SensitivityNCT03031392
Sensitivity and Specificity of Peri-Implantitis-Related Parameters
An observational study of Sensitivity and Peri-implant Mucositis, run by Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain at 1 site in Spain.
Trial summary
Bleeding on probing demonstrated to have high specificity with certain level of sensitivity to detect periodontal disease. Again, understanding the weak hemidesmosome attachment to the implant surface is imperative to discern on the probe penetration extent and subsequent bleeding. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sensitivity, Peri-implant Mucositis, Peri-Implantational Loss
- What is being tested?
- Sensitivity test
- How many people
- 141 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2016to 2 Apr 2017
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be either approached during their biannual peri-implant maintenance recall appointment or contacted and asked to participate in a free clinical and radiographic examination to identify the possible presence of peri-implant pathology.
Who may be able to join
- patients within the age range of 18 to 80,
- non- or light smokers (<10cigarettes/day),
- no presence of infectious diseases at the time of implant placement or during the maintenance program,
- no presence of serious disease or condition known to alter bone metabolism,
- partial edentulous patients with stable periodontal condition with or without history of chronic periodontitis.
Who cannot join
- pregnancy,
- history of heavy smoking,
- uncontrolled medical conditions such as diabetes mellitus,
- not adequate implant position (i.e., prosthetically driven),
- not properly restored impeding accurate probing depth recording
- lack of keratinized mucosa
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sensitivity and Specificity of Peri-Implantitis-Related Parameters: A Case-Control Study
Bleeding on probing demonstrated to have high specificity with certain level of sensitivity to detect periodontal disease. Again, understanding the weak hemidesmosome attachment to the implant surface is imperative to discern on the probe penetration extent and subsequent bleeding. In the presence of inflammation, bleeding should be present indicating high sensitivity when probing deeper sites; nevertheless the lack thereof in healthy condition does not seem to translate high specificity. In this sense, it is noteworthy to mention that the mucogingival shift after implant placement often decreases the presence of keratinized mucosa, triggering a greater inflammatory condition on the peri-implant tissues. Thereupon, bleeding on probing, although might reliably indicate presence of disease, it does not seem to be a suitable diagnostic parameter. On the other side, suppuration characterizes the necrosis of peri-implant tissues, being rich in polymorphonuclear cells and as such, a sensitive indicator of bone turnover. In this sense, it must be noted that, if detected in early stages where bone resorption has not occurred yet, it might be a consequence of a foreign body reaction (i.e., residual cement or floss).
Therefore, in the diagnosis of peri-implantitis, radiographic examination must be always incorporated to the clinical assessment as the 'gold standard'. Hence, the aim of this case-control study was to assess the diagnostic accuracy of peri-implantitis-related clinical parameters compared to otherwise healthy dental implants.
Read the detailed description
All subjects enrolled had to be consecutively evaluated in a routine peri-implant maintenance t with dental implants for fixed prosthesis rehabilitation with a minimum period of 12 months after final prosthesis delivery. Patients were contacted and informed to participate in a cross-sectional assessment to identify the presence of peri-implant diseases. Eligible implants had to be in an ideal prosthetically driven position, otherwise they were excluded from the analysis. Moreover, implants that could not be accurately recorded the probing depth due to inadequate prosthesis design were further excluded. Baseline periapical x-ray at time of prosthesis delivery was retrospective assessed to exclude implants with early peri-implant bone loss before function. A detailed description of risk factors and indicators of peri-implant disease were explained at the same stage. Additionally, patients were thoroughly instructed on plaque control home care strategies including but not limited to interdental brushes with nylon-coated core wire, soft toothbrushes (manual and power) and floss with stiffened end to clean under multiple units fixed-prosthesis. Moreover, treated patients were encouraged to routinely enroll in a peri-implant maintenance therapy program.
The present case-control study will be conducted in accordance with the Helsinki declaration of human studies and received approval from the ethics committee from the University of Extremadura (Badajoz, Spain). An informed written consent was signed from each subject enrolled in the present study.
- Being tested
- Sensitivity test
- Medical subject headings
- Hypersensitivity, Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensitivity testDiagnostic test
Routine clinical and radiographic examination
| Study group | Role | What they receive |
|---|---|---|
| Peri-implantitis | Individuals with implants ≥2mm of radiographic bone loss Receives: Diagnostic Test: Sensitivity test | |
| non-peri-implantitis patients | Individuals with implants <2mm of radiographic bone loss Receives: Diagnostic Test: Sensitivity test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity to detect peri-implantitis
Capability to diagnose disease
Measured: 1 year
Specificity to detect peri-implantitis
Capability to diagnose health
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study start1 Jul 2016
- Primary completion1 Apr 2017
- Study completion2 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SensitivityStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florencio Monje Gil, Study director, Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031392
- Sponsor's protocol ID
- 18002909/3
- Status last verified
- Jan 2017
- First submitted
- 20 Jan 2017
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity and Specificity of Peri-Implantitis-Related Parameters: A Case-Control Study
- ClinicalTrials.gov ID
- NCT03031392
- Acronym / sponsor ID
- 18002909/3
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, SpainUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 2 Apr 2017 (actual)
- First posted
- 25 Jan 2017 (estimated)
- 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.
