criteria (1 listed)
- Any known systemic disorder, used antibiotics and/or anti-inflammatory medications, had periodontal treatment in the last 3 months and all of them were non smokers. Subjects who were lactating and pregnant were also excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
RANKL (pmol) level in GCF
Time frame: Baseline-3 months
Changes in RANKL levels 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis determined by ELISA
OPG level (pg) in GCF
Time frame: Baseline-3 months
Changes in OPG levels 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis determined by ELISA
RANKL/OPG ratio
Time frame: Baseline - 3months
RANKL/OPG ratio changes 3 months after surgical periodontal treatment in Chronic and Aggressive periodontitis
2 secondary outcomes
IL-1β (pg) levels in GCF
Time frame: Baseline, 3 months after treatment
Il-10 (pg) levels in GCF
Time frame: Baseline-3 months
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 15 Jul 2014.
Related trials for Chronic Periodontitis
Not yet recruiting
Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
Chronic Apical Periodontitis, Pulp Necrosis
Recruiting
Effect of Cyperus Articulatus on Bacterial Reduction and Postoperative Pain
Chronic Apical Periodontitis
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
RecruitingObservational study
Evaluation of Masticatory Performance in Patients With Periodontitis
Periodontitis, Adult, Periodontitis
Recruiting
Postoperative Pain and Success of Single-Visit Root Canal Treatment Using Different Root Canal Sealers in Asymptomatic Teeth
Single-visit, Periapical Periodontitis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Periodontitis and Aggressive Periodontitis, run by Hacettepe University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 15 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
RANKL (pmol) level in GCF (time frame: Baseline-3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jul 2014.