Peri-ImplantitisNCT03407911
Microbiota Around Periodontal Teeth and Implants Affected by Peri-implant Disease.
An observational study of Peri-Implantitis and Periodontal Diseases, run by Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele at 1 site in Italy.
Trial summary
The purpose of the study was to evaluate, from a microbiological point of view, microbiota around teeth and implants in the same patient affected by periodontal disease and peri-implant disease, all compared with a healthy tooth. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis, Periodontal Diseases
- What is being tested?
- Harvested
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2018to 1 Jun 2018
- How long will I take part?
- 1 Day
- 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 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: People who received at least one implant loaded for at least one year and affected by peri-implantitis and contemporary present a periodontal tooth and a healthy tooth in own mouth
Who may be able to join
- Implant in service for at least one year without any technical GBR.
- Only Implant inserted on native bone
- Fill out a medical history form and a periodontal board dedicated to the event
Who cannot join
- Post-extractive implant
- Patients in subintrant systemic conditions that contraindicate the insertion of implants
- Patients in the last three months have taken antibiotics or follow any therapy for the resolution of acute events.
- Women who are pregnant or nursing or undergoing hormone therapies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rating Comparative Microbiology of Cell Populations Present Around Teeth Affected by Periodontal Disease and Implants Affected by Peri-implant Disease.
The purpose of the study was to evaluate, from a microbiological point of view, microbiota around teeth and implants in the same patient affected by periodontal disease and peri-implant disease, all compared with a healthy tooth. From the identification of particular bacterial species in the examined sites, it is intended to be traced back to the identification of a clear etiopathogenic process, which may shed light on the similarities and differences between the two diseases. In recognition of these mechanisms, the investigators think to develop new therapeutic strategies for the future.
Read the detailed description
Harvested via sterile paper points, for endodontic use, the sulcular fluid present around a dental element affected by periodontitis, and, in the same patient, the fluid present inside a peri-implant sulcus of a implant affected periimplantitis. If more implants are considered affected by perimplantitis, partecipant will choose the worst as sample site. The same principle will be followed in the case of the tooth affected by periodontal disease. The samples must be underwent to bacterial genomic meta-analysis for the precise identification of bacterial. For a better comparation of the flora, even a healthy tooth from the same patient will be choose like test site and a gingival crevicular fluide will be harvested on it.
The investigators think that the perfect knowledge of the pathogen species is the starter point from a correct therapeutic strategy. But is really important take in mind the individual characteristcs of oral microflora.
The data to be noted at the outset are:
Signs and symptoms of periodontal disease, with precise framing within the Armitage 1999 Classification, and peri-implant disease. For the aim of the study definition of perimplantitis concern an implant with a 4 mm minimal probing depth with bleeding on probing and or suppuration (BOP and Supp) and radiographic bone loss (BL).
Evidence of BL recorded in order of definition of 8th European Consensus Conference of Periodontology Working group 4: BL > 2 mm from the expected bone level if a preliminary rx was absent; Rx 2-3 times the SD of the measurement record (1-1,5 mm) in case a preliminary rx was present.
- Detections diagnostic radiographic and pre-intervention performed with parallel technique (CBCT optional).
- Photographs pre, intra and post op (if present)
- Follow up to 6 months / 1 year (optional) The study provides a GCF harvested around periodontal and peri-implant sulcus in patients recruited for microbiological investigation. The analyzes of the samples are performed "blind". The Probe used is a UNC15 and only one calibrated clinician perform the probing. The pathogen microflora will be compaired with a healthy tooth microflora harvested around a healthy tooth in the same patient.
Pretreatment of the sample sites in order to avoid contamination of the samples by the supragingival bacterial plaque will proceed as follows:
- 2 days prior to sampling, the patient undergoes professional cleaning cups and brushes with the sole purpose of eliminating subgingival plaque. also we will be provided appropriate oral hygiene instruction with brushing twice / day and use of the other instruments where required.
Sampling procedure: The harvested will be carried out through sterile paper point the extent to tip 30 and ISO taper 4%. The sampling technique will be that shown in the figure and marked with the letter c (intracrevicular deep method) until minimum resistance is felt. Each paper point will remain in place for 5 sec, then it will be readily stored in a special sterile container, stored in a refrigerated and delivered within 60 minutes Institute environment that will carry out the examination. Any harvested that show blood contamination will be excluded from the exam.
Microbiological Protocol
- Sample collection and DNA isolation For the metagenomic analysis, samples of paper strip / paper point by patients included in the study, they will be eluted overnight in PBS (phosphate buffered saline) at 4 ° C. Subsequently, the samples will be centrifuged at 10,000 rpm for 15 min at 4 ° C. After removal of the paper point, the supernatant will be used for the extraction of DNA using the QIAamp DNA Mini kit . The DNA will be quantified with Qubit® 2.0 Fluorometer (Thermo Fisher) using QUBIT Kit dsDNA HS ASSAY KIT (Life Technologies).
- Analysis of 16S rRNA - Metagenomics The metagenomic analyzes will be conducted on MiSeq platform Illumina. The gene libraries will be sequenced through the MiSeq v3 reagent kits. The 16S rRNA hypervariable regions will be amplified using a DNA concentration of 5 ng / l with the primers V5-V7.
The libraries will be purified by magnetic beads (AgencourtAmpure XP, Beckman), and the concentration and distribution of the fragments of the libraries will be evaluated on DNA Chip 1000 in the microanalyzer 2100 (Agilent Technologies). The analysis of the sequences (amplicon data sets) and the determination of OTU (OperationalTaxonomicUnits) will be performed by QIIME pipeline using as 16S rRNA gene database Green genes .
Inclusion criteria:
- Assets in service for at least one year without any technical GBR (therefore excluded from the study also post-extraction)
- entered Works on native bone
- Fill out a medical history form and a periodontal board dedicated to the event, as well as a card for the clinician which builds on the work published in J ClinPeriodontol 2012; 39 (Suppl 12): 224-244
- Reporting in the type of system board (optional surgical technique)
Exclusion criteria:
- Patients in subintrant systemic conditions that contraindicate the insertion of implants
- Patients in the last three months, after surgery have taken antibiotics or follow any therapy for the resolution of acute events. The same may qualify for the study later.
- Women who are pregnant or nursing or undergoing hormone therapies
- Conditions
- Peri-Implantitis, Periodontal Diseases
- Being tested
- Harvested
- Keywords
- Peri-implant pocket microbiota, Periodontal pocket microbiota
- Medical subject headings
- Peri-Implantitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HarvestedOther
Metagenomic exam of Gingival crevicular fluid harvested by adsorbent paper point around periodontal teeth and implant affected by peri-implantitis
| Study group | Role | What they receive |
|---|---|---|
| Peri-implant microbiota | Bacterial population in Gingival Intracrevicular fluid harvested with adsorbent paper point Receives: Other: Harvested | |
| Periodontal pocket microbiota | Bacterial population in Gingival Intracrevicular fluid harvested with adsorbent paper point Receives: Other: Harvested | |
| healthy teeth | Bacterial population in Gingival Intracrevicular fluid harvested with adsorbent paper point Receives: Other: Harvested |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant Microbiota
bacterial population around implant affected by peri-implantitis
Measured: 1 day
Secondary outcomes (1)
Microbiota in Peri-implantitis and periodontal disease
Compare the different microbiota around healthy teeth, periodontal teeth and implant affected by peri-implantitis
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start1 Feb 2018
- Primary completion1 Apr 2018
- Study completion1 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni Barbagallo, Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
- Investigators
- Sebastiano Ferlito, Study chair, Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407911
- Sponsor's protocol ID
- Barbagallo Perimplantitis
- Status last verified
- Jan 2020
- First submitted
- 17 Jan 2018
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all data
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rating Comparative Microbiology of Cell Populations Present Around Teeth Affected by Periodontal Disease and Implants Affected by Peri-implant Disease.
- ClinicalTrials.gov ID
- NCT03407911
- Acronym / sponsor ID
- Barbagallo Perimplantitis
- Conditions
- Peri-Implantitis, Periodontal Diseases
- Keywords
- Peri-implant pocket microbiota, Periodontal pocket microbiota
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Azienda Ospedaliera, Universitaria Policlinico Vittorio EmanueleUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Jun 2018 (actual)
- First posted
- 23 Jan 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.
The purpose of the study was to evaluate, from a microbiological point of view, microbiota around teeth and implants in the same patient affected by periodontal disease and peri-implant disease, all compared with a healthy tooth. From the identification of particular bacterial species in the examined sites, it is intended to be traced back to the identification of a clear etiopathogenic process, which may shed light on the similarities and differences between the two diseases. In recognition of these mechanisms, the investigators think to develop new therapeutic strategies for the future.
Detailed description
Harvested via sterile paper points, for endodontic use, the sulcular fluid present around a dental element affected by periodontitis, and, in the same patient, the fluid present inside a peri-implant sulcus of a implant affected periimplantitis. If more implants are considered affected by perimplantitis, partecipant will choose the worst as sample site. The same principle will be followed in the case of the tooth affected by periodontal disease. The samples must be underwent to bacterial genomic meta-analysis for the precise identification of bacterial. For a better comparation of the flora, even a healthy tooth from the same patient will be choose like test site and a gingival crevicular fluide will be harvested on it.
The investigators think that the perfect knowledge of the pathogen species is the starter point from a correct therapeutic strategy. But is really important take in mind the individual characteristcs of oral microflora.
The data to be noted at the outset are:
Signs and symptoms of periodontal disease, with precise framing within the Armitage 1999 Classification, and peri-implant disease. For the aim of the study definition of perimplantitis concern an implant with a 4 mm minimal probing depth with bleeding on probing and or suppuration (BOP and Supp) and radiographic bone loss (BL).
Evidence of BL recorded in order of definition of 8th European Consensus Conference of Periodontology Working group 4: BL > 2 mm from the expected bone level if a preliminary rx was absent; Rx 2-3 times the SD of the measurement record (1-1,5 mm) in case a preliminary rx was present.