Bleeding on probing demonstrated to have high specificity with certain level of sensitivity to detect periodontal disease. Again, understanding the weak hemidesmosome attachment to the implant surface is imperative to discern on the probe penetration extent and subsequent bleeding. In the presence of inflammation, bleeding should be present indicating high sensitivity when probing deeper sites; nevertheless the lack thereof in healthy condition does not seem to translate high specificity. In this sense, it is noteworthy to mention that the mucogingival shift after implant placement often decreases the presence of keratinized mucosa, triggering a greater inflammatory condition on the peri-implant tissues. Thereupon, bleeding on probing, although might reliably indicate presence of disease, it does not seem to be a suitable diagnostic parameter. On the other side, suppuration characterizes the necrosis of peri-implant tissues, being rich in polymorphonuclear cells and as such, a sensitive indicator of bone turnover. In this sense, it must be noted that, if detected in early stages where bone resorption has not occurred yet, it might be a consequence of a foreign body reaction (i.e., residual cement or floss).
Therefore, in the diagnosis of peri-implantitis, radiographic examination must be always incorporated to the clinical assessment as the 'gold standard'. Hence, the aim of this case-control study was to assess the diagnostic accuracy of peri-implantitis-related clinical parameters compared to otherwise healthy dental implants.
Detailed description
All subjects enrolled had to be consecutively evaluated in a routine peri-implant maintenance t with dental implants for fixed prosthesis rehabilitation with a minimum period of 12 months after final prosthesis delivery. Patients were contacted and informed to participate in a cross-sectional assessment to identify the presence of peri-implant diseases. Eligible implants had to be in an ideal prosthetically driven position, otherwise they were excluded from the analysis. Moreover, implants that could not be accurately recorded the probing depth due to inadequate prosthesis design were further excluded. Baseline periapical x-ray at time of prosthesis delivery was retrospective assessed to exclude implants with early peri-implant bone loss before function. A detailed description of risk factors and indicators of peri-implant disease were explained at the same stage. Additionally, patients were thoroughly instructed on plaque control home care strategies including but not limited to interdental brushes with nylon-coated core wire, soft toothbrushes (manual and power) and floss with stiffened end to clean under multiple units fixed-prosthesis. Moreover, treated patients were encouraged to routinely enroll in a peri-implant maintenance therapy program.
The present case-control study will be conducted in accordance with the Helsinki declaration of human studies and received approval from the ethics committee from the University of Extremadura (Badajoz, Spain). An informed written consent was signed from each subject enrolled in the present study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peri-implantitis | – | Diagnostic Test: Sensitivity testIndividuals with implants ≥2mm of radiographic bone loss |
| non-peri-implantitis patients | – | Diagnostic Test: Sensitivity testIndividuals with implants <2mm of radiographic bone loss |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be either approached during their biannual peri-implant maintenance recall appointment or contacted and asked to participate in a free clinical and radiographic examination to identify the possible presence of peri-implant pathology.
Key inclusion criteria (5 listed)
- patients within the age range of 18 to 80,
- non- or light smokers (<10cigarettes/day),
- no presence of infectious diseases at the time of implant placement or during the maintenance program,
- no presence of serious disease or condition known to alter bone metabolism,
- partial edentulous patients with stable periodontal condition with or without history of chronic periodontitis.
Key exclusion criteria (6 listed)
- pregnancy,
- history of heavy smoking,
- uncontrolled medical conditions such as diabetes mellitus,
- not adequate implant position (i.e., prosthetically driven),
- not properly restored impeding accurate probing depth recording
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 |
|---|---|---|
| Sensitivity testRoutine clinical and radiographic examination | Diagnostic test | Peri-implantitis, non-peri-implantitis patients |
Primary outcome
Sensitivity to detect peri-implantitis
Time frame: 1 year
Capability to diagnose disease
Specificity to detect peri-implantitis
Time frame: 1 year
Capability to diagnose health
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 11 May 2017.
- Individual participant dataSharing planned: No
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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.
Florencio Monje Gil study director
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
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 Sensitivity and Peri-implant Mucositis, run by Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain at 1 site in Spain.
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 5 inclusion and 6 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 11 May 2017. 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 Spain. 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?
Sensitivity to detect peri-implantitis (time frame: 1 year). The study lists 2 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 11 May 2017.