Influence of Implant Surface Decontamination on the Reconstructive Outcomes of Peri-implantitis

Not Applicable

Active, not recruiting

• Conditions: Peri-Implantitis
• Interventions: Device: Surface decontamination procedure aiming at reconstructive therapy

• Registration Number: NCT05615051
• Lead Sponsor: Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

Brief Summary

Two groups are aimed at being investigated in three centers (CICOM, Clinica Branemark and Clinica Joan Pi)

* Test group: Group electrolytic approach (EA): Mechanical detoxification using curettes + NiTi brushes + EA (GalvoSurge) during 2 minutes

* Control group: Group hydrogen peroxide (HP): Mechanical detoxification using curettes + NiTi brushes + hydrogen peroxide 5% for 2 minutes soaked in a gauze Patients´ group selection will be randomly allocated. For patients whom their personal clinical record # ends in a number from 0 to 4 will be included in the test group, while for patients whom their personal clinical record # ends from 5-9 will be included in the control group.

The infra-osseous component will be regenerated using xenograft (Creos, NB) + autogenous bone in a ratio 1:1 harvested from the adjacent area. A resorbable membrane (Creos, NB) will be placed to compartmentalize the infra-osseous component following a poncho-like approach.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-01
• Study First Submitted: 2022-11-07
• Study First Submitted QC: 2022-11-11
• Study First Posted: 2022-11-14
• Primary Completion: 2023-12-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-27
• Last Update Posted: 2024-04-30
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group hydrogen peroxide (HP)	Surface decontamination procedure aiming at reconstructive therapy	Group hydrogen peroxide (HP): Mechanical detoxification using curettes + NiTi brushes + hydrogen peroxide 5% for 2 minutes soaked in a gauze
Group electrolytic approach (EA)	Surface decontamination procedure aiming at reconstructive therapy	Mechanical detoxification using curettes + NiTi brushes + EA (GalvoSurge) during 2 minutes

Primary Outcome Measures

Name	Time	Method
Resolution of the disease	12 months	No pocket depth \>6mm, no bleeding on probing, no suppuration, no progressive bone loss

Secondary Outcome Measures

Name	Time	Method
Radiographic bone gain	12 months	Bone gain when compared to baseline bone level

Trial Locations

Locations (1)

Clinica CICOM; 🇪🇸 Badajoz, Spain