- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04051385
Assesment of Gingival Crevicular Fluid and Serum ErbB4/Neuregulin-4 Levels in Periodontal Disease and Health
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A total of 80 individuals, comprising 20 patients with stage II grade B periodontitis (P1 Group), 20 patients with stage III grade B periodontitis (P2 Group), 20 patients with gingivitis (G Group), and 20 periodontally healthy controls (H Group) were involved in the study.
The participants were classified into four groups depending on periodontal health status in accordance with the consensus reports of the 2017 World Workshop:
- periodontally healthy (H) group: no interproximal attachment loss (AL), probing depth (PD) ≤3 mm, bleeding on probing (BOP) scores <10%;
- gingivitis (G) group: no interproximal AL, PD ≤3 mm, and BOP ≥10%;
- stage II grade B periodontitis (P1) group: 3 <PD ≤5 mm and 3 ≤ clinical attachment loss (CAL) <5 mm in one or more sites of the 2 non-adjacent teeth in at least two quadrants of the mouth, full mouth BOP ≥ 10% and no tooth loss due to periodontitis
- stage III grade B periodontitis (P2) group: PD >5 mm and CAL ≥ 5 mm in one or more sites of the 2 non-adjacent teeth in at least two quadrants of the mouth, full mouth BOP >10% and tooth loss due to periodontitis of ≤4 teeth.
Inclusion criteria were as follows:
- aged >18 years,
- having at least 16 natural teeth (excluding third molar),
- not having any diagnosed medical illness or drug intake that could affect the periodontal condition.
Exclusion criteria were as follows:
- The patients who had taken antibiotics, nonsteroidal antiinflammatory or any other drugs within the past 3 months,
- received nonsurgical or surgical periodontal treatment,
- a restorative and endodontic therapy requirement,
- a removable partial denture and/or having orthodontic therapy
- Current pregnancy or lactation, obesity, heavy smoking and having serum C reactive protein (CRP) > 3mg/L.
All individuals were examined at baseline and four weeks after non-surgical periodontal treatment including, whole mouth probing depth (PD), CAL, presence of bleeding on probing (BOP), papillar bleeding index (PBI), gingival index (GI) and plaque index (PI) except the third molars. PD and CAL were measured at six sites per tooth using a manual periodontal probe.
The non-surgical periodontal treatment for P1 and P2 groups included supra- and subgingival scaling, root planing and oral hygiene instructions. Subgingival scaling and root planing were performed under local anesthesia in two sessions within the 48-72 h. Gingivitis group had supra-and subgingival scaling, polishing and oral hygiene instructions. The treatment of gingivitis and periodontitis patients were performed by a periodontist (BM) using hand and ultrasonic instruments. All measurements were performed by the same calibrated examiner (BM).
Gingival crevicular fluid (GCF) sampling
GCF samples were obtained from four nonadjacent interproximal sites in two maxillar and two mandibular multi-rooted teeth by standardized filter paper strips. GCF samples were taken from four sites with GI <1, PD ≤ 3, PBI =0 and CAL =0 in the H group; from four sites with GI ≥2, PD ≤3, PBI >2 and CAL=0 in the G group; from four sites (deepest pockets 3 <PD ≤5) with GI ≥2, PBI >2 and 3 ≤CAL <5 mm in P1 group; and from four sites (deepest pockets PD ≥5) with GI ≥2, PBI >2 and CAL ≥5 mm in P2 group according to the baseline clinical measurements.
Serum sampling
Serum samples were taken following GCF sampling before the periodontal treatment. Six milliliters of venous blood were obtained by a standard venipuncture method and the serum was separated from blood by centrifugation at 1,500 g for 20 minutes.
Biochemical Assays
Levels of GCF ErbB4, Nrg4, IL-6, IL-10 and levels of serum ErbB4, Nrg4, nitric oxide synthase (NOS)2 and Arg1 were measured by the enzyme-linked immunosorbent assay (ELISA) using commercial kits according to the manufacturer's guidelines.
Statistical Analysis
All data analyses were performed using a statistical software package. Comparisons of clinical and biochemical parameters between the study groups were performed using the Kruskal- Wallis with Mann Whitney U test with Bonferroni correction method. The intragroup comparisons (at baseline and first month) were performed using Wilcoxon test for paired samples. Associations among levels of the GCF and serum biomarkers and clinical parameters were also examined using the Spearman rank correlation analysis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bolu, Turkey, 14030
- Bolu Abant İzzet Baysal University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Aged >18 years,
- Having at least 16 natural teeth (excluding third molar),
- Not having any diagnosed medical illness or drug intake that could affect the periodontal condition.
Exclusion Criteria:
- Patients who had taken antibiotics, nonsteroidal antiinflammatory or any other drugs within the past 3 months,
- Patients received nonsurgical or surgical periodontal treatment,
- Patients who have a restorative and endodontic therapy requirement,
- Having a removable partial denture and/or having orthodontic therapy,
- Current pregnancy or lactation,
- Obesity,
- Heavy smoking and having serum CRP > 3mg/L .
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: stage II grade B periodontitis
GCF and serum samples were taken before and after treatment from stage II grade B periodontitis patients. Intervention: Non- surgical periodontal treatment (SRP and oral hygiene instructions) |
SRP under local anaesthesia, in a total of 2 clinical visits.
Oral hygiene instructions including the modified Bass technique and an appropriate interdental cleaning device with dental floss and interdental brush.
