Neurogenic Inflammation in Peri-implant and Periodontal Diseases
Neurogenic Inflammatory Response in Peri-implant and Periodontal Diseases Assessed by Biochemical Analysis of the Neuropeptides in Gingival Crevicular Fluid.
1 other identifier
observational
39
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2011
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2013
CompletedFirst Submitted
Initial submission to the registry
September 6, 2018
CompletedFirst Posted
Study publicly available on registry
September 10, 2018
CompletedSeptember 13, 2018
September 1, 2018
2.7 years
September 6, 2018
September 11, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
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.
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.
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.
Study Arms (6)
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.
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.
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.
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.
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.
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.
Interventions
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.
Eligibility Criteria
Thirty-nine male, systemically healthy adult individuals (35-55 years old) and 39 dental implants were recruited for the present study. The same implant system was utilized for the treatments and the clinical treatment procedures were completed by the same two clinicians at the Ondokuz Mayis University Dental Faculty between 2011 and 2013.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Biospecimen
gingival crevicular fluid
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 2 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assoc. prof.dr
Study Record Dates
First Submitted
September 6, 2018
First Posted
September 10, 2018
Study Start
January 1, 2011
Primary Completion
September 15, 2013
Study Completion
December 30, 2013
Last Updated
September 13, 2018
Record last verified: 2018-09