Surgical and Non-surgical Treatment of Peri-implantitis

Study Overview
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Brief Summary
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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.

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

Conditions
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Peri-implantitis

Intervention / Treatment
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* Procedure: Surgical treatment
* Procedure: Non-surgical treatment


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pocket depth reduction |  | 12 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peri-implantitis, dental implants, randomized controlled trial, non-surgical periodontal treatment, will be defined by the presence of alveolar bone loss of at least 3mm, pocket depth of at least 5mm and bleeding on probing.