Surgical and Non-surgical Treatment of Peri-implantitis

NCT ID: NCT02241577

Last Updated: 2019-10-01

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

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2019-08-31

Brief Summary

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This study will compare surgical and non surgical treatments of peri-implantitis. Peri-implantitis is an inflammation around dental implants that can lead to the loss of the implant over time if no treatment is established. The signs of peri-implantitis included bleeding of the gingiva, swelling and redness. Most of times there is no pain. Patients presenting with these characteristics will be included at random to one of the treatment groups. Those allocated to the non-surgical group will received implant cleansing after local anesthesia using adequate instruments. In the surgical group, patients will be submitted to a surgical procedure around the implant for visualization and cleansing also after local anesthesia. All patients will be followed over a 12-month period. The hypothesis is that surgical treatment is better than non-surgical treatment regarding clinical, radiographic, microbiological, and immunological.characteristics.

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

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Surgical treatment

Surgical access for scaling and disinfection of dental implant

Group Type EXPERIMENTAL

Surgical treatment

Intervention Type PROCEDURE

Flap surgery around dental implant for scaling and disinfection of the titanium surface under local anesthesia

Non-surgical treatment

Non-surgical subgingival scaling and disinfection of dental implant

Group Type EXPERIMENTAL

Non-surgical treatment

Intervention Type PROCEDURE

Non-surgical subgingival scaling and disinfection of the titanium surface of dental implant under local anesthesia

Interventions

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Surgical treatment

Flap surgery around dental implant for scaling and disinfection of the titanium surface under local anesthesia

Intervention Type PROCEDURE

Non-surgical treatment

Non-surgical subgingival scaling and disinfection of the titanium surface of dental implant under local anesthesia

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Individuals with at least one dental implant with peri-implantitits
* Individuals with good general health conditions;
* Individuals presenting at least 10 natural teeth;
* Individuals with no signs of active periodontitis

Exclusion Criteria

* Individuals who received periodontal treatment in the last three months
* Pregnant
* Systemic condition that interferes with treatment such as diabetes
* Individuals who are taking or have taken antibiotics or anti-inflammatory medication
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Rio Grande do Sul

OTHER

Sponsor Role lead

Responsible Party

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Alex Nogueira Haas

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cassiano K Rosing, PhD

Role: STUDY_CHAIR

Federal University of Rio Grande do Sul

Joao Augusto P Oliveira, MS

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Tassiane P Wagner, DDS

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Fernando S Rios, MS

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Ricardo SA Costa, MS

Role: PRINCIPAL_INVESTIGATOR

Federal University of Rio Grande do Sul

Locations

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Alex Haas

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Related Links

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http://www.ufrgs.br/odonto

Site of the School of Dentistry

http://www.ufrgs.br/ppgodo/index.php

Site of the Post-graduate Program in Dentistry

Other Identifiers

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CNPq14_2013

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UFRGSimplant2014

Identifier Type: -

Identifier Source: org_study_id

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