Neurogenic Inflammation in Peri-implant and Periodontal Diseases

Sponsor
Ondokuz Mayıs University (Other)
Overall Status
Completed
CT.gov ID
NCT03663140
Collaborator
(none)
39
35.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
39 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Neurogenic Inflammatory Response in Peri-implant and Periodontal Diseases Assessed by Biochemical Analysis of the Neuropeptides in Gingival Crevicular Fluid.
Actual Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Sep 15, 2013
Actual Study Completion Date :
Dec 30, 2013

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Ondokuz Mayıs University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
muge lutfioglu, assoc. prof.dr, Ondokuz Mayıs University
ClinicalTrials.gov Identifier:
NCT03663140
Other Study ID Numbers:
  • OMU KAEK 2011/752
First Posted:
Sep 10, 2018
Last Update Posted:
Sep 13, 2018
Last Verified:
Sep 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 13, 2018