Peri-ImplantitisNCT03777449
The Morphology of the Peri-Implantitis Defects: A Cone-Beam Computed Analysis
An observational study of Peri-Implantitis, run by Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain at 1 site in Spain.
Trial summary
To study the morphology of the peri-implant defects using cone-beam computed tomography based on a priori case definition of peri-implantitis (≥3mm of radiographic bone loss + inflammatory clinical parameters) Diagnosis of peri-implantitis requires: Presence of bleeding and/or suppuration on gentle probing. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- CBCT
- Type of treatment
- Surgery or procedure
- How many people
- 47 participants
- Where
- 1 siteSpain
- Study dates
- 10 Aug 2018to 1 May 2019
- How long will I take part?
- 6 Months
- 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 Any age
- Child, Adult, Older adult
Study population: Healthy partially/complete edentulous having previously received screw-retained implants for oral rehabilitation for ≥3 years.
Who may be able to join
- Male or female patients between 18 and 80 years of age
- Partial/complete edentulism missing one or more teeth and having it restored with implant-supported prosthesis
- No antibiotic in the last 2 months previous to examination
- >3 year after prosthesis delivery
Who cannot join
- Uncontrolled systemic disease
- Cemented-retained restorations
- Patients with uncontrolled/active periodontal disease in need of periodontal treatment
- Pregnant patients
- Zygomatic implants
- Implants placed in regenerated/augmented bone
- Patients taking medications known to modify bone metabolism or known to have degenerative diseases of bone (hyperparathyroidism, osteoporosis), vitamin D, patients who had taken antibiotics, NSAIDS or corticosteroids for more than two weeks in the past 3 months before examination
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Morphology of the Peri-Implantitis Defects: A Cone-Beam Computed
To study the morphology of the peri-implant defects using cone-beam computed tomography based on a priori case definition of peri-implantitis (≥3mm of radiographic bone loss + inflammatory clinical parameters)
Diagnosis of peri-implantitis requires:
Read more
- Presence of bleeding and/or suppuration on gentle probing.
- Increased probing depth compared to previous examinations.
- Presence of bone loss beyond crestal bone level changes resulting from initial bone remodeling.
In the absence of previous examination data diagnosis of peri-implantitis can be based on the combination of:
- Presence of bleeding and/or suppuration on gentle probing.
- Probing depths of ≥6 mm.
- Bone levels ≥3 mm apical of the most coronal portion of the intraosseous part of the implant.
Read the detailed description
Nowadays, several radiographic techniques are available to investigate the peri-implant bone morphology by two-dimensional radiographs such as panoramic radiography and intraoral radiography, or three-dimensional techniques such as computer tomography and cone beam computer tomography (CBCT) (Harris et al. 2012). CBCT provides high-contrast 3D visualization of bone beds; however, artifacts caused by the metallic character of implants could disguise information around implants. The diagnostic outcomes of CBCT imaging of peri-implant bone loss have been related to the type of study and defect morphology (Pelekos et al., 2018). The ex vivo studies (cadaver models), considering sensitivity and specificity reported good values for both circumferential and infrabony defects but lower for dehiscences (de-Azevedo-Vaz et al., 2013, Kamburoglu et al., 2013). Contrastingly, CBCT imaging for defect analysis in animal studies showed positive correlation with histology but tend to overestimate (Fienitz et al., 2012, Golubovic et al., 2012) or underestimate (Corpas Ldos et al., 2011, Ritter et al., 2014) the size of the defect. This variability in the measurement is mainly dependent on the different configuration, location or size of the defect. and also by the scattering, beam hardening artifacts, energy settings, exposure time, field of view.
Hence, it is aimed at assessing the morphology of the peri-implant defects using CBCT
- Conditions
- Peri-Implantitis
- Being tested
- CBCT
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCTRadiation
Patients will be taken a CBCT as a diagnostic tool to monitor peri-implant bone loss. This is a tool used on the daily basis for the evaluation of peri-implant bone loss. Patient will not be exposed to further radiation but the regular one.
| Study group | Role | What they receive |
|---|---|---|
| Vertical bone loss | Infra-osseous defects Receives: Radiation: CBCT | |
| Horizontal bone loss | Supra-osseous defects Receives: Radiation: CBCT | |
| Combined bone loss | Combined supra-osseous and infra-osseous defects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphology
Morphology of the peri-implant defects ivy number of existing bone walls present (1, 2, 3 or 4)
Measured: 6 months
Secondary outcomes (1)
Severity of the peri-implant bone loss
Distance in mm from the top of the implant down to the defect base
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start10 Aug 2018
- Primary completion1 May 2019
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777449
- Sponsor's protocol ID
- 18002909-12/2018
- Status last verified
- Apr 2020
- First submitted
- 14 Dec 2018
- Last updated
- 28 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Monje A, Pons R, Insua A, Nart J, Wang HL, Schwarz F. Morphology and severity of peri-implantitis bone defects. Clin Implant Dent Relat Res. 2019 Aug;21(4):635-643. doi: 10.1111/cid.12791. Epub 2019 May 14.
