Reconstructive Treatment of Peri-implantitis With Electrolytic Decontamination Versus Titanium Brushes

Early Phase 1Not Yet RecruitingNCT07814391

George Eastman Dental Hospital, Italy38 enrolled

Overview

Implants diagnosed with peri-implantitis and amenable for bone reconstructive treatment will be enrolled in the study. The implants will randomly be treated with either an electrolytic or a mechanical cleaning of the implant surface (with titanium brushes). In all cases, a bone graft will be used to rebuild missing bone.

Implants diagnosed with peri-implantitis and amenable for bone reconstructive treatment will be enrolled in the study. All implants will receive reconstructive therapy by means of a collagenated bone graft, however the method of decontamination will be randomized between electrolytic cleaning or titanium rotating brushes. In both cases, titanium curettes will be used to remove hard deposits on the implant surface and degranulation will be completed with curettes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Peri-Implantitis and Peri-implant Mucositis

Interventions

test device GalvoSurgePROCEDURE

Electrolytic decontamination

Mechanical decontamination with titanium brushPROCEDURE

Reconstructive treatment of peri-implantitis after removal of hard and soft tissue deposits from the implant surface followed by mechanical decontamination with titanium brush

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Implants with peri-implantitis (defined according to 2017 World Workshop definitions) * contained defects with infra osseous component amenable to reconstructive treatment * fixed and removable superstructures * patients with no systemic conditions affecting healing (uncontrolled diabetes mellitus, chronic corticosteroid use, autoimmune conditions affecting connective tissue) * smoking more than 10 cigarettes Exclusion Criteria: * mobile implants * non removable crowns (both cement or screw retained) that cannot be removed prior to surgery

Outcomes

Primary Outcomes

Change in Probing pocket depth

distance (mm) between marginal mucosa and bottom of probable pocket

Time frame: from baseline to 12, 24 months post-surgery

Secondary Outcomes

change in recession

change between baseline and 24 months (mm)

Time frame: baseline to 12 and 24 months post-op

change in CAL

change in CAL between baseline and 24 months (mm)

Time frame: between baseline and 24 months

Suppuration on probing (SoP)

Dichotomic variable

Time frame: baseline, 12, 24 months

Bleeding on probing

Dichotomic variable (yes/ no)

Time frame: baseline, 12, 24 months

Keratinized mucosa (KM)

continuous, measured in mm, from the margin of the mucosa to the mucogingival junction

Time frame: baseline, 12, 24 months

Treatment Success

Composite outcome comprising implant not lost, no more than 1 mm of buccal recession, no more than 5 mm of PPD, no SOP, no more than 1 bleeding spot on probing, no loss of crestal bone (mm)

Time frame: 24 months

Central Contacts

Lucrezia Paterno Holtzman, DDS, MS

CONTACT

+393398035371 lucreziaph@gmail.com

Luca Cordaro, DDS MD

CONTACT

lucacordaro@usa.net

Data from ClinicalTrials.gov

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