Implantoplasty as Adjunct to Combined Surgical Therapy of Peri-Implantitis

NCT ID: NCT06131567

Last Updated: 2024-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2024-11-30

Brief Summary

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Implantoplasty entails polishing of the implant surface during the surgical therapy of peri-implantitis. Given the controversy behind implantoplasty as surface decontamination method in the treatment of peri-implantitis, the goal of this clinical trial is to assess the clinical resolution and radiographic bone gain in peri-implantitis sites treated by means of reconstructive therapy (Inteross® + autogenous bone, Sigmagraft, CA, USA) + implantoplasty in combined defects when compared to the extent of implantoplasty along the exposed implant surface upon the clinical resolution and radiographic bone gain in peri-implantitis sites treated by means of reconstructive therapy (Inteross® + autogenous bone, Sigmagraft, CA, USA).

Detailed Description

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Conditions

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Peri-Implantitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trials with paired number of subjects
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Implantoplasty

Implantoplasty to all the implant surface

Group Type EXPERIMENTAL

Implantoplasty

Intervention Type PROCEDURE

Implantoplasty as surface decontamination method

Implantoplasty on the supracrestal component

Implantoplasty only in the supra-crestal component and the infra bony hydrogen peroxide

Group Type ACTIVE_COMPARATOR

Implantoplasty

Intervention Type PROCEDURE

Implantoplasty as surface decontamination method

Interventions

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Implantoplasty

Implantoplasty as surface decontamination method

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients in age of 18 to 80, non-smokers
* With no presence of systemic disease or medication known to alter bone metabolism, and partial or complete edentulous patients that have no active periodontal disease.
* Peri-implantitis defined according to the EFP/AAP consensus meeting
* Combined defect configuration

Exclusion Criteria

* Pregnancy or lactation
* History of or current smokers
* Uncontrolled medical conditions,
* Cement-retained restoration
* Lacking keratinized mucosa (≤2mm) on the lingual or buccal implant sites.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain

OTHER

Sponsor Role lead

Responsible Party

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Alberto Monje

Head

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Centro de Implantologia Cirugia Oral y Maxilofacial

Badajoz, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Mamen Tome Rincon, DH

Role: CONTACT

+34924203045

Facility Contacts

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Alberto Monje, DDS, MS

Role: primary

Other Identifiers

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18102021

Identifier Type: -

Identifier Source: org_study_id

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