- Detections diagnostic radiographic and pre-intervention performed with parallel technique (CBCT optional).
- Photographs pre, intra and post op (if present)
- Follow up to 6 months / 1 year (optional) The study provides a GCF harvested around periodontal and peri-implant sulcus in patients recruited for microbiological investigation. The analyzes of the samples are performed "blind". The Probe used is a UNC15 and only one calibrated clinician perform the probing. The pathogen microflora will be compaired with a healthy tooth microflora harvested around a healthy tooth in the same patient.
Pretreatment of the sample sites in order to avoid contamination of the samples by the supragingival bacterial plaque will proceed as follows:
- 2 days prior to sampling, the patient undergoes professional cleaning cups and brushes with the sole purpose of eliminating subgingival plaque. also we will be provided appropriate oral hygiene instruction with brushing twice / day and use of the other instruments where required.
Sampling procedure: The harvested will be carried out through sterile paper point the extent to tip 30 and ISO taper 4%. The sampling technique will be that shown in the figure and marked with the letter c (intracrevicular deep method) until minimum resistance is felt. Each paper point will remain in place for 5 sec, then it will be readily stored in a special sterile container, stored in a refrigerated and delivered within 60 minutes Institute environment that will carry out the examination. Any harvested that show blood contamination will be excluded from the exam.
Microbiological Protocol
- Sample collection and DNA isolation For the metagenomic analysis, samples of paper strip / paper point by patients included in the study, they will be eluted overnight in PBS (phosphate buffered saline) at 4 ° C. Subsequently, the samples will be centrifuged at 10,000 rpm for 15 min at 4 ° C. After removal of the paper point, the supernatant will be used for the extraction of DNA using the QIAamp DNA Mini kit . The DNA will be quantified with Qubit® 2.0 Fluorometer (Thermo Fisher) using QUBIT Kit dsDNA HS ASSAY KIT (Life Technologies).
- Analysis of 16S rRNA - Metagenomics The metagenomic analyzes will be conducted on MiSeq platform Illumina. The gene libraries will be sequenced through the MiSeq v3 reagent kits. The 16S rRNA hypervariable regions will be amplified using a DNA concentration of 5 ng / l with the primers V5-V7.
The libraries will be purified by magnetic beads (AgencourtAmpure XP, Beckman), and the concentration and distribution of the fragments of the libraries will be evaluated on DNA Chip 1000 in the microanalyzer 2100 (Agilent Technologies). The analysis of the sequences (amplicon data sets) and the determination of OTU (OperationalTaxonomicUnits) will be performed by QIIME pipeline using as 16S rRNA gene database Green genes .
Inclusion criteria:
- Assets in service for at least one year without any technical GBR (therefore excluded from the study also post-extraction)
- entered Works on native bone
- Fill out a medical history form and a periodontal board dedicated to the event, as well as a card for the clinician which builds on the work published in J ClinPeriodontol 2012; 39 (Suppl 12): 224-244
- Reporting in the type of system board (optional surgical technique)
Exclusion criteria:
- Patients in subintrant systemic conditions that contraindicate the insertion of implants
- Patients in the last three months, after surgery have taken antibiotics or follow any therapy for the resolution of acute events. The same may qualify for the study later.
- Women who are pregnant or nursing or undergoing hormone therapies
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Peri-implant microbiota | – | Other: HarvestedBacterial population in Gingival Intracrevicular fluid harvested with adsorbent paper point |
| Periodontal pocket microbiota | – | Other: HarvestedBacterial population in Gingival Intracrevicular fluid harvested with adsorbent paper point |
| healthy teeth | – | Other: HarvestedBacterial population in Gingival Intracrevicular fluid harvested with adsorbent paper point |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- People who received at least one implant loaded for at least one year and affected by peri-implantitis and contemporary present a periodontal tooth and a healthy tooth in own mouth
Key inclusion criteria (3 listed)
- Implant in service for at least one year without any technical GBR.
- Only Implant inserted on native bone
- Fill out a medical history form and a periodontal board dedicated to the event
Key exclusion criteria (4 listed)
- Post-extractive implant
- Patients in subintrant systemic conditions that contraindicate the insertion of implants
- Patients in the last three months have taken antibiotics or follow any therapy for the resolution of acute events.
- Women who are pregnant or nursing or undergoing hormone therapies
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 |
|---|---|---|
| HarvestedMetagenomic exam of Gingival crevicular fluid harvested by adsorbent paper point around periodontal teeth and implant affected by peri-implantitis | Other | Peri-implant microbiota, Periodontal pocket microbiota, healthy teeth |
Primary outcome
Peri-implant Microbiota
Time frame: 1 day
bacterial population around implant affected by peri-implantitis
1 secondary outcome
Microbiota in Peri-implantitis and periodontal disease
Time frame: 1 day
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 9 Jan 2020.
- Individual participant dataSharing planned: Yes. all data
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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.
Sebastiano Ferlito study chair
Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-Implantitis and Periodontal Diseases, run by Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele at 1 site in Italy.
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 3 inclusion and 4 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 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Peri-implant Microbiota (time frame: 1 day). 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 9 Jan 2020.