NCT05275894

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 11, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

October 12, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

November 24, 2023

Status Verified

October 1, 2023

Enrollment Period

1.5 years

First QC Date

February 2, 2022

Last Update Submit

November 22, 2023

Conditions

Peri-Implantitis

Keywords

Peri-implantitisElectrolytic cleaningImplant decontaminationNon-surgical treatment

Outcome Measures

Primary Outcomes (2)

  • 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)

    6 months

  • Peri-implant disease resolution at 12 month

    Probing depth \< 5 mm, with absence of bleeding or suppuration and no additional

    12 months

Secondary Outcomes (18)

  • Implant survival rate at 6 months

    6 months

  • Implant survival rate at 12 months

    12 months

  • Implant plaque index at 6 months

    6 months

  • Implant plaque index at 12 months

    12 months

  • Peri-implant probing depth at 6 months

    6 months

  • +13 more secondary outcomes

Study Arms (1)

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.

Behavioral: Implant hygiene instructions and removal of the prosthesisProcedure: Non-surgical peri-implantitis treatment /microsurgeryProcedure: 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

Interventions

Implant hygiene instructions and removal of the prosthesisBEHAVIORAL

Verbal instructions on implant hygiene practices and removal of the implant supported prosthesis

Non-surgical electrolytic cleaning
Non-surgical peri-implantitis treatment /microsurgeryPROCEDURE

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

Non-surgical electrolytic cleaning
Implant surface decontamination 1(ultrasonic device)PROCEDURE

Removal of supra and submucosal calculus with slim ultrasonic devices (Piezon PS instrument EMS; Nyon, Swiss).

Non-surgical electrolytic cleaning
Implant surface decontamination 2 (air polishing)PROCEDURE

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).

Non-surgical electrolytic cleaning
Implant surface decontamination 3 (electrolytic cleaning)PROCEDURE

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.

Non-surgical electrolytic cleaning
Antibiotic treatment (Metronidazole)DRUG

Antibiotic treatment (Metronidazole 500 mg, every day/ 7 day).

Also known as: Metronidazole
Non-surgical electrolytic cleaning
Modification and polishing of the prosthesisPROCEDURE

If necessary, modification and polishing of the prosthesis to make it cleanable.

Non-surgical electrolytic cleaning

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ana Carrillo de Albornoz

Madrid, 28040, Spain

Location

MeSH Terms

Conditions

Peri-Implantitis

Interventions

MicrosurgeryMetronidazole

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeMicromanipulationInvestigative TechniquesNitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Mariano Sanz Alonso

    University Complutense Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2022

First Posted

March 11, 2022

Study Start

October 12, 2022

Primary Completion

March 30, 2024

Study Completion

December 30, 2024

Last Updated

November 24, 2023

Record last verified: 2023-10

Locations

ES(1)