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Trial record 56 of 231 for:    CALCITONIN SALMON

Neurogenic Inflammation in Peri-implant and Periodontal Diseases

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ClinicalTrials.gov Identifier: NCT03663140
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
muge lutfioglu, Ondokuz Mayıs University

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
Neurogenic Inflammation Periimplant Diseases Periodontal Diseases Gingival Crevicular Fluid Periimplant Sulcular Fluid Diagnostic Test: gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection

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Study Type : Observational [Patient Registry]
Actual Enrollment : 39 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Days
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 : January 1, 2011
Actual Primary Completion Date : September 15, 2013
Actual Study Completion Date : December 30, 2013

Group/Cohort 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.




Primary Outcome Measures :
  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.


Biospecimen Retention:   Samples Without DNA
gingival crevicular fluid


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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.

Additional Information:

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Responsible Party: muge lutfioglu, assoc. prof.dr, Ondokuz Mayıs University
ClinicalTrials.gov Identifier: NCT03663140     History of Changes
Other Study ID Numbers: OMU KAEK 2011/752
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Periodontal Diseases
Neurogenic Inflammation
Inflammation
Pathologic Processes
Mouth Diseases
Stomatognathic Diseases
Neurologic Manifestations
Nervous System Diseases