Periodontal DiseasesNCT05702892
Evaluation of Bone Metabolism Biomarkers in Periodontal Diseases
A study testing ELISA in people with Periodontal Diseases, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluates the levels of biomarkers associated with bone metabolism in patients with different periodontal conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- ELISA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Nov 2020to 5 Nov 2021
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years old.
- not having any systemic disease that may affect periodontal status
- not smoking and alcohol use
- volunteer to participate in the study
Who cannot join
- periapical pathologies;
- resulting from orthodontics and occlusion extreme forces, including mechanical forces;
- chronic high-dose steroid therapy;
- radiation or immunosuppressive therapy;
- pregnancy;
- breastfeeding;
- allergy or sensitivity to any medication.
- Periodontal therapy or drug therapy for at least 6 months of study participants
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Of Biomarkers Associated With Bone Metabolism İn Patients With Different Periodontal Status
This study evaluates the levels of biomarkers associated with bone metabolism in patients with different periodontal conditions.
Read the detailed description
Background: In this study, the levels of bone metabolism markers found in the saliva of individuals with different periodontal conditions were compared and the relationship of these markers with periodontal status was examined.
Method: A total of 60 individuals, 20 with periodontitis (P), 20 with gingivitis (G), and 20 with periodontal healthy (S), were included in the study. Periodontal clinical parameters (plaque index, gingival index, bleeding on probing, clinical attachment level and probing pocket depth) and saliva samples were obtained from the individuals. Bone metabolism biomarker (necrotizing factor (TNF)-α, osteoprotegerin (OPG), nuclear factor kappa-β receptor activator ligand (RANKL) and sclerostin) levels in saliva samples were evaluated by enzyme-linked immunosorbent assay (ELISA).
- Conditions
- Periodontal Diseases
- Being tested
- ELISA
- Keywords
- periodontitis, saliva, sclerostin
- Medical subject headings
- Periodontal Diseases, Periodontitis, Sclerosteosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISADiagnostic test
ELISA(enzyme-linked immunosorbent assay)
| Study group | Role | What they receive |
|---|---|---|
| periodontitis | Experimental | Not described Receives: Diagnostic Test: ELISA |
| gingivitis | Experimental | Not described Receives: Diagnostic Test: ELISA |
| periodontal healthy | Experimental | Not described Receives: Diagnostic Test: ELISA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of bone metabolism biomarkers in different periodontal conditions
The levels of bone metabolism markers in the saliva of individuals with different periodontal status were compared and the relationship of these markers with periodontal status was examined.
Measured: baseline
Secondary outcomes (3)
Probing pocket depth
Probing pocket depth(PPD) was measured for determining the severity of the disease and clinical outcome. High probing depth shows more severe periodontal disease.
Measured: baseline
Gingival index
The differences in gingival index scores between periodontally healthy and periodontitis.The gingival index was recorded for determining and classifying gingival status. The gingival index (Gİ) scores each site on a 0 being normal and 3 being severe inflammation characterized by edema, redness, swelling and spontaneous bleeding.
Measured: baseline
Plaque index
The differences in plaque index scores between periodontally healthy and periodontitis. Plaque index (PI) was recorded for determining and classifying oral hygiene status. The plaque index (PI) scores each site on a with 0 being no plaque in gingival area and 3 abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start5 Nov 2020
- Primary completion5 May 2021
- Study completion5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ummuhan Tekin Atay, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702892
- Sponsor's protocol ID
- Ummuhan.tekinatay
- Status last verified
- Jan 2023
- First submitted
- 9 Jan 2023
- Last updated
- 27 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Biomarkers Associated With Bone Metabolism İn Patients With Different Periodontal Status
- ClinicalTrials.gov ID
- NCT05702892
- Acronym / sponsor ID
- Ummuhan.tekinatay
- Conditions
- Periodontal Diseases
- Keywords
- periodontitis, saliva, sclerostin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- 5 May 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 27 Jan 2023 (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.
This study evaluates the levels of biomarkers associated with bone metabolism in patients with different periodontal conditions.
Detailed description
Background: In this study, the levels of bone metabolism markers found in the saliva of individuals with different periodontal conditions were compared and the relationship of these markers with periodontal status was examined.
Method: A total of 60 individuals, 20 with periodontitis (P), 20 with gingivitis (G), and 20 with periodontal healthy (S), were included in the study. Periodontal clinical parameters (plaque index, gingival index, bleeding on probing, clinical attachment level and probing pocket depth) and saliva samples were obtained from the individuals. Bone metabolism biomarker (necrotizing factor (TNF)-α, osteoprotegerin (OPG), nuclear factor kappa-β receptor activator ligand (RANKL) and sclerostin) levels in saliva samples were evaluated by enzyme-linked immunosorbent assay (ELISA).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| periodontitis | Experimental | Diagnostic Test: ELISA |
| gingivitis | Experimental | Diagnostic Test: ELISA |
| periodontal healthy | Experimental | Diagnostic Test: ELISA |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-65 years old.
- not having any systemic disease that may affect periodontal status
- not smoking and alcohol use
- volunteer to participate in the study
Key exclusion criteria (8 listed)
- periapical pathologies;
- resulting from orthodontics and occlusion extreme forces, including mechanical forces;
- chronic high-dose steroid therapy;
- radiation or immunosuppressive therapy;
- pregnancy;
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 |
|---|---|---|
| ELISAELISA(enzyme-linked immunosorbent assay) | Diagnostic test | gingivitis, periodontal healthy, periodontitis |
Primary outcome
Evaluation of bone metabolism biomarkers in different periodontal conditions
Time frame: baseline
The levels of bone metabolism markers in the saliva of individuals with different periodontal status were compared and the relationship of these markers with periodontal status was examined.
3 secondary outcomes
Probing pocket depth
Time frame: baseline
Gingival index
Time frame: baseline
Plaque index
Time frame: baseline
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 27 Jan 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELISA in people with Periodontal Diseases, run by Necmettin Erbakan 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 4 inclusion and 8 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 27 Jan 2023. 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?
Evaluation of bone metabolism biomarkers in different periodontal conditions (time frame: baseline). 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 27 Jan 2023.