PubMed 31087457
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Morphology of the Peri-Implantitis Defects: A Cone-Beam Computed
- ClinicalTrials.gov ID
- NCT03777449
- Acronym / sponsor ID
- 18002909-12/2018
- Conditions
- Peri-Implantitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, SpainUniversity, hospital or other
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 17 Dec 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.
To study the morphology of the peri-implant defects using cone-beam computed tomography based on a priori case definition of peri-implantitis (≥3mm of radiographic bone loss + inflammatory clinical parameters)
Diagnosis of peri-implantitis requires:
- Presence of bleeding and/or suppuration on gentle probing.
- Increased probing depth compared to previous examinations.
- Presence of bone loss beyond crestal bone level changes resulting from initial bone remodeling.
In the absence of previous examination data diagnosis of peri-implantitis can be based on the combination of:
- Presence of bleeding and/or suppuration on gentle probing.
- Probing depths of ≥6 mm.
- Bone levels ≥3 mm apical of the most coronal portion of the intraosseous part of the implant.
Detailed description
Nowadays, several radiographic techniques are available to investigate the peri-implant bone morphology by two-dimensional radiographs such as panoramic radiography and intraoral radiography, or three-dimensional techniques such as computer tomography and cone beam computer tomography (CBCT) (Harris et al. 2012). CBCT provides high-contrast 3D visualization of bone beds; however, artifacts caused by the metallic character of implants could disguise information around implants. The diagnostic outcomes of CBCT imaging of peri-implant bone loss have been related to the type of study and defect morphology (Pelekos et al., 2018). The ex vivo studies (cadaver models), considering sensitivity and specificity reported good values for both circumferential and infrabony defects but lower for dehiscences (de-Azevedo-Vaz et al., 2013, Kamburoglu et al., 2013). Contrastingly, CBCT imaging for defect analysis in animal studies showed positive correlation with histology but tend to overestimate (Fienitz et al., 2012, Golubovic et al., 2012) or underestimate (Corpas Ldos et al., 2011, Ritter et al., 2014) the size of the defect. This variability in the measurement is mainly dependent on the different configuration, location or size of the defect. and also by the scattering, beam hardening artifacts, energy settings, exposure time, field of view.
Hence, it is aimed at assessing the morphology of the peri-implant defects using CBCT
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vertical bone loss | – | Radiation: CBCTInfra-osseous defects |
| Horizontal bone loss | – | Radiation: CBCTSupra-osseous defects |
| Combined bone loss | – | –Combined supra-osseous and infra-osseous defects |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy partially/complete edentulous having previously received screw-retained implants for oral rehabilitation for ≥3 years.
Key inclusion criteria (4 listed)
- Male or female patients between 18 and 80 years of age
- Partial/complete edentulism missing one or more teeth and having it restored with implant-supported prosthesis
- No antibiotic in the last 2 months previous to examination
- >3 year after prosthesis delivery
Key exclusion criteria (7 listed)
- Uncontrolled systemic disease
- Cemented-retained restorations
- Patients with uncontrolled/active periodontal disease in need of periodontal treatment
- Pregnant patients
- Zygomatic implants
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 |
|---|---|---|
| CBCTPatients will be taken a CBCT as a diagnostic tool to monitor peri-implant bone loss. This is a tool used on the daily basis for the evaluation of peri-implant bone loss. Patient will not be exposed to further radiation but the regular one. | Radiation | Horizontal bone loss, Vertical bone loss |
Primary outcome
Morphology
Time frame: 6 months
Morphology of the peri-implant defects ivy number of existing bone walls present (1, 2, 3 or 4)
1 secondary outcome
Severity of the peri-implant bone loss
Time frame: 6 months
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 28 Apr 2020.
- Derived from this study: PubMed 31087457Monje A, Pons R, Insua A, Nart J, Wang HL, Schwarz F. Morphology and severity of peri-implantitis bone defects. Clin Implant Dent Relat Res. 2019 Aug;21(4):635-643. doi: 10.1111/cid.12791. Epub 2019 May 14.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 4 inclusion and 7 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 28 Apr 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 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?
Morphology (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03777449, which also lists 1 linked publication.
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 28 Apr 2020.