Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
25 participants
INTERVENTIONAL
2022-10-12
2024-12-30
Brief Summary
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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
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Non-surgical electrolytic cleaning
* 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.
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).
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.
Antibiotic treatment (Metronidazole)
Antibiotic treatment (Metronidazole 500 mg, every day/ 7 day).
Modification and polishing of the prosthesis
If necessary, modification and polishing of the prosthesis to make it cleanable.
Implant hygiene instructions and removal of the prosthesis
Verbal instructions on implant hygiene practices and removal of the implant supported prosthesis
Non-surgical peri-implantitis treatment /microsurgery
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)
Removal of supra and submucosal calculus with slim ultrasonic devices (Piezon PS instrument EMS; Nyon, Swiss).
Interventions
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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).
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.
Antibiotic treatment (Metronidazole)
Antibiotic treatment (Metronidazole 500 mg, every day/ 7 day).
Modification and polishing of the prosthesis
If necessary, modification and polishing of the prosthesis to make it cleanable.
Implant hygiene instructions and removal of the prosthesis
Verbal instructions on implant hygiene practices and removal of the implant supported prosthesis
Non-surgical peri-implantitis treatment /microsurgery
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)
Removal of supra and submucosal calculus with slim ultrasonic devices (Piezon PS instrument EMS; Nyon, Swiss).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
* 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
* 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
18 Years
ALL
No
Sponsors
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Universidad Complutense de Madrid
OTHER
Responsible Party
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Principal Investigators
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Mariano Sanz Alonso
Role: PRINCIPAL_INVESTIGATOR
University Complutense Madrid
Locations
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Ana Carrillo de Albornoz
Madrid, , Spain
Countries
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Other Identifiers
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UCM ACA
Identifier Type: -
Identifier Source: org_study_id