Surgical and Non-surgical Treatment of Peri-implantitis

Not Applicable

Completed

• Conditions: Peri-implantitis
• Interventions: Procedure: Non-surgical treatment; Procedure: Surgical treatment

• Registration Number: NCT02241577
• Lead Sponsor: Federal University of Rio Grande do Sul

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-09-12
• Study First Submitted QC: 2014-09-15
• Study First Posted: 2014-09-16
• Primary Completion: 2019-08
• Study Completion: 2019-08
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-26
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-surgical treatment	Non-surgical treatment	Non-surgical subgingival scaling and disinfection of dental implant
Surgical treatment	Surgical treatment	Surgical access for scaling and disinfection of dental implant

Primary Outcome Measures

Name	Time	Method
Pocket depth reduction	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Alex Haas; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil