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Clinical Trials/NCT02241577
NCT02241577
Completed
N/A

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

Federal University of Rio Grande do Sul1 site in 1 country70 target enrollmentJune 2014

Overview

Phase
N/A
Intervention
Not specified
Conditions
Peri-implantitis
Sponsor
Federal University of Rio Grande do Sul
Enrollment
70
Locations
1
Primary Endpoint
Pocket depth reduction
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
August 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of Rio Grande do Sul
Responsible Party
Principal Investigator
Principal Investigator

Alex Nogueira Haas

Associate Professor

Federal University of Rio Grande do Sul

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
  • Systemic condition that interferes with treatment such as diabetes
  • Individuals who are taking or have taken antibiotics or anti-inflammatory medication

Outcomes

Primary Outcomes

Pocket depth reduction

Time Frame: 12 months

Secondary Outcomes

  • Clinical attachment level changes(12 months)
  • Gingival crevicular fluid immune-inflammatory biomarkers(12 motnhs)
  • Bleeding on probing(12 months)
  • Serum biomarkers of inflammation(12 months)
  • Alveolar bone level changes(12 months)
  • Subgingival microbiota changes(12 months)

Study Sites (1)

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