Neurogenic InflammationNCT03663140
Neurogenic Inflammation in Peri-implant and Periodontal Diseases
An observational study of Neurogenic Inflammation and Periimplant Diseases, run by Ondokuz Mayıs University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Neurogenic Inflammation, Periimplant Diseases, Periodontal Diseases
- What is being tested?
- gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 30 Dec 2013
- How long will I take part?
- 2 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Neurogenic Inflammatory Response in Peri-implant and Periodontal Diseases Assessed by Biochemical Analysis of the Neuropeptides in Gingival Crevicular Fluid.
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
- Being tested
- gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection
- Medical subject headings
- Neurogenic Inflammation, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collectionDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection | |
| 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. Receives: Diagnostic Test: gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection | |
| 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. Receives: Diagnostic Test: gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection | |
| 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. Receives: Diagnostic Test: gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection | |
| 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. Receives: Diagnostic Test: gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection | |
| 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. Receives: Diagnostic Test: gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 8-10 am on the day following periodontal status assessment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2018
- Study start1 Jan 2011
- Primary completion15 Sep 2013
- Study completion30 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurogenic InflammationStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 39 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, muge lutfioglu, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03663140
- Sponsor's protocol ID
- OMU KAEK 2011/752
- Status last verified
- Sep 2018
- First submitted
- 6 Sep 2018
- Last updated
- 13 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurogenic Inflammatory Response in Peri-implant and Periodontal Diseases Assessed by Biochemical Analysis of the Neuropeptides in Gingival Crevicular Fluid.
- ClinicalTrials.gov ID
- NCT03663140
- Acronym / sponsor ID
- OMU KAEK 2011/752
- Conditions
- Neurogenic Inflammation, Periimplant Diseases, Periodontal Diseases, Gingival Crevicular Fluid, Periimplant Sulcular Fluid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 15 Sep 2013 (actual)
- Study completion
- 30 Dec 2013 (actual)
- First posted
- 10 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Days
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1-Health periodontal | – | Diagnostic Test: gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collectionThis 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 | – | Diagnostic Test: gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collectionThis 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 | – | Diagnostic Test: gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collectionThis 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 | – | Diagnostic Test: gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collectionThis 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 | – | Diagnostic Test: gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collectionThis 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 | – | Diagnostic Test: gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collectionThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collectionGCF/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. | Diagnostic test | Group 1-Health periodontal, Group 2- Healthy peri-implant, Group 4-Peri-implant Mucositis, Group 5-Periodontitis, Group 6-Periimplantitis, group 3- Gingivitis |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
Related trials for Neurogenic Inflammation
Not yet recruitingObservational study
Biophysical Assessments of Acupuncture Points in Inflammatory Bowel Disease
Inflammatory Bowel Disease (IBD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurogenic Inflammation and Periimplant Diseases, run by Ondokuz Mayıs University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival crevicular fluid/peri-implant sulcular fluid Level of Substance-P (time frame: 8-10 am on the day following periodontal status assessment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2018.