Non-surgical Electrolytic Cleaning Peri-implantitis

Peri-Implantitis Clinical Trial

Official title:

Non-surgical Treatment of Peri-implantitis With Electrolytic Cleaning: a Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05275894
• Other study ID #: UCM ACA
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 12, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: October 2023
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 25
• Est. completion date: December 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

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
• Implant surface decontamination 1(ultrasonic device)
Removal of supra and submucosal calculus with slim ultrasonic devices (Piezon PS instrument EMS; Nyon, Swiss).
• 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.

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

Procedure:
• Modification and polishing of the prosthesis
If necessary, modification and polishing of the prosthesis to make it cleanable.

Locations

Country	Name	City	State
Spain	Ana Carrillo de Albornoz	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Peri-implant disease resolution at 12 month	Probing depth < 5 mm, with absence of bleeding or suppuration and no additional	12 months
Secondary	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
Secondary	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
Secondary	Implant plaque index at 6 months	Implant plaque index (PI) (at 6 sites/implant)(+/-).	6 months
Secondary	Implant plaque index at 12 months	Implant plaque index (PI) (at 6 sites/implant)(+/-).	12 months
Secondary	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
Secondary	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
Secondary	Bleeding on probing at 6 months	Bleeding on probing (BOP) from the peri-implant mucosa (measured at 6 sites/implant) (+/-).	6 months
Secondary	Bleeding on probing at 12 months	Bleeding on probing (BOP) from the peri-implant mucosa (measured at 6 sites/implant) (+/-).	12 months
Secondary	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
Secondary	Suppuration at 12 months	Presence or absence of suppuration from the peri-implant mucosa (measured at 6 sites/implant) (+/-)	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Overall satisfaction after 6 months	Overall satisfaction on a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant).	6 months
Secondary	Overall satisfaction after 12 months	Overall satisfaction on a 5 options semi-quantitative scale (very nice, nice, regular, unpleasant, very unpleasant).	12 months