Peri-ImplantitisNCT03620331
Surgical Treatment of Peri-implantitis With and Without an Initial Non-surgical Approach
A study testing Surgery with a previous non-surgical approach and Surgery without a previous non-surgical approach in people with Peri-Implantitis, run by Universidad Complutense de Madrid at 3 sites in 2 countries.
Trial summary
Randomized, surgeon and outcome assessor blinded, multi-centric, superiority trial with two parallel groups and a 1:1 allocation ratio with the aim of comparing the surgical treatment of severe peri-implantitis with or without an initial non surgical approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Surgery with a previous non-surgical approach and Surgery without a previous non-surgical approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Jul 2018to 30 Nov 2020
- Phase
- Interventional
- 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
Who may be able to join
- Any patient having at least one implant affected by severe peri-implantitis, being at least 18 years old and able to sign an informed consent form will be potentially eligible for this trial.
- Severe peri-implantitis will be defined as peri-implant probing pocket depth [PPD] ≥6 mm in at least 1 site of the implant, together with bleeding and/or suppuration on probing [BoP and/or SoP, respectively] and radiographically documented marginal bone loss/level ≥3 mm (Carcuac et al. 2016) on implants in function by at least 1 year. In case of absence of baseline radiographs, the reference point for baseline bone levels will be considered where bone was likely to be at implant placement.
Who cannot join
- Patients fitting to all the inclusion criteria as above will be not included in the study if they appear to be unable to attend to the study-related procedures (including the follow-up visits) or if one or more of the following systemic or local exclusion criteria are found in the enrolment phase.
- Systemic primary exclusion criteria:
- compromised general health which contraindicates the study procedures (ASA IV-VI patients);
- systemic diseases which could influence the outcome of the therapy (uncontrolled diabetes mellitus);
- pregnant or nursing women;
- chronic use of corticosteroids or NSAID or immune-modulator drugs (any type and any dose);
Show all 12Show fewer
- patients who need use of medications affecting bone metabolism or peri-implant mucosa (bisphosphonates, any type and any dose).
- Local primary exclusion criteria:
- history of peri-implantitis treatment on implants to be included in the study (included topical antibiotics);
- hopeless implants (e.g. mobility) to be included in the study.
- Secondary exclusion criteria:
- uncompliant patients (poor oral hygiene 2 weeks after OHI).
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Italy2 sites
Policlinico Umberto I - "G. Eastman" Section - Department of Periodontology
Roma
Department of Surgical Sciences, C.I.R. Dental School, University of Turin
Turin
Spain1 site
Department of Periodontology, University Complutense Madrid, Spain
Madrid
About this study
Official title: Surgical Treatment of Peri-implantitis With and Without an Initial Non-surgical Approach: a Multi-center Randomized Clinical Trial
Randomized, surgeon and outcome assessor blinded, multi-centric, superiority trial with two parallel groups and a 1:1 allocation ratio with the aim of comparing the surgical treatment of severe peri-implantitis with or without an initial non surgical approach.
- Conditions
- Peri-Implantitis
- Being tested
- Surgery with a previous non-surgical approach, Surgery without a previous non-surgical approach
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery with a previous non-surgical approachProcedure or surgery
Non-surgical phase done prior to the surgical treatment of peri-implantitis
Surgery without a previous non-surgical approachProcedure or surgery
Non-surgical phase not done prior to the surgical treatment of peri-implantitis
| Study group | Role | What they receive |
|---|---|---|
| Non Surgical + Surgical | Active comparator | Non surgical approach (NS) followed by surgical treatment (S) of peri-implantitis Receives: Procedure: Surgery with a previous non-surgical approach |
| Immediate Surgery | Experimental | Direct surgical approach (S), without a previous non surgical approach Receives: Procedure: Surgery without a previous non-surgical approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Resolution
Measured: 1 year post-surgery
Probing Pocket Depth changes
Measured from the mucosal margin to the bottom of the probeable pocket.
Measured: 1 year post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start1 Jul 2018
- Primary completion30 Nov 2020
- Study completion30 Nov 2020
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.
