PeriimplantitisNCT05811390
Non-surgical Treatment of Periimplantitis - Conventional Hand Instrumentation Versus Air-polishing
A study testing erythritol jet and Manual instrumentation in people with Periimplantitis, run by Universidade do Porto at 1 site in Portugal.
Trial summary
The purpose of this study is to evaluate the clinical efficacy of ultrasonic instrumentation versus the use of an erythritol jet in the treatment of peri-implantitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periimplantitis
- What is being tested?
- erythritol jet and Manual instrumentation
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Oct 2022to 30 Jul 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 1 osseointegrated implant diagnosed with peri-implantitis (according to the new Classification of Periodontal and Peri-implant Diseases and Conditions) and rehabilitated with screw-retained crown
- Patients of legal age (≥18 years old)
Who cannot join
- Uncontrolled systemic pathologies, namely diabetes mellitus (HbA1c > 7% or >53 mmol/mol)
- Pregnant or lactating patients
- Severe smoking (>20 cigarettes/day)
- Systemic pathologies, medication or treatments that cause alterations in bone metabolism (for example: osteoporosis, bisphosphonates, radiotherapy of the head and neck)
- Patients who missed study control visits
- Patients who have received systemic antibiotic therapy in the last 2 months
Show all 9Show fewer
- Patients with allergies to any of the components used in the study, namely to erythritol
- Implants that have previously undergone surgical treatment for peri-implantitis
- Implants with bone loss greater than 2/3 of their length and/or mobility
Trial locations and contacts
1 site in 1 country.
Portugal1 site
Faculty of Dentistry at the University of OPorto
Porto, Porto District, 4200-393
About this study
Official title: Non-surgical Treatment of Periimplantitis - Conventional Hand Instrumentation Versus Air-polishing and Systemic Metronidazole With a 12 Months Follow-up, a Parallel Randomized Controlled Clinical Trial
The purpose of this study is to evaluate the clinical efficacy of ultrasonic instrumentation versus the use of an erythritol jet in the treatment of peri-implantitis.
Read the detailed description
To carry out this study, the investigators considered a treatment protocol for periimplantitis consisting of 2 phases. The first phase corresponds to the non-surgical treatment of periimplantitis, which can be performed using various techniques. In the present study, it will be carried out using manual instrumentation (with ultrasound and curettes) or with an erythritol jet. In both cases, systemic antibiotic therapy with metronidazole will be performed. The results obtained during the follow-ups will allow the evaluation of the effectiveness of the treatment carried out. If this does not prove to be successful, through an evaluation of clinical and radiographic criteria, patients will be advised to undergo a second phase of treatment, in this case a surgical treatment of peri-implantitis, but which will no longer be part of the interventions carried out and documented in this study. Patients for whom the unsatisfactory treatment was considered effective will be allocated to a periimplant support treatment program, which means that they will be advised to carry out maintenance consultations at the FMDUP clinic with a specific and individualized periodicity in order to maintain the health of the periimplant tissues and the remaining oral cavity. The study will be carried out by the students of the Specialization in Periodontology and Oral Implantology 2021-2024 of the Faculty of Dental Medicine of the University of Porto (FMDUP).
- Conditions
- Periimplantitis
- Being tested
- erythritol jet, Manual instrumentation
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erythritol jetDevice
Use of an erythritol jet in the non-surgical treatment of periimplantitis together with systemic metronidazole
Manual instrumentationDevice
Use of manual instrumentation in the non-surgical treatment of periimplantitis together with systemic metronidazole
| Study group | Role | What they receive |
|---|---|---|
| erythritol jet (EMS) | Experimental | An erythritol jet (Perioflow from EMS) will be used to debride the periodontal pockets of oral implants diagnosed with per-implantitis. Receives: Device: erythritol jet |
| Manual instrumentation | Active comparator | An ultrasonic handpiece will be used to debride the periodontal pockets of oral implants diagnosed with per-implantitis. Receives: Device: Manual instrumentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in probing pocket depth
The distance measured from the base of the sulcus or pocket to the free gingival margin at six points per implant (measured in millimetres).
Measured: 0, 3, 6, 12 months
Secondary outcomes (5)
PROMS
Patient reported outcomes reported on a visual analog scale from 0 (no pain) to 10 (maximum pain).
Measured: 0 months
Change in alveolar bone level
Radiographically measured alveolar bone level from the alveolar crest to the implant's neck, mesially and distally (measured in millimetres).
Measured: 0,12 months
Change in gingival recession
Gingival recession measured at six points per implant with a periodontal probe, from the cementum-enamel junction to the bottom of the probable pocket (measured in millimetres).
Measured: 0, 3, 6, 12 months
Bleeding on probing
Bleeding on probing (in percentage) assessed 30 seconds after probing, through a dichotomous scoring system used at six sites per implant using one (1) and zero (0) for presence or absence, respectively.
Measured: 0, 3, 6, 12 months
Implant survival rate
Percentage of implants that survived after 1 year follow-up (implants that remain in the patient's mouth after 1 year).
Measured: 0, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start1 Oct 2022
- Primary completion30 Jun 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriimplantitisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- EMS
- Responsible party
- Sponsor
- Investigators
- Ana Isabel Moreira, Principal investigator, Faculdade de Medicina Dentária da Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811390
- Sponsor's protocol ID
- Periimplantitis treatment
- Status last verified
- Feb 2025
- First submitted
- 23 Feb 2023
- Last updated
- 6 Apr 2025
- 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 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-surgical Treatment of Periimplantitis - Conventional Hand Instrumentation Versus Air-polishing and Systemic Metronidazole With a 12 Months Follow-up, a Parallel Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05811390
- Acronym / sponsor ID
- Periimplantitis treatment
- Conditions
- Periimplantitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- EMS
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 13 Apr 2023 (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 this study is to evaluate the clinical efficacy of ultrasonic instrumentation versus the use of an erythritol jet in the treatment of peri-implantitis.
Detailed description
To carry out this study, the investigators considered a treatment protocol for periimplantitis consisting of 2 phases. The first phase corresponds to the non-surgical treatment of periimplantitis, which can be performed using various techniques. In the present study, it will be carried out using manual instrumentation (with ultrasound and curettes) or with an erythritol jet. In both cases, systemic antibiotic therapy with metronidazole will be performed. The results obtained during the follow-ups will allow the evaluation of the effectiveness of the treatment carried out. If this does not prove to be successful, through an evaluation of clinical and radiographic criteria, patients will be advised to undergo a second phase of treatment, in this case a surgical treatment of peri-implantitis, but which will no longer be part of the interventions carried out and documented in this study. Patients for whom the unsatisfactory treatment was considered effective will be allocated to a periimplant support treatment program, which means that they will be advised to carry out maintenance consultations at the FMDUP clinic with a specific and individualized periodicity in order to maintain the health of the periimplant tissues and the remaining oral cavity. The study will be carried out by the students of the Specialization in Periodontology and Oral Implantology 2021-2024 of the Faculty of Dental Medicine of the University of Porto (FMDUP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| erythritol jet (EMS) | Experimental | Device: erythritol jetAn erythritol jet (Perioflow from EMS) will be used to debride the periodontal pockets of oral implants diagnosed with per-implantitis. |
| Manual instrumentation | Active comparator | Device: Manual instrumentationAn ultrasonic handpiece will be used to debride the periodontal pockets of oral implants diagnosed with per-implantitis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least 1 osseointegrated implant diagnosed with peri-implantitis (according to the new Classification of Periodontal and Peri-implant Diseases and Conditions) and rehabilitated with screw-retained crown
- Patients of legal age (≥18 years old)
Key exclusion criteria (9 listed)
- Uncontrolled systemic pathologies, namely diabetes mellitus (HbA1c > 7% or >53 mmol/mol)
- Pregnant or lactating patients
- Severe smoking (>20 cigarettes/day)
- Systemic pathologies, medication or treatments that cause alterations in bone metabolism (for example: osteoporosis, bisphosphonates, radiotherapy of the head and neck)
- Patients who missed study control 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 |
|---|---|---|
| erythritol jetUse of an erythritol jet in the non-surgical treatment of periimplantitis together with systemic metronidazole | Device | erythritol jet (EMS) |
| Manual instrumentationUse of manual instrumentation in the non-surgical treatment of periimplantitis together with systemic metronidazole | Device | Manual instrumentation |
Primary outcome
Change in probing pocket depth
Time frame: 0, 3, 6, 12 months
The distance measured from the base of the sulcus or pocket to the free gingival margin at six points per implant (measured in millimetres).
5 secondary outcomes
PROMS
Time frame: 0 months
Change in alveolar bone level
Time frame: 0,12 months
Change in gingival recession
Time frame: 0, 3, 6, 12 months
Bleeding on probing
Time frame: 0, 3, 6, 12 months
Implant survival rate
Time frame: 0, 12 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 6 Apr 2025.
- 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.
Ana Isabel Moreira principal investigator
Faculdade de Medicina Dentária da Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing erythritol jet and Manual instrumentation in people with Periimplantitis, run by Universidade do Porto at 1 site in Portugal.
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 9 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 6 Apr 2025. 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 Portugal. 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?
Change in probing pocket depth (time frame: 0, 3, 6, 12 months). 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 6 Apr 2025.