PeriodontitisNCT05656989
GCF PLAP-1, Sclerostin and TNF-α Levels in Periodontitis
An observational study of Periodontitis, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
Trial summary
Periodontal ligament-associated protein-1 (PLAP-1) and sclerostin play an important role in the suppression of bone formation. Tumor necrosis factor-alpha (TNF-α) is an important proinflammatory cytokine involved in periodontal bone loss. Read more about this study
- Who is it for?
- Ages 27 to 46 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontitis
- What is being tested?
- Periodontal clinical measurements and GCF sampling
- How many people
- 71 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2020to 15 Jun 2021
- 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 27 to 46 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: A total of 71 systemically healthy and never-smoker individuals (34 males and 37 females and; aged 27 to 46 years) were consecutively included for this cross-sectional study.
Who may be able to join
- no history of smoking (determined by self-reporting)
- had a minimum of 18 natural remaining teeth (excluding third molars).
Who cannot join
- suffered from diabetes mellitus, rheumatoid arthritis, cardiovascular and respiratory system diseases, hepatic and renal failure, metabolic bone diseases, endocrine disorders, immunologic and mucocutaneous diseases
- used immunosuppressive agents, antibiotics, anti-inflammatory and anti-resorptive drugs, topical antiseptic solutions, calcium channel blockers, beta-blockers, anticoagulants and hormonal contraceptives within the past 3 months
- pregnant or lactating
- received any periodontal intervention in the past year
- used removable partial dentures or orthodontic appliances
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adnan Menderes University, Faculty of Dentistry, Department of Periodontology
Aydin, 09100
About this study
Official title: Gingival Crevicular Fluid Periodontal Ligament-related Protein-1, Sclerostin and Tumor Necrosis Factor-alfa Levels in Periodontitis
Periodontal ligament-associated protein-1 (PLAP-1) and sclerostin play an important role in the suppression of bone formation. Tumor necrosis factor-alpha (TNF-α) is an important proinflammatory cytokine involved in periodontal bone loss. This study aims to investigate gingival crevicular fluid (GCF) PLAP-1, sclerostin and TNF-α levels in individuals with periodontal disease. Totally 71 systemically healthy and non-smoker individuals consisting of stage 3 grade C periodontitis (n=23), gingivitis (n=24) and periodontally healthy (n=24) were enrolled. Periodontal status was evaluated by measuring the full-mouth clinical periodontal parameters. GCF PLAP-1, sclerostin and TNF-α total amounts were measured by ELISA. Data were analyzed using non-parametric statistical tests.
Read the detailed description
According to the clinical and radiographic criteria outlined in the 2017 International Workshop on the Classification of Periodontal and Peri-implant Diseases and Conditions participants were categorized into three distinct groups based upon their periodontal status: 1) 23 patients with stage 3 grade C (S3GC) periodontitis; 2) 24 patients with gingivitis; and 3) 24 periodontally healthy individuals.
Periodontal clinical parameters including probing depth (PD), clinical attachment loss (CAL), the dichotomous recording (present/absent) of bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were recorded at six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual) per tooth, except the third molars.
GCF sampling was performed on the day following periodontal examination. GCF was sampled from the buccal aspects of non-adjacent proximal sites in two single-rooted teeth. Samples were obtained from two deepest pockets in periodontitis group and were taken from the sites with visible signs of inflammation in gingivitis group. GCF samples were collected from sites with no clinical inflammation in the healthy controls. Standardized paper strips were used for GCF sampling. The amount of collected GCF was measured by a precalibrated electronic device.
PLAP-1, sclerostin and TNF-α levels in GCF samples were measured by the enzyme-linked immunosorbent assay (ELISA) via commercial kits, in line with the manufacturer's guidelines. GCF results for three analytes were expressed as total amounts (ng).
All data analyses were carried out using a statistical package. Normality of the clinical and biochemical data was first checked by Shapiro Wilk's normality test. Comparisons of clinical parameters and GCF PLAP-1, sclerostin and TNF-α levels among the study groups were performed using Kruskal-Wallis test, followed by Dunn-Bonferroni post hoc test. The possible correlations of GCF biomarker levels with clinical periodontal parameters and also with each other were determined by Spearman rank correlation analysis.
