Periodontitis Clinical Trial
Official title:
Assesment of Gingival Crevicular Fluid and Serum ErbB4/Neuregulin-4 Levels in Periodontal Disease and Health
Verified date | August 2019 |
Source | Abant Izzet Baysal University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | January 18, 2019 |
Est. primary completion date | January 18, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 . |
Country | Name | City | State |
---|---|---|---|
Turkey | Bolu Abant Izzet Baysal University | Bolu |
Lead Sponsor | Collaborator |
---|---|
Abant Izzet Baysal University |
Turkey,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Biochemical parameters (ErbB4 and Nrg4) | 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 | |
Primary | Biochemical parameters (IL-6, IL-10, nitric oxide synthase (NOS) 2 and Arg1) | 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 | Probing pocket depth | The changes in probing pocket depth was measured for determining of the severity of disease and clinical outcome | Baseline and 4 weeks after treatment | |
Secondary | Clinical attachment loss | The changes in clinical attachment loss was measured for determining the severity of disease | Baseline and 4 weeks after treatment | |
Secondary | Gingival index | 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 | |
Secondary | Plaque index | Plaque index was recorded for determining and classifying oral hygiene status | Baseline and 4 weeks after treatment | |
Secondary | Bleeding on probing | 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 | |
Secondary | Papillar bleeding index | 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 |
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 |