Neurogenic Inflammation in Peri-implant and Periodontal Diseases

Periodontal Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03663140
• Other study ID #: OMU KAEK 2011/752
• Status: Completed
• Start date: January 1, 2011
• Est. completion date: December 30, 2013

Study information

• Verified date: September 2018
• Source: Ondokuz Mayis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 30, 2013
• Est. primary completion date: September 15, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gingival Crevicular Fluid
• Gingival Diseases
• Inflammation
• Neurogenic Inflammation
• Periimplant Diseases
• Periimplant Sulcular Fluid
• Periodontal Diseases

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ondokuz Mayis University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.