GCF with filter paper using the intracrevicular method and serum collection
|
ACTIVE_COMPARATOR: stage III grade B periodontitis
GCF and serum samples were taken before and after treatment from stage III grade B periodontitis patients. Intervention: Non- surgical periodontal treatment (SRP and oral hygiene instructions) |
SRP under local anaesthesia, in a total of 2 clinical visits.
Oral hygiene instructions including the modified Bass technique and an appropriate interdental cleaning device with dental floss and interdental brush.
GCF with filter paper using the intracrevicular method and serum collection
|
ACTIVE_COMPARATOR: gingivitis
GCF and serum samples were taken before and after treatment from gingivitis patients. Intervention: Non- surgical periodontal treatment (Scaling and oral hygiene instructions) |
SRP under local anaesthesia, in a total of 2 clinical visits.
Oral hygiene instructions including the modified Bass technique and an appropriate interdental cleaning device with dental floss and interdental brush.
GCF with filter paper using the intracrevicular method and serum collection
|
PLACEBO_COMPARATOR: periodontally healthy
GCF and serum samples were taken at baseline from periodontally healthy individuals.
|
GCF with filter paper using the intracrevicular method and serum collection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biochemical parameters (ErbB4 and Nrg4)
Time Frame: Baseline and 4 weeks after treatment
|
The changes in levels of ErbB4 and Nrg4, four weeks after periodontal treatment determined by ELISA. The changes in levels of ErbB4 and Nrg4 were analyzed to determine as a diagnostic biomarker of periodontal disease. |
Baseline and 4 weeks after treatment
|
Biochemical parameters (IL-6, IL-10, nitric oxide synthase (NOS) 2 and Arg1)
Time Frame: Baseline and 4 weeks after treatment
|
The changes in GCF levels of IL-6 and IL-10 and serum levels of nitric oxide synthase (NOS)2 and Arg1, four weeks after periodontal treatment determined by ELISA.
|
Baseline and 4 weeks after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plaque index
Time Frame: Baseline and 4 weeks after treatment
|
Plaque index was recorded for determining and classifying oral hygiene status
|
Baseline and 4 weeks after treatment
|
Probing pocket depth
Time Frame: Baseline and 4 weeks after treatment
|
The changes in probing pocket depth was measured for determining of the severity of disease and clinical outcome
|
Baseline and 4 weeks after treatment
|
Clinical attachment loss
Time Frame: Baseline and 4 weeks after treatment
|
The changes in clinical attachment loss was measured for determining the severity of disease
|
Baseline and 4 weeks after treatment
|
Gingival index
Time Frame: Baseline and 4 weeks after treatment
|
Gingival index was recorded for classifying and evaluating sulcular gingival inflammation.
Gingival index was also analyzed to detect the relationship between ErbB4/Nrg4 and periodontal disease.
|
Baseline and 4 weeks after treatment
|
Bleeding on probing
Time Frame: Baseline and 4 weeks after treatment
|
Bleeding on probing was recorded for classifying and evaluating gingival inflammation especially for apically sulcular inflammation.
This was also analyzed to detect the relationship between ErbB4/Nrg4 and periodontal disease.
|
Baseline and 4 weeks after treatment
|
Papillar bleeding index
Time Frame: Baseline and 4 weeks after treatment
|
Papillar bleeding index was recorded for classifying and evaluating the papillar gingival inflammation.
This index was also analyzed to detect the relationship between ErbB4/Nrg4 and periodontal disease.
|
Baseline and 4 weeks after treatment
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S173-S182. doi: 10.1002/JPER.17-0721.
- Caton JG, Armitage G, Berglundh T, Chapple ILC, Jepsen S, Kornman KS, Mealey BL, Papapanou PN, Sanz M, Tonetti MS. A new classification scheme for periodontal and peri-implant diseases and conditions - Introduction and key changes from the 1999 classification. J Clin Periodontol. 2018 Jun;45 Suppl 20:S1-S8. doi: 10.1111/jcpe.12935.
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
- 2017/113
- 2018.06.05.1310 (OTHER_GRANT: Bolu Abant Izzet Baysal University Research Foundation)
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
-
Aga Khan UniversityCompletedChronic Apical PeriodontitisPakistan
-
Postgraduate Institute of Dental Sciences RohtakUnknownChronic Apical PeriodontitisIndia
-
University Hospital, Strasbourg, FranceRecruitingPeriodontitis, AdultFrance
-
October University for Modern Sciences and ArtsCompletedPeriodontitis, AdultEgypt
-
Loma Linda UniversityTerminated
-
PiLeJeCompletedProbiotics, PeriodontitisFrance
Clinical Trials on non surgical periodontal treatment
-
Necmettin Erbakan UniversityNot yet recruiting
-
University of CataniaRecruitingAtherosclerosis | Endothelial Dysfunction | Peri-Implantitis | Peri-implant MucositisItaly
-
Malmö UniversitySkane University Hospital; Swedish Dental Service OrganisationRecruitingHeart Diseases | Sepsis | Periodontal Diseases | BacteremiaSweden
-
University of Turin, ItalyCompletedPeriodontitis | Dysbiosis | Intestinal DiseaseItaly
-
Gazi UniversityCompletedSmoking | Periodontitis | Periodontal Diseases | Smoking, TobaccoTurkey
-
University Hospital, Strasbourg, FranceTerminated
-
Universidade Estadual Paulista Júlio de Mesquita...LabviValeCompletedType 2 Diabetes Mellitus With Periodontal DiseaseBrazil
-
National University Health System, SingaporeCompletedPeri-Implantitis | Dental Plaque | Peri-implant MucositisSingapore
-
Mustafa Kemal UniversityCompleted