- Conditions
- Periodontitis
- Being tested
- Periodontal clinical measurements and GCF sampling
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Periodontal clinical measurements and GCF samplingOther
Periodontal clinical parameters measurements probing depth (PD), clinical attachment loss (CAL), the dichotomous recording (present/absent) of bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were recorded at six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual) per tooth, except the third molars using a manual periodontal probe. A sterile paper strip was gently placed into the gingival sulcus/periodontal pocket until mild resistance was sensed and left in place for 30 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Stage 3 Grade C Periodontitis | Generalized S3GC periodontitis patients had PD ≥ 6 mm and interproximal CAL ≥ 5 mm and with radiographic alveolar bone loss extending at least to the middle third of the root at 30 % of the teeth or more. These patients showed no more than four teeth loss due to periodontitis. The percentage bone loss/age values in this group were > 1.0 Receives: Other: Periodontal clinical measurements and GCF sampling | |
| Gingivitis | Gingivitis patients exhibited PD ≤ 3 mm and no interproximal CAL or radiographic bone loss. These patients had BOP ≥ 30% of probe sites. Receives: Other: Periodontal clinical measurements and GCF sampling | |
| Periodontal health | Periodontally healthy controls had an intact periodontium or a reduced periodontium in a non-periodontitis patient (without interproximal CAL or radiographic bone loss). PD was ≤ 3 mm and BOP was < 10 % in this group. Receives: Other: Periodontal clinical measurements and GCF sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
GCF PLAP-1 levels
ng
Measured: 24 hours after clinical periodontal measurements
GCF sclerostin levels
ng
Measured: 24 hours after clinical periodontal measurements
GCF TNF-α levels
ng
Measured: 24 hours after clinical periodontal measurements
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start20 Sep 2020
- Primary completion1 Jun 2021
- Study completion15 Jun 2021
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 PeriodontitisStudies of the same condition, open and under way.
- More trials run by Aydin Adnan Menderes 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
- Cross-sectional
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beral Afacan, Aydin Adnan Menderes University
- Investigators
- Berkay Gür, Principal investigator, Aydin Adnan Menderes UniversityÖzge Çevik, Principal investigator, Aydin Adnan Menderes UniversityTimur Köse, Principal investigator, İzmir Ege UniversityGülnur Emingil, Principal investigator, İzmir Ege UniversityBeral Afacan, Study director, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656989
- Sponsor's protocol ID
- PLAP-1
- Status last verified
- Dec 2022
- First submitted
- 8 Dec 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gur B, Afacan B, Cevik O, Kose T, Emingil G. Gingival crevicular fluid periodontal ligament-associated protein-1, sclerostin, and tumor necrosis factor-alpha levels in periodontitis. J Periodontol. 2023 Oct;94(10):1166-1175. doi: 10.1002/JPER.22-0750. Epub 2023 Apr 19.
PubMed 37006132
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gingival Crevicular Fluid Periodontal Ligament-related Protein-1, Sclerostin and Tumor Necrosis Factor-alfa Levels in Periodontitis
- ClinicalTrials.gov ID
- NCT05656989
- Acronym / sponsor ID
- PLAP-1
- Conditions
- Periodontitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 20 Dec 2022 (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.
Periodontal ligament-associated protein-1 (PLAP-1) and sclerostin play an important role in the suppression of bone formation. Tumor necrosis factor-alpha (TNF-α) is an important proinflammatory cytokine involved in periodontal bone loss. This study aims to investigate gingival crevicular fluid (GCF) PLAP-1, sclerostin and TNF-α levels in individuals with periodontal disease. Totally 71 systemically healthy and non-smoker individuals consisting of stage 3 grade C periodontitis (n=23), gingivitis (n=24) and periodontally healthy (n=24) were enrolled. Periodontal status was evaluated by measuring the full-mouth clinical periodontal parameters. GCF PLAP-1, sclerostin and TNF-α total amounts were measured by ELISA. Data were analyzed using non-parametric statistical tests.
Detailed description
According to the clinical and radiographic criteria outlined in the 2017 International Workshop on the Classification of Periodontal and Peri-implant Diseases and Conditions participants were categorized into three distinct groups based upon their periodontal status: 1) 23 patients with stage 3 grade C (S3GC) periodontitis; 2) 24 patients with gingivitis; and 3) 24 periodontally healthy individuals.
Periodontal clinical parameters including probing depth (PD), clinical attachment loss (CAL), the dichotomous recording (present/absent) of bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were recorded at six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual) per tooth, except the third molars.
GCF sampling was performed on the day following periodontal examination. GCF was sampled from the buccal aspects of non-adjacent proximal sites in two single-rooted teeth. Samples were obtained from two deepest pockets in periodontitis group and were taken from the sites with visible signs of inflammation in gingivitis group. GCF samples were collected from sites with no clinical inflammation in the healthy controls. Standardized paper strips were used for GCF sampling. The amount of collected GCF was measured by a precalibrated electronic device.
