Neurogenic Inflammation in Peri-implant and Periodontal Diseases

Study Overview
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Brief Summary
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Regulatory effects of some neuropeptides substance-P (SP), neurokinin-A (NKA), calcitonin gene-linked peptide (CGRP) and neuropeptide-Y (NPY) )on inflammatory responses in periodontal disease has been described; however, the impact of neuropeptide levels are not clearly defined in healthy and diseased peri-implant tissues.ın order to evaluate the situation, thirty-nine implants that have been loaded over the past 12 months and their symmetrically matching teeth were evaluated using a split-mouth study design. Clinical periodontal examinations included the Silness-Löe plaque index, Löe-Silness gingival index, bleeding on probing, probing pocket depth and clinical attachment level parameters were determined. Gingival crevicular fluid (GCF)/Periimplant sulcular fluid (PISF) samples were collected, and the levels of the neuropeptides were determined by enzyme-linked immunosorbent assay. Correlations between GCF/PISF neuropeptide levels and the clinical examination parameters were evaluated in the peri-implant/periodontal soft tissues.

Official Title
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Neurogenic Inflammatory Response in Peri-implant and Periodontal Diseases Assessed by Biochemical Analysis of the Neuropeptides in Gingival Crevicular Fluid.

Conditions
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Neurogenic Inflammation, Periimplant Diseases, Periodontal Diseases, Gingival Crevicular Fluid, Periimplant Sulcular Fluid

Intervention / Treatment
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* Diagnostic Test: gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The main inclusion criteria for patient selection were as follows: Compliance with systematic maintenance care; Adult, non-smoker, systemically healthy Not using any medicament for the last 6 months ; Partially dentated patient treated with implant-supported metal ceramic full crowns and/or fixed partial dentures As the study was split-mouth designed, in each individual at least one implant and one matching tooth in the same mouth symmetrically representing the same tooth group (premolars/molars); A single type of metal ceramic implant restoration that is functional for at least 1 year; and a matching tooth with no dental or endodontic restorations. Exclusion Criteria: Medical history of cancer, rheumatoid arthritis, diabetes mellitus, or cardiovascular disease and any other systemic disease affecting lipid metabolism (i.e. impaired glucose tolerance, metabolic syndrome); Compromised immune system; Pregnancy, menopause, or lactation; Ongoing drug therapy that might affect the clinical characteristics of periodontitis and lipid metabolism; Dental treatment during the 6 months prior to data collection.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1-Health periodontal<br>This group created by individuals with healthy periodontal tissues. Periodontal status/peri-implant was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions. | Diagnostic Test: gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection<br>* GCF/PISF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva.<br>|
| Group 2- Healthy peri-implant<br>This group created by individuals with healthy peri-implant tissues. Periodontal status/peri-implant was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions. | Diagnostic Test: gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection<br>* GCF/PISF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva.<br>|
| group 3- Gingivitis<br>This group created by individuals with gingivitis. Periodontal/peri-implant status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions. | Diagnostic Test: gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection<br>* GCF/PISF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva.<br>|
| Group 4-Peri-implant Mucositis<br>This group created by individuals with peri-implant mucositis. Periodontal/peri-implant status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions. | Diagnostic Test: gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection<br>* GCF/PISF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva.<br>|
| Group 5-Periodontitis<br>This group created by individuals with periodontitis. Periodontal/peri-implant status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions. | Diagnostic Test: gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection<br>* GCF/PISF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva.<br>|
| Group 6-Periimplantitis<br>This group created by individuals with peri-implantitis. Periodontal/peri-implant status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions. | Diagnostic Test: gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection<br>* GCF/PISF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival crevicular fluid/peri-implant sulcular fluid Level of Substance-P | Substance-P (SP) is a neuropeptide of the tachykinin family and marker of neurogenic inflammation. | 8-10 am on the day following periodontal status assessment. | 
| Gingival crevicular fluid/peri-implant sulcular fluid Level of neurokinin-A | Neurokinin-A is a neuropeptide of the tachykinin family and marker of neurogenic inflammation. | 8-10 am on the day following periodontal status assessment. | 
| Gingival crevicular fluid/peri-implant sulcular fluid Level of Calcitonin gene-related peptide | Calcitonin gene-related peptide (CGRP), another neuropeptide derived from peptidergic nerves and a marker of neurogenic inflammation. | 8-10 am on the day following periodontal status assessment. |