Skip to main content
OpenTrials
Completed

NCT Number: NCT02241577

Surgical and Non-surgical Treatment of Peri-implantitis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alex Haas

Porto Alegre, Rio Grande do Sul, 90630080, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

surgical treatment

Procedure

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

Non-surgical treatment

Procedure

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

Primary outcomes

  1. Pocket depth reduction

    Time frame: 12 months

Secondary outcomes

  1. Clinical attachment level changes

    Time frame: 12 months

  2. Alveolar bone level changes

    Time frame: 12 months

  3. Subgingival microbiota changes

    Time frame: 12 months

  4. Gingival crevicular fluid immune-inflammatory biomarkers

    Time frame: 12 motnhs

  5. Serum biomarkers of inflammation

    Time frame: 12 months

  6. Bleeding on probing

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Federal University of Rio Grande do Sul

Other

Registry information

Official study title

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

Acronym: Perio-implants

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Sep 16, 2014
Registry last updated
Oct 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.