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Surgical and Non-surgical Treatment of Peri-implantitis (Perio-implants)

Primary Purpose

Peri-implantitis

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Surgical treatment

Non-surgical treatment

About this trial

This is an interventional treatment trial for Peri-implantitis focused on measuring peri-implantitis, dental implants, randomized controlled trial, non-surgical periodontal treatment, will be defined by the presence of alveolar bone loss of at least 3mm, pocket depth of at least 5mm and bleeding on probing.

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Alex Haas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Surgical treatment

Non-surgical treatment

Arm Description

Surgical access for scaling and disinfection of dental implant

Non-surgical subgingival scaling and disinfection of dental implant

Outcomes

Primary Outcome Measures

Pocket depth reduction

Secondary Outcome Measures

Clinical attachment level changes

Alveolar bone level changes

Subgingival microbiota changes

Gingival crevicular fluid immune-inflammatory biomarkers

Serum biomarkers of inflammation

Bleeding on probing

Full Information

NCT ID

NCT02241577

First Posted

September 12, 2014

Last Updated

September 26, 2019

Sponsor

Federal University of Rio Grande do Sul

1. Study Identification

Unique Protocol Identification Number

NCT02241577

Brief Title

Surgical and Non-surgical Treatment of Peri-implantitis

Acronym

Perio-implants

Official Title

Surgical and Non-surgical Treatment of Peri-implantitis: Multi-center Randomised Controlled Trial of 12-months Follow-up

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

June 2014 (undefined)

Primary Completion Date

August 2019 (Actual)

Study Completion Date

August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Federal University of Rio Grande do Sul

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

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

Peri-implantitis

Keywords

peri-implantitis, dental implants, randomized controlled trial, non-surgical periodontal treatment, will be defined by the presence of alveolar bone loss of at least 3mm, pocket depth of at least 5mm and bleeding on probing.

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Surgical treatment

Arm Type

Experimental

Arm Description

Surgical access for scaling and disinfection of dental implant

Arm Title

Non-surgical treatment

Arm Type

Experimental

Arm Description

Non-surgical subgingival scaling and disinfection of dental implant

Intervention Type

Procedure

Intervention Name(s)

Surgical treatment

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Non-surgical treatment

Intervention Description

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

Primary Outcome Measure Information:

Title

Pocket depth reduction

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Clinical attachment level changes

Time Frame

12 months

Title

Alveolar bone level changes

Time Frame

12 months

Title

Subgingival microbiota changes

Time Frame

12 months

Title

Gingival crevicular fluid immune-inflammatory biomarkers

Time Frame

12 motnhs

Title

Serum biomarkers of inflammation

Time Frame

12 months

Title

Bleeding on probing

Time Frame

12 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cassiano K Rosing, PhD

Organizational Affiliation

Federal University of Rio Grande do Sul

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Joao Augusto P Oliveira, MS

Organizational Affiliation

Federal University of Rio Grande do Sul

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Tassiane P Wagner, DDS

Organizational Affiliation

Federal University of Rio Grande do Sul

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Fernando S Rios, MS

Organizational Affiliation

Federal University of Rio Grande do Sul

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ricardo SA Costa, MS

Organizational Affiliation

Federal University of Rio Grande do Sul

Official's Role

Principal Investigator

Facility Information:

Facility Name

Alex Haas

City

Porto Alegre

State/Province

Rio Grande Do Sul

ZIP/Postal Code

90630080

Country

Brazil

12. IPD Sharing Statement

Links:

URL

http://www.ufrgs.br/odonto

Description

Site of the School of Dentistry

URL

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

Description

Site of the Post-graduate Program in Dentistry

Learn more about this trial

Surgical and Non-surgical Treatment of Peri-implantitis

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