Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 <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

4. 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:

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 <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 Design


Related Conditions & MeSH terms


NCT number NCT04051385
Study type Interventional
Source Abant Izzet Baysal University
Contact
Status Completed
Phase N/A
Start date April 2, 2018
Completion date January 18, 2019

See also
  Status Clinical Trial Phase
Completed NCT04712630 - Non-Incised Papillae Surgical Approach (NIPSA) With and Without Graft N/A
Completed NCT06127069 - Treatment of Residual Pockets in Periodontal Patients Using an Oscillating Chitosan Device N/A
Completed NCT04964167 - Indocyanine-green Mediated Photosensitizer VS Aloe Vera Gel: Adjunct Therapy to Scaling and Root Planing in Patients With Chronic Periodontitis Phase 4
Completed NCT05906797 - Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis. N/A
Recruiting NCT03997552 - NIPSA Versus Marginal Approach by Palatal Incision and MIST in Periodontal Regeneration N/A
Completed NCT05530252 - Effects of AMP Application After Non-surgical Periodontal Therapy on Treatment of Periodontitis Phase 4
Completed NCT04881357 - Antiplaque/Antigingivitis Effect of Lacer Oros Integral N/A
Recruiting NCT03790605 - A Clinical Trial to Study the Effect of a Drug, Curcumin in Patients With Periodontitis Phase 3
Enrolling by invitation NCT04971174 - Outcomes of Periodontal Regenerative Treatment
Not yet recruiting NCT05568290 - Interleukin-38 Levels in Individuals With Periodontitis
Completed NCT04383561 - Relationship Between LRG and Periodontal Disease N/A
Recruiting NCT03997578 - Non-incised Papillae Surgical Approach (NIPSA) and Connective Tissue Graft Plus Emdogain for Periodontal Defects N/A
Completed NCT03901066 - Smoking Dependence and Periodontitis
Enrolling by invitation NCT04956211 - Periodontal Treatment and Ischemic Stroke N/A
Recruiting NCT05971706 - Ozone Application in Periodontal Treatment N/A
Recruiting NCT06099574 - A Study on the Oral Health Status of Pregnant Women With Gestational Diabetes and Its Correlation With Oral Flora
Completed NCT04402996 - Meteorin-like Levels in Individuals With Periodontitis
Active, not recruiting NCT05311657 - Oral Health and Severe COPD
Not yet recruiting NCT06453278 - (DDS) in India: a Screening Tool to Identify Prediabetes and Undiagnosed Type 2 Diabetes in Dental Settings
Not yet recruiting NCT05643287 - The Effect of Time on the Outcome of Periodontal Treatment. N/A