- More trials run by Universidad Complutense de MadridThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Policlinico Umberto I, University of Turin, Italy, Osteology Foundation
- Responsible party
- Sponsor
- Investigators
- Mariano Sanz Alonso, Study chair, Department of Periodontology, University Complutense Madrid, SpainLuca Cordaro, Study chair, Department of Periodontology and Prosthodontics, "Umberto I" Policlinic - "G. Eastman" SectionMario Romandini, Study director, Department of Periodontology, University Complutense Madrid, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620331
- Sponsor's protocol ID
- Peri-implantitis_ImmediateSurg
- Status last verified
- May 2021
- First submitted
- 2 Aug 2018
- Last updated
- 14 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Romandini M, Lafori A, Pedrinaci I, Baima G, Ferrarotti F, Lima C, Paterno Holtzman L, Aimetti M, Cordaro L, Sanz M. Effect of sub-marginal instrumentation before surgical treatment of peri-implantitis: A multi-centre randomized clinical trial. J Clin Periodontol. 2022 Dec;49(12):1334-1345. doi: 10.1111/jcpe.13713. Epub 2022 Sep 9.
PubMed 36085409
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Treatment of Peri-implantitis With and Without an Initial Non-surgical Approach: a Multi-center Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03620331
- Acronym / sponsor ID
- Peri-implantitis_ImmediateSurg
- Conditions
- Peri-Implantitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Azienda Policlinico Umberto I, University of Turin, Italy, Osteology Foundation
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 8 Aug 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.
Randomized, surgeon and outcome assessor blinded, multi-centric, superiority trial with two parallel groups and a 1:1 allocation ratio with the aim of comparing the surgical treatment of severe peri-implantitis with or without an initial non surgical approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non Surgical + Surgical | Active comparator | Procedure: Surgery with a previous non-surgical approachNon surgical approach (NS) followed by surgical treatment (S) of peri-implantitis |
| Immediate Surgery | Experimental | Procedure: Surgery without a previous non-surgical approachDirect surgical approach (S), without a previous non surgical approach |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any patient having at least one implant affected by severe peri-implantitis, being at least 18 years old and able to sign an informed consent form will be potentially eligible for this trial.
- Severe peri-implantitis will be defined as peri-implant probing pocket depth [PPD] ≥6 mm in at least 1 site of the implant, together with bleeding and/or suppuration on probing [BoP and/or SoP, respectively] and radiographically documented marginal bone loss/level ≥3 mm (Carcuac et al. 2016) on implants in function by at least 1 year. In case of absence of baseline radiographs, the reference point for baseline bone levels will be considered where bone was likely to be at implant placement.
Key exclusion criteria (12 listed)
- Patients fitting to all the inclusion criteria as above will be not included in the study if they appear to be unable to attend to the study-related procedures (including the follow-up visits) or if one or more of the following systemic or local exclusion criteria are found in the enrolment phase.
- compromised general health which contraindicates the study procedures (ASA IV-VI patients);
- systemic diseases which could influence the outcome of the therapy (uncontrolled diabetes mellitus);
- pregnant or nursing women;
- chronic use of corticosteroids or NSAID or immune-modulator drugs (any type and any dose);
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 |
|---|---|---|
| Surgery with a previous non-surgical approachNon-surgical phase done prior to the surgical treatment of peri-implantitis | Procedure or surgery | Non Surgical + Surgical |
| Surgery without a previous non-surgical approachNon-surgical phase not done prior to the surgical treatment of peri-implantitis | Procedure or surgery | Immediate Surgery |
Primary outcome
Disease Resolution
Time frame: 1 year post-surgery
Probing Pocket Depth changes
Time frame: 1 year post-surgery
Measured from the mucosal margin to the bottom of the probeable pocket.
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 14 May 2021.
- Derived from this study: PubMed 36085409Romandini M, Lafori A, Pedrinaci I, Baima G, Ferrarotti F, Lima C, Paterno Holtzman L, Aimetti M, Cordaro L, Sanz M. Effect of sub-marginal instrumentation before surgical treatment of peri-implantitis: A multi-centre randomized clinical trial. J Clin Periodontol. 2022 Dec;49(12):1334-1345. doi: 10.1111/jcpe.13713. Epub 2022 Sep 9.
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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.
Mariano Sanz Alonso study chair
Department of Periodontology, University Complutense Madrid, Spain
Luca Cordaro study chair
Department of Periodontology and Prosthodontics, "Umberto I" Policlinic - "G. Eastman" Section
Mario Romandini study director
Department of Periodontology, University Complutense Madrid, Spain
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery with a previous non-surgical approach and Surgery without a previous non-surgical approach in people with Peri-Implantitis, run by Universidad Complutense de Madrid at 3 sites in 2 countries.
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 2 inclusion and 12 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 14 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy, 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?
Disease Resolution (time frame: 1 year post-surgery). 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?
On the ClinicalTrials.gov record for NCT03620331, 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 14 May 2021.