Non-surgical Electrolytic Cleaning Peri-implantitis

Universidad Complutense de Madrid

Status

Active, not recruiting

Conditions

Peri-Implantitis

Treatments

Drug: Antibiotic treatment (Metronidazole)

Procedure: Modification and polishing of the prosthesis

Procedure: Implant surface decontamination 3 (electrolytic cleaning)

Behavioral: Implant hygiene instructions and removal of the prosthesis

Procedure: Implant surface decontamination 1(ultrasonic device)

Procedure: Implant surface decontamination 2 (air polishing)

Procedure: Non-surgical peri-implantitis treatment /microsurgery

Study type

Interventional

Funder types

Other

Identifiers

NCT05275894

UCM ACA

Details and patient eligibility

About

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.

Full 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.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.
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 design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

25 participants in 1 patient group

Non-surgical electrolytic cleaning

Experimental group

Description:

* 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.