Non-surgical Electrolytic Cleaning Peri-implantitis

• Status: Not yet recruiting
• Trial end date: 2023-07-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad Complutense de Madrid
• Treatments: Anti-Bacterial Agents; Metronidazole

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