Neurogenic Inflammation in Peri-implant and Periodontal Diseases

Completed

• Conditions: Gingival Crevicular Fluid; Periimplant Sulcular Fluid; Neurogenic Inflammation; Periodontal Diseases; Periimplant Diseases
• Interventions: Diagnostic Test: gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection

• Registration Number: NCT03663140
• Lead Sponsor: Ondokuz Mayıs University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2013-09-15
• Study Completion: 2013-12-30
• Status Verified: 2018-09
• Study First Submitted: 2018-09-06
• Study First Submitted QC: 2018-09-06
• Study First Posted: 2018-09-10
• Last Update Submitted: 2018-09-11
• Last Update Posted: 2018-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 39

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1-Health periodontal	gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection	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.
Group 2- Healthy peri-implant	gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection	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.
group 3- Gingivitis	gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection	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.
Group 4-Peri-implant Mucositis	gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection	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.
Group 5-Periodontitis	gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection	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.
Group 6-Periimplantitis	gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection	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.

Primary Outcome Measures

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