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

ConditionPeri-Implantitis and Peri-implant Mucositis
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGeorge Eastman Dental Hospital, Italy

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

mobile implants

non removable crowns (both cement or screw retained) that cannot be removed prior to surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • test device GalvoSurge

    Procedure/Surgery

    Electrolytic decontamination

  • Mechanical decontamination with titanium brush

    Procedure/Surgery

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

Treatment groups

38 Participants
are divided into 2 treatment groups
Group A: Test: Electrolytic decontaminationExperimental treatment 1 intervention
Group B: Control: Mechanical decontamination with rotating titanium brushExperimental treatment 0 interventions

Trial outcomes

Primary outcomes

1

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

1

change in recession

change between baseline and 24 months (mm)

Time frame
baseline to 12 and 24 months post-op
2

change in CAL

change in CAL between baseline and 24 months (mm)

Time frame
between baseline and 24 months
3

Suppuration on probing (SoP)

Dichotomic variable

Time frame
baseline, 12, 24 months
4

Bleeding on probing

Dichotomic variable (yes/ no)

Time frame
baseline, 12, 24 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

George Eastman Dental Hospital, Italy

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: