Early Apical Peri-implantitisEAPNCT03523845
Etiology of Early Apical Peri-implantitis
An observational study of Early Apical Peri-implantitis, run by University of Valencia.
Trial summary
A case-control study was performed was performed following the STROBE statement from 1996 to 2016 including patients who were diagnosed with early apical peri-implantitis. Data were collected at the time of implant placement, and once the patients developed signs and symptoms consistent with early apical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early Apical Peri-implantitis
- What is being tested?
- Observational intervention to diagnose an early apical peri-implantitis
- How many people
- 46 participants
- Where
- No sites listed yet
- Study dates
- Jan 1996to Dec 2016
- How long will I take part?
- 1 Year
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who received at least one dental implant
Who may be able to join
- The following inclusion criteria were applied: patients ≥18 years old and controlled medical conditions who received treatment with implants. Additionally, for the test group, inclusion criteria were: symptoms and signs suggesting early apical peri-implantitis after implant placement; absence of implant mobility; dull percussion of nonsurmerged implants; presence or absence of radiolucency apically.
Who cannot join
- for the both groups: implants placed with guided bone regeneration or inadequate follow-up for failing to maintenance visits.
About this study
Official title: Etiology of Early Apical Peri-implantitis: A Case-control Study Over a 20-year Period.
A case-control study was performed was performed following the STROBE statement from 1996 to 2016 including patients who were diagnosed with early apical peri-implantitis. Data were collected at the time of implant placement, and once the patients developed signs and symptoms consistent with early apical peri-implantitis, to determine the frequency and etiology of this pathology.
Read the detailed description
A case-control study was performed following the STROBE statement (17) at the Oral Surgery Department, Faculty of Medicine and Dentistry (University of Valencia, Spain) from 1996 to 2016, in which patients with early peri-implantitis diagnosed were included (Figure 1). All patients were informed about the study design and procedures. Prior to participating, they were requested to sign an informed consent document. The study design was approved by the Ethical Committee of the University of Valencia (H1478255958653).
Two groups were established: Test group (patients diagnosed with early apical peri-implantitis diagnosed) and Control group (patients whose implants had not developed any inflammatory/infectious process and were osseointegrated).
- Conditions
- Early Apical Peri-implantitis
- Being tested
- Observational intervention to diagnose an early apical peri-implantitis
- Keywords
- "early apical peri-implantitis"; "implant periapical lesion"; "retrograde peri-implantitis"; "implant failure"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational intervention to diagnose an early apical peri-implantitisOther
diagnose an early apical peri-implantitis
| Study group | Role | What they receive |
|---|---|---|
| Test group | Test group (patients diagnosed with early apical peri-implantitis diagnosed) Receives: Other: Observational intervention to diagnose an early apical peri-implantitis | |
| Control group | Control group (patients whose implants had not developed any inflammatory/infectious process and were osseointegrated) Receives: Other: Observational intervention to diagnose an early apical peri-implantitis |
What is being measured
The primary outcome is the main question the study is designed to answer.
type of surgery
immediate/delayed placement
Measured: Intraoperative
tooth-implant distance
mesial and distal tooth-implant distance measured at the apex
Measured: Intraoperative
Tooth status
apical lesion or endodontic treatment in the tooth being replaced or adjacent tooth endodontically treated
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study startJan 1996
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Early Apical Peri-implantitisStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Other
- Enrolment
- 46 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miguel Peñarrocha Diago, University of Valencia
- Investigators
- Miguel Peñarrocha Diago, MD, MDM, PhD, Study chair, Professor and Chairman of Oral Surgery and Implantology. Medical and Dental School, Universitat of València, SpainJuan Antonio Blaya Tárraga, DDS, MSc, Principal investigator, Master of Oral Surgery and Implantology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523845
- Sponsor's protocol ID
- LPI1
- Acronym
- EAP
- Status last verified
- May 2018
- First submitted
- 1 May 2018
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: higher permissions are needed to make the decision
Publications
Quirynen M, Gijbels F, Jacobs R. An infected jawbone site compromising successful osseointegration. Periodontol 2000. 2003;33:129-44. doi: 10.1046/j.0906-6713.2002.03311.x. No abstract available.
PubMed 12950847Lefever D, Van Assche N, Temmerman A, Teughels W, Quirynen M. Aetiology, microbiology and therapy of periapical lesions around oral implants: a retrospective analysis. J Clin Periodontol. 2013 Mar;40(3):296-302. doi: 10.1111/jcpe.12045. Epub 2012 Dec 27.
PubMed 23278599Penarrocha-Diago M, Maestre-Ferrin L, Cervera-Ballester J, Penarrocha-Oltra D. Implant periapical lesion: diagnosis and treatment. Med Oral Patol Oral Cir Bucal. 2012 Nov 1;17(6):e1023-7. doi: 10.4317/medoral.17996.
PubMed 22926472Zhao D, Wu Y, Xu C, Zhang F. Immediate dental implant placement into infected vs. non-infected sockets: a meta-analysis. Clin Oral Implants Res. 2016 Oct;27(10):1290-1296. doi: 10.1111/clr.12739. Epub 2015 Dec 15.
PubMed 26667097
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etiology of Early Apical Peri-implantitis: A Case-control Study Over a 20-year Period.
- ClinicalTrials.gov ID
- NCT03523845
- Acronym / sponsor ID
- EAP / LPI1
- Conditions
- Early Apical Peri-implantitis
- Keywords
- "early apical peri-implantitis"; "implant periapical lesion"; "retrograde peri-implantitis"; "implant failure"
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Jan 1996 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 14 May 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.
A case-control study was performed was performed following the STROBE statement from 1996 to 2016 including patients who were diagnosed with early apical peri-implantitis. Data were collected at the time of implant placement, and once the patients developed signs and symptoms consistent with early apical peri-implantitis, to determine the frequency and etiology of this pathology.
Detailed description
A case-control study was performed following the STROBE statement (17) at the Oral Surgery Department, Faculty of Medicine and Dentistry (University of Valencia, Spain) from 1996 to 2016, in which patients with early peri-implantitis diagnosed were included (Figure 1). All patients were informed about the study design and procedures. Prior to participating, they were requested to sign an informed consent document. The study design was approved by the Ethical Committee of the University of Valencia (H1478255958653).
Two groups were established: Test group (patients diagnosed with early apical peri-implantitis diagnosed) and Control group (patients whose implants had not developed any inflammatory/infectious process and were osseointegrated).
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | – | Other: Observational intervention to diagnose an early apical peri-implantitisTest group (patients diagnosed with early apical peri-implantitis diagnosed) |
| Control group | – | Other: Observational intervention to diagnose an early apical peri-implantitisControl group (patients whose implants had not developed any inflammatory/infectious process and were osseointegrated) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who received at least one dental implant
Key inclusion criteria (1 listed)
- The following inclusion criteria were applied: patients ≥18 years old and controlled medical conditions who received treatment with implants. Additionally, for the test group, inclusion criteria were: symptoms and signs suggesting early apical peri-implantitis after implant placement; absence of implant mobility; dull percussion of nonsurmerged implants; presence or absence of radiolucency apically.
Key exclusion criteria (1 listed)
- for the both groups: implants placed with guided bone regeneration or inadequate follow-up for failing to maintenance visits.
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 |
|---|---|---|
| Observational intervention to diagnose an early apical peri-implantitisdiagnose an early apical peri-implantitis | Other | Control group, Test group |
Primary outcome
type of surgery
Time frame: Intraoperative
immediate/delayed placement
tooth-implant distance
Time frame: Intraoperative
mesial and distal tooth-implant distance measured at the apex
Tooth status
Time frame: Intraoperative
apical lesion or endodontic treatment in the tooth being replaced or adjacent tooth endodontically treated
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 17 May 2018.
- Background: PubMed 12950847Quirynen M, Gijbels F, Jacobs R. An infected jawbone site compromising successful osseointegration. Periodontol 2000. 2003;33:129-44. doi: 10.1046/j.0906-6713.2002.03311.x. No abstract available.
- Results publication: PubMed 23278599Lefever D, Van Assche N, Temmerman A, Teughels W, Quirynen M. Aetiology, microbiology and therapy of periapical lesions around oral implants: a retrospective analysis. J Clin Periodontol. 2013 Mar;40(3):296-302. doi: 10.1111/jcpe.12045. Epub 2012 Dec 27.
- Results publication: PubMed 22926472Penarrocha-Diago M, Maestre-Ferrin L, Cervera-Ballester J, Penarrocha-Oltra D. Implant periapical lesion: diagnosis and treatment. Med Oral Patol Oral Cir Bucal. 2012 Nov 1;17(6):e1023-7. doi: 10.4317/medoral.17996.
- Results publication: PubMed 26667097Zhao D, Wu Y, Xu C, Zhang F. Immediate dental implant placement into infected vs. non-infected sockets: a meta-analysis. Clin Oral Implants Res. 2016 Oct;27(10):1290-1296. doi: 10.1111/clr.12739. Epub 2015 Dec 15.
- Individual participant dataSharing planned: Undecided. higher permissions are needed to make the decision
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.
Miguel Peñarrocha Diago, MD, MDM, PhD study chair
Professor and Chairman of Oral Surgery and Implantology. Medical and Dental School, Universitat of València, Spain
Juan Antonio Blaya Tárraga, DDS, MSc principal investigator
Master of Oral Surgery and Implantology
Questions about this trial
What is this clinical trial studying?
An observational study of Early Apical Peri-implantitis, run by University of Valencia.
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 1 inclusion and 1 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 17 May 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?
type of surgery (time frame: Intraoperative). 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?
On the ClinicalTrials.gov record for NCT03523845, which also lists 4 linked publications.
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 17 May 2018.