Clinical trial NCT05275894: Non-surgical Electrolytic Cleaning Peri-implantitis
Official title: Non-surgical Treatment of Peri-implantitis With Electrolytic Cleaning: a Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Peri-Implantitis
Keywords: Peri-implantitis
Electrolytic cleaning
Implant decontamination
Non-surgical treatment
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2022-03-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Peri-implant disease resolution at 6 month
timeFrame: 6 months
measure: Peri-implant disease resolution at 12 month
timeFrame: 12 months
Secondary outcomes:
measure: Implant survival rate at 6 months
timeFrame: 6 months
measure: Implant survival rate at 12 months
timeFrame: 12 months
measure: Implant plaque index at 6 months
timeFrame: 6 months
measure: Implant plaque index at 12 months
timeFrame: 12 months
measure: Peri-implant probing depth at 6 months
timeFrame: 6 months
measure: Peri-implant probing depth at 12 months
timeFrame: 12 months
measure: Bleeding on probing at 6 months
timeFrame: 6 months
measure: Bleeding on probing at 12 months
timeFrame: 12 months
measure: Suppuration at 6 months
timeFrame: 6 months
measure: Suppuration at 12 months
timeFrame: 12 months
measure: Recession of the mucosal margin at 6 months
timeFrame: 6 months
measure: Recession of the mucosal margin at 12 months
timeFrame: 12 months
measure: Bone loss at 6 months
timeFrame: 6 months
measure: Bone loss at 12 months
timeFrame: 12 months
measure: Patient centred outcomes of the electrolytic cleaning after 6 months
timeFrame: 6 months
measure: Patient centred outcomes of the electrolytic cleaning after 12 months
timeFrame: 12 months
measure: Overall satisfaction after 6 months
timeFrame: 6 months
measure: Overall satisfaction after 12 months
timeFrame: 12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Ana Carrillo de Albornoz
Study officials:
affiliation: University Complutense Madrid
name: Mariano Sanz Alonso
role: PRINCIPAL_INVESTIGATOR
References: