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

Primary Purpose

Peri-Implantitis

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Surface decontamination procedure aiming at reconstructive therapy
Sponsored by
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peri-Implantitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion: Screw-retained or cement-retained fixed or removable implant-supported prosthesis for a minimum of 36 months. All patients in age of 18 to 80 non-smokers no presence of systemic disease or medication known to alter bone metabolism partial or complete edentulous patients that have no active periodontal disease. Exclusion criteria: pregnancy or lactation history of or current smokers uncontrolled medical conditions, lacking keratinized mucosa (≤2mm) on the lingual or buccal implant sites, advanced(A) peri-implantitis (>50% of the implant length).

Sites / Locations

  • Clinica CICOMRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Group electrolytic approach (EA)

Group hydrogen peroxide (HP)

Arm Description

Mechanical detoxification using curettes + NiTi brushes + EA (GalvoSurge) during 2 minutes

Group hydrogen peroxide (HP): Mechanical detoxification using curettes + NiTi brushes + hydrogen peroxide 5% for 2 minutes soaked in a gauze

Outcomes

Primary Outcome Measures

Resolution of the disease
No pocket depth >6mm, no bleeding on probing, no suppuration, no progressive bone loss

Secondary Outcome Measures

Radiographic bone gain
Bone gain when compared to baseline bone level

Full Information

First Posted
November 7, 2022
Last Updated
September 25, 2023
Sponsor
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
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1. Study Identification

Unique Protocol Identification Number
NCT05615051
Brief Title
Influence of Implant Surface Decontamination on the Reconstructive Outcomes of Peri-implantitis
Official Title
Influence of Implant Surface Decontamination on the Reconstructive Outcomes of Peri-implantitis: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group electrolytic approach (EA)
Arm Type
Experimental
Arm Description
Mechanical detoxification using curettes + NiTi brushes + EA (GalvoSurge) during 2 minutes
Arm Title
Group hydrogen peroxide (HP)
Arm Type
Active Comparator
Arm Description
Group hydrogen peroxide (HP): Mechanical detoxification using curettes + NiTi brushes + hydrogen peroxide 5% for 2 minutes soaked in a gauze
Intervention Type
Device
Intervention Name(s)
Surface decontamination procedure aiming at reconstructive therapy
Other Intervention Name(s)
Hydrogen peroxide
Intervention Description
Surface decontamination of infected implants followed by reconstructive therapy to manage peri-implantitis
Primary Outcome Measure Information:
Title
Resolution of the disease
Description
No pocket depth >6mm, no bleeding on probing, no suppuration, no progressive bone loss
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Radiographic bone gain
Description
Bone gain when compared to baseline bone level
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion: Screw-retained or cement-retained fixed or removable implant-supported prosthesis for a minimum of 36 months. All patients in age of 18 to 80 non-smokers no presence of systemic disease or medication known to alter bone metabolism partial or complete edentulous patients that have no active periodontal disease. Exclusion criteria: pregnancy or lactation history of or current smokers uncontrolled medical conditions, lacking keratinized mucosa (≤2mm) on the lingual or buccal implant sites, advanced(A) peri-implantitis (>50% of the implant length).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mamen Tomé, DH
Phone
924203045
Email
mtome@periocicom.com
Facility Information:
Facility Name
Clinica CICOM
City
Badajoz
ZIP/Postal Code
06011
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mamen Tomé, DH
Phone
924203045
First Name & Middle Initial & Last Name & Degree
Alberto Monje, DDS
First Name & Middle Initial & Last Name & Degree
Pedro Peña, DDS

12. IPD Sharing Statement

Learn more about this trial

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

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