Peri-ImplantitisNCT05179746
Adjunctive Benefit of Electrolytic Cleaning on Non-surgical Treatment of Peri-implantitis.
A study testing Implants are decontaminated with electrolytic cleaning and Implants are decontaminated without electrolytic cleaning in people with Peri-Implantitis, run by University of Lisbon.
Trial summary
Evaluate the outcomes of non-surgical therapy of peri-implantitis with the adjunctive use of electrolytic cleaning (Galvo Surge®). The proposed protocol, focused on the non-surgical treatment of peri-implantitis, will result in a higher percentage of subjects with disease resolution (probing depts ≤ 5mm, absence of… 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?
- Implants are decontaminated with electrolytic cleaning and Implants are decontaminated without electrolytic cleaning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2022to 1 Sep 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Partially edentulous patients, rehabilitated with at least one dental implant in the maxilla or mandible;
- Presence of Peri-implantitis;
- No implant mobility;
- Treated periodontal disease;
- No systemic diseases that could influence the outcome of the therapy (i.e. uncontrolled diabetes, osteoporosis, bisphosphonate medication).
- Non-smoker or light smoking status in smokers (<10 cigarettes/day).
Who cannot join
- Pregnant, lactating women and non-collaborating patients will be excluded from the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Adjunctive Benefit of Electrolytic Cleaning on Non-surgical Treatment of Peri-implantitis. A 1-year Randomized Controlled Clinical Trial.
Evaluate the outcomes of non-surgical therapy of peri-implantitis with the adjunctive use of electrolytic cleaning (Galvo Surge®).
The proposed protocol, focused on the non-surgical treatment of peri-implantitis, will result in a higher percentage of subjects with disease resolution (probing depts ≤ 5mm, absence of BOP and/or SOP and no further bone loss) at 1 year of follow-up.
Read the detailed description
The adjunctive use of electrolytic cleaning (Galvo Surge®) in the non-surgical treatment of peri-implantitis will result in a higher reduction of probing depth than the control group.
The adjunctive use of electrolytic cleaning (Galvo Surge®) in the non-surgical treatment of peri-implantitis will result in a higher radiographic bone fill of the peri-implant defect than the control group.
The adjunctive use of electrolytic cleaning (Galvo Surge®) in the non-surgical treatment of peri-implantitis will result in a lower count of peri-implant pathogens than the control group.
- Conditions
- Peri-Implantitis
- Being tested
- Implants are decontaminated with electrolytic cleaning, Implants are decontaminated without electrolytic cleaning
- Keywords
- treatment of peri-implantitis, electrolytic cleaning
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implants are decontaminated with electrolytic cleaningDevice
Implants are decontaminated with electrolytic cleaning
Implants are decontaminated without electrolytic cleaningDevice
Implants are decontaminated without electrolytic cleaning
| Study group | Role | What they receive |
|---|---|---|
| With electrolytic cleaning | Active comparator | Mechanical debridement with ultrasonics (plastic tip) and plastic curettes Receives: Device: Implants are decontaminated with electrolytic cleaning |
| Without electrolytic cleaning | Placebo comparator | Mechanical debridement with ultrasonics (plastic tip) and plastic curettes Receives: Device: Implants are decontaminated without electrolytic cleaning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Probing pocket depth
Will be calculated as the distance from the gingival peri-implant margin to the bottom of the peri-implant pocket (Mombelli \& Lang, 1994).
Measured: Assessing the change of probing pocket depth from baseline at 3 months, 6 months and 12 months
Recession
will be measured as the distance from the free marginal mucosa to the most apical portion of the crown.
Measured: Assessing the change of recession from baseline at 3 months, 6 months and 12 months
Clinical attachment level
will be calculated as the sum of PPD and REC (distance from the most apical portion of the crown to the bottom of the periodontal pocket)
Measured: Assessing the change from clinical attachment level from baseline at 3 months, 6 months and 12 months
Bleeding on probing
will be assessed dichotomously in six sites per implant (Heitz-Mayfield, 2008).
Measured: Assessing the change from bleeding on probing from baseline at 3 months, 6 months and 12 months
Radiographic Parameters
Radiographic analysis through orthopantomography, periapical intraoral radiographs according to the parallelometric technique (using a silicone bite record so that the radiographs are parallelized and comparable to each other in different timepoints, checking in millimeters the increase or decrease in bone loss).
Measured: Assessing the change of the radiographic parameters from baseline at 3 months, 6 months
Secondary outcomes (1)
Microbiological Parameters
A sterilized paper tip from the microbiological kit will be introduced in the periimplantitis pocket, remaining in the same position for 10 seconds. After collecting the sample, the paper tip will be placed in an individual transfer tube, properly identified. Afterwards, the sample will be sent to the laboratory, where a polymerase chain reaction (PCR) test is performed to identify the following bacteria - A. actinomycetemcomitans, T. forsythia, T. denticola, P. gingivalis, P. intermedia and F. nucleatum.
Measured: Assessing the change of the microbiological parameters from baseline at 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start1 Oct 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Lisbon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanessa Rocha Rodrigues, University of Lisbon
- Investigators
- Tiago Ribeiro-Amaral, Dr, Principal investigator, University of LisbonPaulo Macaranhas, PhD, Study director, University of LisbonVanessa Rocha Rodrigues, Dr, Study chair, University of LisbonSusana Noronha, PhD, Study director, University of Lisbon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179746
- Sponsor's protocol ID
- Electrolytic cleaning
- Status last verified
- Jun 2022
- First submitted
- 3 Dec 2021
- Last updated
- 24 Jun 2022
- 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 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Benefit of Electrolytic Cleaning on Non-surgical Treatment of Peri-implantitis. A 1-year Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT05179746
- Acronym / sponsor ID
- Electrolytic cleaning
- Conditions
- Peri-Implantitis
- Keywords
- treatment of peri-implantitis, electrolytic cleaning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of LisbonUniversity, hospital or other
- Study start
- 1 Oct 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 5 Jan 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.
Evaluate the outcomes of non-surgical therapy of peri-implantitis with the adjunctive use of electrolytic cleaning (Galvo Surge®).
The proposed protocol, focused on the non-surgical treatment of peri-implantitis, will result in a higher percentage of subjects with disease resolution (probing depts ≤ 5mm, absence of BOP and/or SOP and no further bone loss) at 1 year of follow-up.
Detailed description
The adjunctive use of electrolytic cleaning (Galvo Surge®) in the non-surgical treatment of peri-implantitis will result in a higher reduction of probing depth than the control group.
The adjunctive use of electrolytic cleaning (Galvo Surge®) in the non-surgical treatment of peri-implantitis will result in a higher radiographic bone fill of the peri-implant defect than the control group.
The adjunctive use of electrolytic cleaning (Galvo Surge®) in the non-surgical treatment of peri-implantitis will result in a lower count of peri-implant pathogens than the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| With electrolytic cleaning | Active comparator | Device: Implants are decontaminated with electrolytic cleaningMechanical debridement with ultrasonics (plastic tip) and plastic curettes |
| Without electrolytic cleaning | Placebo comparator | Device: Implants are decontaminated without electrolytic cleaningMechanical debridement with ultrasonics (plastic tip) and plastic curettes |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Partially edentulous patients, rehabilitated with at least one dental implant in the maxilla or mandible;
- Presence of Peri-implantitis;
- No implant mobility;
- Treated periodontal disease;
- No systemic diseases that could influence the outcome of the therapy (i.e. uncontrolled diabetes, osteoporosis, bisphosphonate medication).
Key exclusion criteria (1 listed)
- Pregnant, lactating women and non-collaborating patients will be excluded from the study.
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 |
|---|---|---|
| Implants are decontaminated with electrolytic cleaningImplants are decontaminated with electrolytic cleaning | Device | With electrolytic cleaning |
| Implants are decontaminated without electrolytic cleaningImplants are decontaminated without electrolytic cleaning | Device | Without electrolytic cleaning |
Primary outcome
Probing pocket depth
Time frame: Assessing the change of probing pocket depth from baseline at 3 months, 6 months and 12 months
Will be calculated as the distance from the gingival peri-implant margin to the bottom of the peri-implant pocket (Mombelli \& Lang, 1994).
Recession
Time frame: Assessing the change of recession from baseline at 3 months, 6 months and 12 months
will be measured as the distance from the free marginal mucosa to the most apical portion of the crown.
Clinical attachment level
Time frame: Assessing the change from clinical attachment level from baseline at 3 months, 6 months and 12 months
will be calculated as the sum of PPD and REC (distance from the most apical portion of the crown to the bottom of the periodontal pocket)
Bleeding on probing
Time frame: Assessing the change from bleeding on probing from baseline at 3 months, 6 months and 12 months
will be assessed dichotomously in six sites per implant (Heitz-Mayfield, 2008).
Radiographic Parameters
Time frame: Assessing the change of the radiographic parameters from baseline at 3 months, 6 months
Radiographic analysis through orthopantomography, periapical intraoral radiographs according to the parallelometric technique (using a silicone bite record so that the radiographs are parallelized and comparable to each other in different timepoints, checking in millimeters the increase or decrease in bone loss).
1 secondary outcome
Microbiological Parameters
Time frame: Assessing the change of the microbiological parameters from baseline at 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- 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.
Tiago Ribeiro-Amaral, Dr principal investigator
University of Lisbon
Paulo Macaranhas, PhD study director
University of Lisbon
Vanessa Rocha Rodrigues, Dr study chair
University of Lisbon
Questions about this trial
What is this clinical trial studying?
A study testing Implants are decontaminated with electrolytic cleaning and Implants are decontaminated without electrolytic cleaning in people with Peri-Implantitis, run by University of Lisbon.
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 6 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: status not confirmed, as of the sponsor's last update on 24 Jun 2022. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vanessa Rocha Rodrigues, Dr (919950890 ext. +351, vanessa_15_rodrigues@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probing pocket depth (time frame: Assessing the change of probing pocket depth from baseline at 3 months, 6 months and 12 months). The study lists 5 primary outcomes in all. 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 24 Jun 2022.