Assesment of Gingival Crevicular Fluid and Serum ErbB4/Neuregulin-4 Levels in Periodontal Disease and Health
Assesment of Gingival Crevicular Fluid and Serum ErbB4/Neuregulin-4 Levels in Periodontal Disease and Health
Sponsors
Source
Abant Izzet Baysal University
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Brief Summary
This study aimed to investigate gingival crevicular fluid (GCF) and serum ErbB4 and Nrg4
levels in periodontal health and disease. A total of 80 individuals, 20 patients with stage
II grade B periodontitis, 20 patients with stage III grade B periodontitis, 20 with
gingivitis and 20 periodontally healthy individuals were included. Whole-mouth and
site-specific clinical periodontal parameters including probing depth, clinical attachment
level, bleeding on probing, gingival index, plaque index and papillar bleeding index were
recorded. GCF and serum ErbB4 and Nrg4 levels were measured by enzyme-linked immunosorbent
assay. Statistical analysis was performed by using non-parametric tests.
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:
1. periodontally healthy (H) group: no interproximal attachment loss (AL), probing depth
(PD) ≤3 mm, bleeding on probing (BOP) scores <10%;
2. gingivitis (G) group: no interproximal AL, PD ≤3 mm, and BOP ≥10%;
3. stage II grade B periodontitis (P1) group: 3 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:
1. aged >18 years,
2. having at least 16 natural teeth (excluding third molar),
3. not having any diagnosed medical illness or drug intake that could affect the
periodontal condition.
Exclusion criteria were as follows:
1. The patients who had taken antibiotics, nonsteroidal antiinflammatory or any other drugs
within the past 3 months,
2. received nonsurgical or surgical periodontal treatment,
3. a restorative and endodontic therapy requirement,
4. a removable partial denture and/or having orthodontic therapy
5. 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 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.
Overall Status
Completed
Start Date
2018-04-02
Completion Date
2019-01-18
Primary Completion Date
2019-01-18
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
Biochemical parameters (ErbB4 and Nrg4) |
Baseline and 4 weeks after treatment |
Biochemical parameters (IL-6, IL-10, nitric oxide synthase (NOS) 2 and Arg1) |
Baseline and 4 weeks after treatment |
Secondary Outcome
Measure |
Time Frame |
Probing pocket depth |
Baseline and 4 weeks after treatment |
Clinical attachment loss |
Baseline and 4 weeks after treatment |
Gingival index |
Baseline and 4 weeks after treatment |
Plaque index |
Baseline and 4 weeks after treatment |
Bleeding on probing |
Baseline and 4 weeks after treatment |
Papillar bleeding index |
Baseline and 4 weeks after treatment |
Enrollment
80
Condition
Intervention
Intervention Type
Other
Intervention Name
Description
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.
Arm Group Label
stage II grade B periodontitis
stage III grade B periodontitis
gingivitis
Intervention Type
Other
Intervention Name
Description
GCF with filter paper using the intracrevicular method and serum collection
Arm Group Label
stage II grade B periodontitis
stage III grade B periodontitis
gingivitis
periodontally healthy
Eligibility
Criteria
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 .
Gender
All
Minimum Age
18 Years
Maximum Age
N/A
Healthy Volunteers
Accepts Healthy Volunteers
Overall Official
Last Name |
Role |
Affiliation |
Sadiye Gunpinar, Asst. Prof. |
Principal Investigator |
Abant Izzet Baysal University |
Location
Facility |
Bolu Abant Izzet Baysal University Bolu 14030 Turkey |
Location Countries
Country
Turkey
Verification Date
2019-08-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
Abant Izzet Baysal University
Investigator Full Name
Sadiye Gunpinar
Investigator Title
Asst. Prof.
Keywords
Has Expanded Access
No
Condition Browse
Secondary Id
2018.06.05.1310
Number Of Arms
4
Arm Group
Arm Group Label
stage II grade B periodontitis
Arm Group Type
Active Comparator
Description
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)
Arm Group Label
stage III grade B periodontitis
Arm Group Type
Active Comparator
Description
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)
Arm Group Label
gingivitis
Arm Group Type
Active Comparator
Description
GCF and serum samples were taken before and after treatment from gingivitis patients.
Intervention: Non- surgical periodontal treatment (Scaling and oral hygiene instructions)
Arm Group Label
periodontally healthy
Arm Group Type
Placebo Comparator
Description
GCF and serum samples were taken at baseline from periodontally healthy individuals.
Firstreceived Results Date
N/A
Reference
Citation
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.
PMID
29926951
Citation
G Caton J, Armitage G, Berglundh T, Chapple ILC, Jepsen S, S Kornman K, L Mealey B, Papapanou PN, Sanz M, S Tonetti M. 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.
PMID
29926489
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)
Study First Submitted
August 7, 2019
Study First Submitted Qc
August 7, 2019
Study First Posted
August 9, 2019
Last Update Submitted
August 7, 2019
Last Update Submitted Qc
August 7, 2019
Last Update Posted
August 9, 2019
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.