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Completed

NCT Number: NCT03663140

Neurogenic Inflammation in Peri-implant and Periodontal Diseases

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection

Diagnostic Test

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.

Primary outcomes

  1. Gingival crevicular fluid/peri-implant sulcular fluid Level of Substance-P

    Time frame: 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.

  2. Gingival crevicular fluid/peri-implant sulcular fluid Level of neurokinin-A

    Time frame: 8-10 am on the day following periodontal status assessment.

    Neurokinin-A is a neuropeptide of the tachykinin family and marker of neurogenic inflammation.

  3. Gingival crevicular fluid/peri-implant sulcular fluid Level of Calcitonin gene-related peptide

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 10, 2018
Registry last updated
Sep 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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