Surgical and Non-surgical Treatment of Peri-implantitis

Peri-implantitis Clinical Trial

— Perio-implants  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02241577
• Other study ID #: UFRGSimplant2014
• Secondary ID: CNPq14_2013
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: August 2019

Study information

• Verified date: September 2019
• Source: Federal University of Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Peri-implantitis

Intervention

Procedure:
• Surgical treatment
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 the titanium surface of dental implant under local anesthesia

Locations

Country	Name	City	State
Brazil	Alex Haas	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Rio Grande do Sul

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pocket depth reduction		12 months
Secondary	Clinical attachment level changes		12 months
Secondary	Alveolar bone level changes		12 months
Secondary	Subgingival microbiota changes		12 months
Secondary	Gingival crevicular fluid immune-inflammatory biomarkers		12 motnhs
Secondary	Serum biomarkers of inflammation		12 months
Secondary	Bleeding on probing		12 months

External Links

•   Site of the School of Dentistry