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

September 26, 2019 updated by: Alex Nogueira Haas, Federal University of Rio Grande do Sul

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90630080
        • Alex Haas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Surgical treatment
Surgical access for scaling and disinfection of dental implant
Procedure: Surgical treatment
Flap surgery around dental implant for scaling and disinfection of the titanium surface under local anesthesia
EXPERIMENTAL: Non-surgical treatment
Non-surgical subgingival scaling and disinfection of dental implant
Procedure: Non-surgical treatment
Non-surgical subgingival scaling and disinfection of the titanium surface of dental implant under local anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pocket depth reduction
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical attachment level changes
Time Frame: 12 months
12 months
Alveolar bone level changes
Time Frame: 12 months
12 months
Subgingival microbiota changes
Time Frame: 12 months
12 months
Gingival crevicular fluid immune-inflammatory biomarkers
Time Frame: 12 motnhs
12 motnhs
Serum biomarkers of inflammation
Time Frame: 12 months
12 months
Bleeding on probing
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Rio Grande do Sul

Investigators

  • Study Chair: Cassiano K Rosing, PhD, Federal University of Rio Grande do Sul
  • Principal Investigator: Joao Augusto P Oliveira, MS, Federal University of Rio Grande do Sul
  • Principal Investigator: Tassiane P Wagner, DDS, Federal University of Rio Grande do Sul
  • Principal Investigator: Fernando S Rios, MS, Federal University of Rio Grande do Sul
  • Principal Investigator: Ricardo SA Costa, MS, Federal University of Rio Grande do Sul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (ACTUAL)

August 1, 2019

Study Completion (ACTUAL)

August 1, 2019

Study Registration Dates

First Submitted

September 12, 2014

First Submitted That Met QC Criteria

September 15, 2014

First Posted (ESTIMATE)

September 16, 2014

Study Record Updates

Last Update Posted (ACTUAL)

October 1, 2019

Last Update Submitted That Met QC Criteria

September 26, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UFRGSimplant2014
  • CNPq14_2013 (OTHER_GRANT: CNPq (Brazilian Counsel for Research))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Peri-implantitis

Clinical Trials on Surgical treatment

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe