Non-surgical Electrolytic Cleaning Peri-implantitis

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Peri-Implantitis
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ana Carillo de Albornoz Sainz; Phone Number: +34627588248; Email: acarill02@ucm.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: Implant hygiene instructions and removal of the prosthesis; Verbal instructions on implant hygiene practices and removal of the implant supported prosthesis; Procedure: 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; Procedure: Implant surface decontamination 1(ultrasonic device); Removal of supra and submucosal calculus with slim ultrasonic devices (Piezon PS instrument EMS; Nyon, Swiss).; Procedure: 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: 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.; Drug: Antibiotic treatment (Metronidazole); Antibiotic treatment (Metronidazole 500 mg, every day/ 7 day).; Other Names: Metronidazole; Procedure: Modification and polishing of the prosthesis; If necessary, modification and polishing of the prosthesis to make it cleanable.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	12 months
Implant plaque index at 6 months	Implant plaque index (PI) (at 6 sites/implant)(+/-).	6 months
Implant plaque index at 12 months	Implant plaque index (PI) (at 6 sites/implant)(+/-).	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).	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).	12 months
Bleeding on probing at 6 months	Bleeding on probing (BOP) from the peri-implant mucosa (measured at 6 sites/implant) (+/-).	6 months
Bleeding on probing at 12 months	Bleeding on probing (BOP) from the peri-implant mucosa (measured at 6 sites/implant) (+/-).	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).	6 months
Suppuration at 12 months	Presence or absence of suppuration from the peri-implant mucosa (measured at 6 sites/implant) (+/-)	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).	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).	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.	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.	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).	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).	12 months
Overall satisfaction after 6 months	Overall satisfaction on a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant).	6 months
Overall satisfaction after 12 months	Overall satisfaction on a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant).	12 months

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Investigators: Principal Investigator: Mariano Sanz Alonso, University Complutense Madrid

Study record dates

Study Major Dates

• Study Start (Anticipated): July 15, 2022
• Primary Completion (Anticipated): July 30, 2023
• Study Completion (Anticipated): July 30, 2023

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: March 10, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): June 9, 2022
• Last Update Submitted That Met QC Criteria: June 8, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Peri-implantitis; Non-surgical treatment; Electrolytic cleaning; Implant decontamination
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis; Anti-Infective Agents; Antiprotozoal Agents; Antiparasitic Agents; Metronidazole; Anti-Bacterial Agents
• Other Study ID Numbers: UCM ACA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No