Peri-ImplantitisNCT05615051
Influence of Implant Surface Decontamination on the Reconstructive Outcomes of Peri-implantitis
A study testing Surface decontamination procedure aiming at reconstructive therapy in people with Peri-Implantitis, run by Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain at 1 site in Spain.
Trial summary
Two groups are aimed at being investigated in three centers (CICOM, Clinica Branemark and Clinica Joan Pi) Test group: Group electrolytic approach (EA): Mechanical detoxification using curettes + NiTi brushes + EA (GalvoSurge) during 2 minutes Control group: Group hydrogen peroxide (HP): Mechanical detoxification… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis
- What is being tested?
- Surface decontamination procedure aiming at reconstructive therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2022to 10 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Screw-retained or cement-retained fixed or removable implant-supported prosthesis for a minimum of 36 months.
- All patients in age of 18 to 80
- non-smokers
- no presence of systemic disease or medication known to alter bone metabolism
- partial or complete edentulous patients that have no active periodontal disease.
Who cannot join
- pregnancy or lactation
- history of or current smokers
- uncontrolled medical conditions,
- lacking keratinized mucosa (≤2mm) on the lingual or buccal implant sites,
- advanced(A) peri-implantitis (>50% of the implant length).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Implant Surface Decontamination on the Reconstructive Outcomes of Peri-implantitis: A Randomized Clinical Trial
Two groups are aimed at being investigated in three centers (CICOM, Clinica Branemark and Clinica Joan Pi)
- Test group: Group electrolytic approach (EA): Mechanical detoxification using curettes + NiTi brushes + EA (GalvoSurge) during 2 minutes
- Control group: Group hydrogen peroxide (HP): Mechanical detoxification using curettes + NiTi brushes + hydrogen peroxide 5% for 2 minutes soaked in a gauze Patients´ group selection will be randomly allocated. For patients whom their personal clinical record # ends in a number from 0 to 4 will be included in the test group, while for patients whom their personal clinical record # ends from 5-9 will be included in the control group.
The infra-osseous component will be regenerated using xenograft (Creos, NB) + autogenous bone in a ratio 1:1 harvested from the adjacent area. A resorbable membrane (Creos, NB) will be placed to compartmentalize the infra-osseous component following a poncho-like approach.
- Conditions
- Peri-Implantitis
- Being tested
- Surface decontamination procedure aiming at reconstructive therapy
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surface decontamination procedure aiming at reconstructive therapyDevice
Also called Hydrogen peroxide
Surface decontamination of infected implants followed by reconstructive therapy to manage peri-implantitis
| Study group | Role | What they receive |
|---|---|---|
| Group electrolytic approach (EA) | Experimental | Mechanical detoxification using curettes + NiTi brushes + EA (GalvoSurge) during 2 minutes Receives: Device: Surface decontamination procedure aiming at reconstructive therapy |
| Group hydrogen peroxide (HP) | Active comparator | Group hydrogen peroxide (HP): Mechanical detoxification using curettes + NiTi brushes + hydrogen peroxide 5% for 2 minutes soaked in a gauze Receives: Device: Surface decontamination procedure aiming at reconstructive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of the disease
No pocket depth >6mm, no bleeding on probing, no suppuration, no progressive bone loss
Measured: 12 months
Secondary outcomes (1)
Radiographic bone gain and clinical outcomes
Bone gain and changes in defect angle when compared to baseline radiographic features and evolution of clinical parameters compared to baseline data
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2022
- Study start1 Jan 2022
- Primary completion10 Dec 2024
- Study completion10 Jul 2026 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
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
- NCT05615051
- Sponsor's protocol ID
- 31102022
- Status last verified
- Jun 2025
- First submitted
- 7 Nov 2022
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Monje A, Navarro-Mesa S, Soldini C, Zappala G, Pena P, Navarro JM Sr, Pons R. Surface Decontamination on the Reconstructive Therapy of Peri-Implantitis: A Multicenter Randomized Clinical Trial. Clin Implant Dent Relat Res. 2025 Aug;27(4):e70075. doi: 10.1111/cid.70075.
PubMed 40693504
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Implant Surface Decontamination on the Reconstructive Outcomes of Peri-implantitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05615051
- Acronym / sponsor ID
- 31102022
- Conditions
- Peri-Implantitis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, SpainUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 10 Dec 2024 (actual)
- Study completion
- 10 Jul 2026 (estimated)
- First posted
- 14 Nov 2022 (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.
Two groups are aimed at being investigated in three centers (CICOM, Clinica Branemark and Clinica Joan Pi)
- Test group: Group electrolytic approach (EA): Mechanical detoxification using curettes + NiTi brushes + EA (GalvoSurge) during 2 minutes
- Control group: Group hydrogen peroxide (HP): Mechanical detoxification using curettes + NiTi brushes + hydrogen peroxide 5% for 2 minutes soaked in a gauze Patients´ group selection will be randomly allocated. For patients whom their personal clinical record # ends in a number from 0 to 4 will be included in the test group, while for patients whom their personal clinical record # ends from 5-9 will be included in the control group.
The infra-osseous component will be regenerated using xenograft (Creos, NB) + autogenous bone in a ratio 1:1 harvested from the adjacent area. A resorbable membrane (Creos, NB) will be placed to compartmentalize the infra-osseous component following a poncho-like approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Group electrolytic approach (EA) | Experimental | Device: Surface decontamination procedure aiming at reconstructive therapyMechanical detoxification using curettes + NiTi brushes + EA (GalvoSurge) during 2 minutes |
| Group hydrogen peroxide (HP) | Active comparator | Device: Surface decontamination procedure aiming at reconstructive therapyGroup hydrogen peroxide (HP): Mechanical detoxification using curettes + NiTi brushes + hydrogen peroxide 5% for 2 minutes soaked in a gauze |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Screw-retained or cement-retained fixed or removable implant-supported prosthesis for a minimum of 36 months.
- All patients in age of 18 to 80
- non-smokers
- no presence of systemic disease or medication known to alter bone metabolism
- partial or complete edentulous patients that have no active periodontal disease.
Key exclusion criteria (5 listed)
- pregnancy or lactation
- history of or current smokers
- uncontrolled medical conditions,
- lacking keratinized mucosa (≤2mm) on the lingual or buccal implant sites,
- advanced(A) peri-implantitis (>50% of the implant length).
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 |
|---|---|---|
| Surface decontamination procedure aiming at reconstructive therapyAlso: Hydrogen peroxideSurface decontamination of infected implants followed by reconstructive therapy to manage peri-implantitis | Device | Group electrolytic approach (EA), Group hydrogen peroxide (HP) |
Primary outcome
Resolution of the disease
Time frame: 12 months
No pocket depth >6mm, no bleeding on probing, no suppuration, no progressive bone loss
1 secondary outcome
Radiographic bone gain and clinical outcomes
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- Derived from this study: PubMed 40693504Monje A, Navarro-Mesa S, Soldini C, Zappala G, Pena P, Navarro JM Sr, Pons R. Surface Decontamination on the Reconstructive Therapy of Peri-Implantitis: A Multicenter Randomized Clinical Trial. Clin Implant Dent Relat Res. 2025 Aug;27(4):e70075. doi: 10.1111/cid.70075.
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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?
A study testing Surface decontamination procedure aiming at reconstructive therapy in people with 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 5 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Resolution of the disease (time frame: 12 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 NCT05615051, 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 8 Jun 2026.