Neurogenic Inflammation in Peri-implant and Periodontal Diseases

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

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.

Study Overview

• Status: Completed
• Conditions: Periodontal Diseases; Neurogenic Inflammation; Periimplant Diseases; Gingival Crevicular Fluid; Periimplant Sulcular Fluid
• Intervention / Treatment: Diagnostic test: gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection

• Study Type: Observational
• Enrollment (Actual): 39

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Thirty-nine male, systemically healthy adult individuals (35-55 years old) and 39 dental implants were recruited for the present study. The same implant system was utilized for the treatments and the clinical treatment procedures were completed by the same two clinicians at the Ondokuz Mayis University Dental Faculty between 2011 and 2013.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1-Health periodontal; 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; 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.
Group 2- Healthy peri-implant; 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; 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.
group 3- Gingivitis; 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; 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.
Group 4-Peri-implant Mucositis; 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; 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.
Group 5-Periodontitis; 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; 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.
Group 6-Periimplantitis; 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; 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.

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Ondokuz Mayıs University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2011
• Primary Completion (Actual): September 15, 2013
• Study Completion (Actual): December 30, 2013

Study Registration Dates

• First Submitted: September 6, 2018
• First Submitted That Met QC Criteria: September 6, 2018
• First Posted (Actual): September 10, 2018

Study Record Updates

• Last Update Posted (Actual): September 13, 2018
• Last Update Submitted That Met QC Criteria: September 11, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Stomatognathic Diseases; Mouth Diseases; Inflammation; Periodontal Diseases; Neurogenic Inflammation
• Other Study ID Numbers: OMU KAEK 2011/752

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No