Peri-ImplantitisNCT05275894
Non-surgical Electrolytic Cleaning Peri-implantitis
A study testing Implant hygiene instructions and removal of the prosthesis, Non-surgical peri-implantitis treatment /microsurgery and Implant surface decontamination 1(ultrasonic device) in people with Peri-Implantitis, run by Universidad Complutense de Madrid at 1 site in Spain.
Trial summary
Electrolytic cleaning is a promising treatment for dental implant decontamination, but this mode of therapy has not yet been clinically tested as an adjunct to the non-surgical treatment of periimplantitis. 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?
- Implant hygiene instructions and removal of the prosthesis, Non-surgical peri-implantitis treatment /microsurgery and Implant surface decontamination 1(ultrasonic device)
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 12 Oct 2022to 30 Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female age > 18 years.
- Presence of at least 1 implant with the diagnose of peri-implantitis (Berglundh et al. 2018; Renvert et al. 2018)
- Peri-implant bone loss < 2/3
- History of treated periodontal diseases (Caton 2018).
- Screw retained prosthesis that can be easily unscrewed.
- Prosthesis that allows access to biofilm control by the patient, or which can be modified accordingly.
- Absence of implant mobility
Who cannot join
- Systemic exclusion criteria
- Pregnant or lactating women Non-surgical electrolytic cleaning CONFIDENTIAL
- Patients chronically treated (i.e., two weeks or more) with any medication known to affect periodontal/peri-implant status (i.e., antibiotics intake within 3 months prior to the initiation)
- Medical conditions requiring prolonged use of steroids and/or with medications that could interfere with bone metabolism.
- History of leukocyte dysfunction and deficiencies.
- History of neoplastic disease requiring the use of radiation or chemotherapy.
Show all 18Show fewer
- Patients with chronic renal failure requiring dialysis.
- Patients with metabolic bone disorders such as osteoporosis treated with antiresoptive medications.
- History of uncontrolled endocrine disorders: hypothyroidism or diabetes.
- Physical handicaps that would interfere with the ability to perform adequate oral hygiene or patients unable to use daily interproximal cleaning.
- Alcoholism or drug abuse.
- History of immunodeficiency syndromes.
- Tobacco consumption (smoking more than 10 cigarettes per day)
- Conditions or circumstances, which in the opinion of the investigator, would avoid the completion of study participation, or interfere with analysis of study results, such as history of non-compliance or unreliability, or do have any additional medical condition that contraindicates non-surgical treatment
- Local exclusion criteria
- Mucosal diseases such as erosive lichen planus in the area to be treated.
- History of local irradiation therapy.
- Implants with peri-implant bone loss beyond 2/3 of the implant length
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-surgical Treatment of Peri-implantitis With Electrolytic Cleaning: a Pilot Study
Electrolytic cleaning is a promising treatment for dental implant decontamination, but this mode of therapy has not yet been clinically tested as an adjunct to the non-surgical treatment of periimplantitis.
A prospective clinical and radiographic case series study will be performed to evaluate the clinical performance of the adjunctive use of electrolytic cleaning as an adjunct to a non-surgical therapy protocol that includes curettage of the peri-implant soft tissue. This is study is a proof of principle study, thus, a case series study is selected to start with. If the results of this case series study are favourable, a future study with a clinical trial design is then planned to do.
Read the detailed description
Electrolytic cleaning is a promising treatment for dental implant decontamination, but this mode of therapy has not yet been clinically tested as an adjunct to the non-surgical treatment of periimplantitis. Electrolytic cleaning is a promising treatment for dental implant decontamination, but this mode of therapy has not yet been clinically tested as an adjunct to the non-surgical treatment of periimplantitis.This is study is a proof of principle study, thus, a case series study is selected to start with. As this is a pilot study to test for the first time the electrolytic cleaning under non-surgical therapy, the sample size has been estimated in a minimum of 25 patients. If the results of this case series study are favourable, a future study with a clinical trial design is then planned to do.
Therapeutic success is defined as as a composite index (Sanz \& Chapple 2012 criteria of disease resolution) that includes: (1) probing pocket depth < 5 mm, (2) no bleeding on probing/suppuration and (3) no additional bone loss, at 6 and 12 months). Secondary objectives are: Changes in the clinical outcomes measurements.Changes in the radiological outcomes measurements. Changes in the patient-reported outcomes (PROMs). Evaluation of the outcomes related to the prosthetic restoration.
This study will be carried out in the following centers:
- Postgraduate Periodontal Clinic at the Faculty of Odontology-Universidad Complutense of Madrid (Spain)
- CEOSA-Madrid Private Dental Centre
After the non-surgical therapy, patients will be recalled for control visits, with supra- gingival removal of biofilm with air polishing without anaesthesia at:
- 3 months.
- 6 months.
- 12 months. After non-surgical therapy, patients will be included in a strict peri-implant maintenance therapy program to avoid re-contamination of the affected implants. Removal of biofilm with air polishing without anaesthesia and oral hygiene instruction reinforcement will be performed at: 3 months, 6 months, 9 months and 12 months.
- Conditions
- Peri-Implantitis
- Being tested
- Implant hygiene instructions and removal of the prosthesis, Non-surgical peri-implantitis treatment /microsurgery, Implant surface decontamination 1(ultrasonic device), Implant surface decontamination 2 (air polishing), Implant surface decontamination 3 (electrolytic cleaning)
- Keywords
- Peri-implantitis, Electrolytic cleaning, Implant decontamination, Non-surgical treatment
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant hygiene instructions and removal of the prosthesisBehavioural
Verbal instructions on implant hygiene practices and removal of the implant supported prosthesis
Non-surgical peri-implantitis treatment /microsurgeryProcedure or surgery
Removal of the granulation tissue and mucosa and bone defect curettage with a steel curette 4R/4L (Hu-Friedy, Chicago, IL, USA) after applying local anestesia
Implant surface decontamination 1(ultrasonic device)Procedure or surgery
Removal of supra and submucosal calculus with slim ultrasonic devices (Piezon PS instrument EMS; Nyon, Swiss).
Implant surface decontamination 2 (air polishing)Procedure or surgery
Erythritol air powder-spray system (Air-flow ® master piezon, EMS, Nyon swiss) implant surface treatment. This will be performed by separating the soft tissue with the aim of a periodontal probe (CP 15, Hu-Friedy, Chicago, IL, USA).
Implant surface decontamination 3 (electrolytic cleaning)Procedure or surgery
Electrolytic cleaning of the implant surface following manufacturer's instructions (GalvoSurge Dental AG, Widnau, Switzerland), with the help of a non-metal periodontal probe to separate the soft tissues and aim the implant surface in all its length.
Antibiotic treatment (Metronidazole)Drug
Also called Metronidazole
Antibiotic treatment (Metronidazole 500 mg, every day/ 7 day).
Modification and polishing of the prosthesisProcedure or surgery
If necessary, modification and polishing of the prosthesis to make it cleanable.
| Study group | Role | What they receive |
|---|---|---|
| Non-surgical electrolytic cleaning | Experimental | * Implant hygiene instructions and removal of the prosthesis
* Local anaesthesia
* Removal of the granulation tissue and mucosa and bone defect curettage with a steel curette 4R/4L (Hu-Friedy, Chicago, IL, USA)
* Removal of supra and submucosal calculus with slim ultrasonic devices (Piezon PS instrument EMS; Nyon, Swiss).
* Erythritol air powder-spray system (Air-flow ® master piezon, EMS, Nyon swiss) implant surface treatment. This will be performed by separating the soft tissue with the aim of a periodontal probe (CP 15, Hu-Friedy, Chicago, IL, USA).
* Electrolytic cleaning of the implant surface following manufacturer's instructions (GalvoSurge Dental AG, Widnau, Switzerland), with the help of a non-metal periodontal probe to separate the soft tissues and aim the implant surface in all its length.
* Antibiotic treatment (Metronidazole 500 mg, every day/ 7 day).
* If necessary, modification and polishing of the prosthesis to make it cleanable. Receives: Behavioral: Implant hygiene instructions and removal of the prosthesis; Procedure: Non-surgical peri-implantitis treatment /microsurgery; Procedure: Implant surface decontamination 1(ultrasonic device); Procedure: Implant surface decontamination 2 (air polishing); Procedure: Implant surface decontamination 3 (electrolytic cleaning); Drug: Antibiotic treatment (Metronidazole); Procedure: Modification and polishing of the prosthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-implant disease resolution at 6 month
Probing depth < 5 mm, with absence of bleeding or suppuration and no additional bone loss (Sanz \& Chapple 2012)
Measured: 6 months
Peri-implant disease resolution at 12 month
Probing depth < 5 mm, with absence of bleeding or suppuration and no additional
Measured: 12 months
Secondary outcomes (18)
Implant survival rate at 6 months
Survival of installed implants as defined by Misch et al., 2007: presence in the mouth, no mobility, no pain upon function, radiographic bone loss less than 1⁄2, no uncontrolled infection.
Measured: 6 months
Implant survival rate at 12 months
Survival of installed implants as defined by Misch et al., 2007: presence in the mouth, no mobility, no pain upon function, radiographic bone loss less than 1⁄2, no uncontrolled infection.
Measured: 12 months
Implant plaque index at 6 months
Implant plaque index (PI) (at 6 sites/implant)(+/-).
Measured: 6 months
Implant plaque index at 12 months
Implant plaque index (PI) (at 6 sites/implant)(+/-).
Measured: 12 months
Peri-implant probing depth at 6 months
Peri-implant probing depth (PD) (at 6 sites/implant) recorded using a CPC-15 periodontal probe at 6 sites/implant (Hu-Friedy, Leinmen, Germany).
Measured: 6 months
Peri-implant probing depth at 12 months
Peri-implant probing depth (PD) (at 6 sites/implant) recorded using a CPC-15 periodontal probe at 6 sites/implant (Hu-Friedy, Leinmen, Germany).
Measured: 12 months
Bleeding on probing at 6 months
Bleeding on probing (BOP) from the peri-implant mucosa (measured at 6 sites/implant) (+/-).
Measured: 6 months
Bleeding on probing at 12 months
Bleeding on probing (BOP) from the peri-implant mucosa (measured at 6 sites/implant) (+/-).
Measured: 12 months
Suppuration at 6 months
Presence or absence of suppuration from the peri-implant mucosa (measured at 6 sites/implant) (+/-) nice, regular, unpleasant, very unpleasant).
Measured: 6 months
Suppuration at 12 months
Presence or absence of suppuration from the peri-implant mucosa (measured at 6 sites/implant) (+/-)
Measured: 12 months
Recession of the mucosal margin at 6 months
Recession of the mucosal margin, keratinized mucosa (at 6 sites/implant) (+/-).recorded using a CPC-15 periodontal probe at 6 sites/implant (Hu-Friedy, Leinmen, Germany).
Measured: 6 months
Recession of the mucosal margin at 12 months
Recession of the mucosal margin, keratinized mucosa (at 6 sites/implant) (+/-).recorded using a CPC-15 periodontal probe at 6 sites/implant (Hu-Friedy, Leinmen, Germany).
Measured: 12 months
Bone loss at 6 months
Distance between bone crest and implant shoulder at mesial and distal site. For standardization of the periapical radiographs the same film holder-beam aiming device will be applied to each treated implant (i.e. Rinn System, RWT window x-ray system or Non-surgical electrolytic cleaning CONFIDENTIAL similar). The radiographs will be taken with the film placed parallel to the implants and the x-ray beam directed perpendicular to the implants. The quality/contrast should be good enough to clearly identify the complete implant and its essential structures.
Digital radiographs will be evaluated using a software (OsiriX Imaging Software, Pixmeo, Geneva, Switzerland) calibrating the distances with implant wide and length.
Measured: 6 months
Bone loss at 12 months
Distance between bone crest and implant shoulder at mesial and distal site. For standardization of the periapical radiographs the same film holder-beam aiming device will be applied to each treated implant (i.e. Rinn System, RWT window x-ray system or Non-surgical electrolytic cleaning CONFIDENTIAL similar). The radiographs will be taken with the film placed parallel to the implants and the x-ray beam directed perpendicular to the implants. The quality/contrast should be good enough to clearly identify the complete implant and its essential structures.
Digital radiographs will be evaluated using a software (OsiriX Imaging Software, Pixmeo, Geneva, Switzerland) calibrating the distances with implant wide and length.
Measured: 12 months
Patient centred outcomes of the electrolytic cleaning after 6 months
Patient centred outcomes of the electrolytic cleaning with a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant).
Measured: 6 months
Patient centred outcomes of the electrolytic cleaning after 12 months
Patient centred outcomes of the electrolytic cleaning with a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant).
Measured: 12 months
Overall satisfaction after 6 months
Overall satisfaction on a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant).
Measured: 6 months
Overall satisfaction after 12 months
Overall satisfaction on a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant).
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 posted11 Mar 2022
- Study start12 Oct 2022
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Dec 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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mariano Sanz Alonso, Principal investigator, University Complutense Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05275894
- Sponsor's protocol ID
- UCM ACA
- Status last verified
- Oct 2023
- First submitted
- 2 Feb 2022
- Last updated
- 24 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-surgical Treatment of Peri-implantitis With Electrolytic Cleaning: a Pilot Study
- ClinicalTrials.gov ID
- NCT05275894
- Acronym / sponsor ID
- UCM ACA
- Conditions
- Peri-Implantitis
- Keywords
- Peri-implantitis, Electrolytic cleaning, Implant decontamination, Non-surgical treatment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 11 Mar 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.
Electrolytic cleaning is a promising treatment for dental implant decontamination, but this mode of therapy has not yet been clinically tested as an adjunct to the non-surgical treatment of periimplantitis.
A prospective clinical and radiographic case series study will be performed to evaluate the clinical performance of the adjunctive use of electrolytic cleaning as an adjunct to a non-surgical therapy protocol that includes curettage of the peri-implant soft tissue. This is study is a proof of principle study, thus, a case series study is selected to start with. If the results of this case series study are favourable, a future study with a clinical trial design is then planned to do.
Detailed description
Electrolytic cleaning is a promising treatment for dental implant decontamination, but this mode of therapy has not yet been clinically tested as an adjunct to the non-surgical treatment of periimplantitis. Electrolytic cleaning is a promising treatment for dental implant decontamination, but this mode of therapy has not yet been clinically tested as an adjunct to the non-surgical treatment of periimplantitis.This is study is a proof of principle study, thus, a case series study is selected to start with. As this is a pilot study to test for the first time the electrolytic cleaning under non-surgical therapy, the sample size has been estimated in a minimum of 25 patients. If the results of this case series study are favourable, a future study with a clinical trial design is then planned to do.
Therapeutic success is defined as as a composite index (Sanz \& Chapple 2012 criteria of disease resolution) that includes: (1) probing pocket depth < 5 mm, (2) no bleeding on probing/suppuration and (3) no additional bone loss, at 6 and 12 months). Secondary objectives are: Changes in the clinical outcomes measurements.Changes in the radiological outcomes measurements. Changes in the patient-reported outcomes (PROMs). Evaluation of the outcomes related to the prosthetic restoration.
This study will be carried out in the following centers:
- Postgraduate Periodontal Clinic at the Faculty of Odontology-Universidad Complutense of Madrid (Spain)
- CEOSA-Madrid Private Dental Centre
After the non-surgical therapy, patients will be recalled for control visits, with supra- gingival removal of biofilm with air polishing without anaesthesia at:
- 3 months.
- 6 months.
- 12 months. After non-surgical therapy, patients will be included in a strict peri-implant maintenance therapy program to avoid re-contamination of the affected implants. Removal of biofilm with air polishing without anaesthesia and oral hygiene instruction reinforcement will be performed at: 3 months, 6 months, 9 months and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Non-surgical electrolytic cleaning | Experimental | Behavioral: Implant hygiene instructions and removal of the prosthesis, Procedure: Non-surgical peri-implantitis treatment /microsurgery, Procedure: Implant surface decontamination 1(ultrasonic device), Procedure: Implant surface decontamination 2 (air polishing), Procedure: Implant surface decontamination 3 (electrolytic cleaning), Drug: Antibiotic treatment (Metronidazole), Procedure: Modification and polishing of the prosthesis* Implant hygiene instructions and removal of the prosthesis * Local anaesthesia * Removal of the granulation tissue and mucosa and bone defect curettage with a steel curette 4R/4L (Hu-Friedy, Chicago, IL, USA) * Removal of supra and submucosal calculus with slim ultrasonic devices (Piezon PS instrument EMS; Nyon, Swiss). * Erythritol air powder-spray system (Air-flow ® master piezon, EMS, Nyon swiss) implant surface treatment. This will be performed by separating the soft tissue with the aim of a periodontal probe (CP 15, Hu-Friedy, Chicago, IL, USA). * Electrolytic cleaning of the implant surface following manufacturer's instructions (GalvoSurge Dental AG, Widnau, Switzerland), with the help of a non-metal periodontal probe to separate the soft tissues and aim the implant surface in all its length. * Antibiotic treatment (Metronidazole 500 mg, every day/ 7 day). * If necessary, modification and polishing of the prosthesis to make it cleanable. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female age > 18 years.
- Presence of at least 1 implant with the diagnose of peri-implantitis (Berglundh et al. 2018; Renvert et al. 2018)
- Peri-implant bone loss < 2/3
- History of treated periodontal diseases (Caton 2018).
- Screw retained prosthesis that can be easily unscrewed.
Key exclusion criteria (18 listed)
- Systemic exclusion criteria
- Pregnant or lactating women Non-surgical electrolytic cleaning CONFIDENTIAL
- Patients chronically treated (i.e., two weeks or more) with any medication known to affect periodontal/peri-implant status (i.e., antibiotics intake within 3 months prior to the initiation)
- Medical conditions requiring prolonged use of steroids and/or with medications that could interfere with bone metabolism.
- History of leukocyte dysfunction and deficiencies.
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 |
|---|---|---|
| Implant hygiene instructions and removal of the prosthesisVerbal instructions on implant hygiene practices and removal of the implant supported prosthesis | Behavioural | Non-surgical electrolytic cleaning |
| Non-surgical peri-implantitis treatment /microsurgeryRemoval of the granulation tissue and mucosa and bone defect curettage with a steel curette 4R/4L (Hu-Friedy, Chicago, IL, USA) after applying local anestesia | Procedure or surgery | Non-surgical electrolytic cleaning |
| Implant surface decontamination 1(ultrasonic device)Removal of supra and submucosal calculus with slim ultrasonic devices (Piezon PS instrument EMS; Nyon, Swiss). | Procedure or surgery | Non-surgical electrolytic cleaning |
| Implant surface decontamination 2 (air polishing)Erythritol air powder-spray system (Air-flow ® master piezon, EMS, Nyon swiss) implant surface treatment. This will be performed by separating the soft tissue with the aim of a periodontal probe (CP 15, Hu-Friedy, Chicago, IL, USA). | Procedure or surgery | Non-surgical electrolytic cleaning |
| Implant surface decontamination 3 (electrolytic cleaning)Electrolytic cleaning of the implant surface following manufacturer's instructions (GalvoSurge Dental AG, Widnau, Switzerland), with the help of a non-metal periodontal probe to separate the soft tissues and aim the implant surface in all its length. | Procedure or surgery | Non-surgical electrolytic cleaning |
| Antibiotic treatment (Metronidazole)Also: MetronidazoleAntibiotic treatment (Metronidazole 500 mg, every day/ 7 day). | Drug | Non-surgical electrolytic cleaning |
| Modification and polishing of the prosthesisIf necessary, modification and polishing of the prosthesis to make it cleanable. | Procedure or surgery | Non-surgical electrolytic cleaning |
Primary outcome
Peri-implant disease resolution at 6 month
Time frame: 6 months
Probing depth < 5 mm, with absence of bleeding or suppuration and no additional bone loss (Sanz \& Chapple 2012)
Peri-implant disease resolution at 12 month
Time frame: 12 months
Probing depth < 5 mm, with absence of bleeding or suppuration and no additional
18 secondary outcomes
Implant survival rate at 6 months
Time frame: 6 months
Implant survival rate at 12 months
Time frame: 12 months
Implant plaque index at 6 months
Time frame: 6 months
Implant plaque index at 12 months
Time frame: 12 months
Peri-implant probing depth at 6 months
Time frame: 6 months
Peri-implant probing depth at 12 months
Time frame: 12 months
Bleeding on probing at 6 months
Time frame: 6 months
Bleeding on probing at 12 months
Time frame: 12 months
Suppuration at 6 months
Time frame: 6 months
Suppuration at 12 months
Time frame: 12 months
Recession of the mucosal margin at 6 months
Time frame: 6 months
Recession of the mucosal margin at 12 months
Time frame: 12 months
Bone loss at 6 months
Time frame: 6 months
Bone loss at 12 months
Time frame: 12 months
Patient centred outcomes of the electrolytic cleaning after 6 months
Time frame: 6 months
Patient centred outcomes of the electrolytic cleaning after 12 months
Time frame: 12 months
Overall satisfaction after 6 months
Time frame: 6 months
Overall satisfaction after 12 months
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
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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 principal investigator
University Complutense Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implant hygiene instructions and removal of the prosthesis, Non-surgical peri-implantitis treatment /microsurgery and Implant surface decontamination 1(ultrasonic device) in people with Peri-Implantitis, run by Universidad Complutense de Madrid 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 7 inclusion and 18 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 Nov 2023. 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?
Results are not available in the source record.
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?
Peri-implant disease resolution at 6 month (time frame: 6 months). 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?
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 Nov 2023.