- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05656989
GCF PLAP-1, Sclerostin and TNF-α Levels in Periodontitis
Gingival Crevicular Fluid Periodontal Ligament-related Protein-1, Sclerostin and Tumor Necrosis Factor-alfa Levels in Periodontitis
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Aydın, Turkey, 09100
- Adnan Menderes University, Faculty of Dentistry, Department of Periodontology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- no history of smoking (determined by self-reporting)
- had a minimum of 18 natural remaining teeth (excluding third molars).
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
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.
|
Gingivitis
Gingivitis patients exhibited PD ≤ 3 mm and no interproximal CAL or radiographic bone loss.
These patients had BOP ≥ 30% of probe sites.
|
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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
GCF PLAP-1 levels
Time Frame: 24 hours after clinical periodontal measurements
|
ng
|
24 hours after clinical periodontal measurements
|
GCF sclerostin levels
Time Frame: 24 hours after clinical periodontal measurements
|
ng
|
24 hours after clinical periodontal measurements
|
GCF TNF-α levels
Time Frame: 24 hours after clinical periodontal measurements
|
ng
|
24 hours after clinical periodontal measurements
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Timur Köse, İzmir Ege University
- Principal Investigator: Berkay Gür, Aydin Adnan Menderes University
- Principal Investigator: Özge Çevik, Aydin Adnan Menderes University
- Principal Investigator: Gülnur Emingil, İzmir Ege University
- Study Director: Beral Afacan, Aydin Adnan Menderes University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PLAP-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Periodontitis
-
Azienda Socio Sanitaria Territoriale degli Spedali...Università degli Studi di FerraraCompletedPeriodontitis, Aggressive | Periodontitis, AdultItaly
-
Panineeya Mahavidyalaya Institute of Dental Sciences...Research Institute for Genetic and Human TherapyUnknownGeneralized Adult Periodontitis
-
Asem Mohammed Kamel AliCompletedMolar-incisor Pattern Grade C Periodontitis ( Localized Aggressive Periodontitis) | Generalized Grade C Periodontitis (Generalized Aggressive Periodontitis)Egypt
-
Columbia UniversityCompletedPeriodontal Diseases | Generalized Moderate Chronic Periodontitis | Generalized Severe Chronic PeriodontitisUnited States
-
Postgraduate Institute of Dental Sciences RohtakUnknownChronic Apical PeriodontitisIndia
-
University of SienaNot yet recruitingPeriodontitis, AdultItaly
-
Lithuanian University of Health SciencesCompleted
-
Louisiana State University Health Sciences Center...CompletedPeriodontitis, AdultUnited States
-
University of BergenCompletedPeriodontitis | Adult Periodontitis
-
Cairo UniversityUnknownPeriodontitis, AdultEgypt
Clinical Trials on Periodontal clinical measurements and GCF sampling
-
Aydin Adnan Menderes UniversityCompletedPeriodontitis | Gingivitis | Periodontal HealthTurkey
-
Aydin Adnan Menderes UniversityCompletedPeriodontitis | Periodontal InflammationTurkey
-
Gazi UniversityAnkara UniversityCompletedMyocardial Infarction | Chronic Periodontitis
-
Pamukkale UniversityCompletedDiabetes Mellitus, Type 2 | Periodontitis | Coronary Heart Disease | Arterial StiffnessTurkey
-
Dokuz Eylul UniversityCompletedPeriodontitis | Periodontal InflammationTurkey
-
AYSAN LEKTEMUR ALPANCompletedObesity | Periodontal Diseases | GingivitisTurkey
-
Ege UniversityKarolinska InstitutetCompleted
-
Pierre Fabre Dermo CosmetiqueTerminatedDermatitis, AtopicFrance
-
University Hospital, GrenobleTIMC-IMAGCompletedLower Limb Amputation Above Knee (Injury)France
-
Centre Hospitalier Universitaire de NiceNot yet recruitingPemphigoid, Benign Mucous Membrane | Gingivitis HyperplasticFrance