PLAP-1, sclerostin and TNF-α levels in GCF samples were measured by the enzyme-linked immunosorbent assay (ELISA) via commercial kits, in line with the manufacturer's guidelines. GCF results for three analytes were expressed as total amounts (ng).
All data analyses were carried out using a statistical package. Normality of the clinical and biochemical data was first checked by Shapiro Wilk's normality test. Comparisons of clinical parameters and GCF PLAP-1, sclerostin and TNF-α levels among the study groups were performed using Kruskal-Wallis test, followed by Dunn-Bonferroni post hoc test. The possible correlations of GCF biomarker levels with clinical periodontal parameters and also with each other were determined by Spearman rank correlation analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stage 3 Grade C Periodontitis | – | Other: Periodontal clinical measurements and GCF samplingGeneralized S3GC periodontitis patients had PD ≥ 6 mm and interproximal CAL ≥ 5 mm and with radiographic alveolar bone loss extending at least to the middle third of the root at 30 % of the teeth or more. These patients showed no more than four teeth loss due to periodontitis. The percentage bone loss/age values in this group were > 1.0 |
| Gingivitis | – | Other: Periodontal clinical measurements and GCF samplingGingivitis patients exhibited PD ≤ 3 mm and no interproximal CAL or radiographic bone loss. These patients had BOP ≥ 30% of probe sites. |
| Periodontal health | – | Other: Periodontal clinical measurements and GCF samplingPeriodontally healthy controls had an intact periodontium or a reduced periodontium in a non-periodontitis patient (without interproximal CAL or radiographic bone loss). PD was ≤ 3 mm and BOP was < 10 % in this group. |
Who may qualify
- Ages
- 27 to 46 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A total of 71 systemically healthy and never-smoker individuals (34 males and 37 females and; aged 27 to 46 years) were consecutively included for this cross-sectional study.
Key inclusion criteria (2 listed)
- no history of smoking (determined by self-reporting)
- had a minimum of 18 natural remaining teeth (excluding third molars).
Key exclusion criteria (5 listed)
- suffered from diabetes mellitus, rheumatoid arthritis, cardiovascular and respiratory system diseases, hepatic and renal failure, metabolic bone diseases, endocrine disorders, immunologic and mucocutaneous diseases
- used immunosuppressive agents, antibiotics, anti-inflammatory and anti-resorptive drugs, topical antiseptic solutions, calcium channel blockers, beta-blockers, anticoagulants and hormonal contraceptives within the past 3 months
- pregnant or lactating
- received any periodontal intervention in the past year
- used removable partial dentures or orthodontic appliances
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 clinical measurements and GCF samplingPeriodontal clinical parameters measurements probing depth (PD), clinical attachment loss (CAL), the dichotomous recording (present/absent) of bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were recorded at six sites (mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual) per tooth, except the third molars using a manual periodontal probe. A sterile paper strip was gently placed into the gingival sulcus/periodontal pocket until mild resistance was sensed and left in place for 30 seconds. | Other | Gingivitis, Periodontal health, Stage 3 Grade C Periodontitis |
Primary outcome
GCF PLAP-1 levels
Time frame: 24 hours after clinical periodontal measurements
ng
GCF sclerostin levels
Time frame: 24 hours after clinical periodontal measurements
ng
GCF TNF-α levels
Time frame: 24 hours after clinical periodontal measurements
ng
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 20 Dec 2022.
- Derived from this study: PubMed 37006132Gur B, Afacan B, Cevik O, Kose T, Emingil G. Gingival crevicular fluid periodontal ligament-associated protein-1, sclerostin, and tumor necrosis factor-alpha levels in periodontitis. J Periodontol. 2023 Oct;94(10):1166-1175. doi: 10.1002/JPER.22-0750. Epub 2023 Apr 19.
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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.
Berkay Gür principal investigator
Aydin Adnan Menderes University
Özge Çevik principal investigator
Aydin Adnan Menderes University
Timur Köse principal investigator
İzmir Ege University
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 Periodontitis, run by Aydin Adnan Menderes 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 2 inclusion and 5 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 20 Dec 2022. 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?
GCF PLAP-1 levels (time frame: 24 hours after clinical periodontal measurements). 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?
On the ClinicalTrials.gov record for NCT05656989, 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 20 Dec 2022.