Neurogenic Inflammation in Peri-implant and Periodontal Diseases

NCT ID: NCT03663140

Last Updated: 2018-09-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 39 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-01
• Study Completion Date: 2013-12-30

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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.

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

Intervention Type: 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.

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.

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

Intervention Type: 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.

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.

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

Intervention Type: 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.

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.

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

Intervention Type: 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.

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.

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

Intervention Type: 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.

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.

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

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ondokuz Mayıs University

OTHER

Sponsor Role: lead

Responsible Party

muge lutfioglu

assoc. prof.dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

OMU KAEK 2011/752

Identifier Type: -

Identifier Source: org_study_id