Surgical Treatment of Peri-implantitis

Study Overview
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Brief Summary
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The aim of this randomized controlled study is to evaluate the outcome of surgical treatment of peri-implantitis with and without the use of a bone substitute graft covered by a collagen membrane. There will be a follow up period of 12 months. Outcome measures will include assessments of inflammation, probing depth, recession, radiological parameters and PROMs.

Detailed Description
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The aim of this randomized controlled study is to evaluate the possible benefit of a regenerative treatment protocol (placing a bone substitute covered by a bioresorbable collagen membrane) compared to surgical treatment alone, for peri-implantitis therapy. The hypothesis is that there will be a greater number of patients with successful treatment of peri-implantitis following the use of a bone substitute/collagen membrane compared to surgical peri-implantitis therapy without the bone substitute/collagen membrane. The project will be conducted as a two-armed randomized controlled clinical trial of 1-year duration. Forty systemically healthy patients with ≥1 implant diagnosed with peri-implantitis requiring surgical therapy will be enrolled. Baseline measurements will be performed after non-surgical therapy (removal supramucosal biofilm/calculus, oral hygiene instruction and correction of prosthetic factors) and treatment of periodontitis. Baseline measurements will include probing depth, position of mucosal margin, presence of plaque, presence of bleeding and/or suppuration on probing, PROMs and radiographs. Measurements will be recorded at 4 sites per implant. Following the baseline measurements participants will be randomly assigned to either Control Group (Group 1): access flap and implant cleaning or Test Group (Group 2): access flap, implant cleaning and addition of a bone substitute material covered by a collagen membrane. Participants in both treatment groups will be prescribed systemic antimicrobials (Amoxicillin 500 mg tds and Metronidazole 400 mg tds) for 7 days starting from the day of surgery. In addition an antibacterial mouthrinse (chlorhexidine digluconate 0.2%) will be prescribed for a period of 4 weeks following surgery. Participants will be asked to attend follow-up visits for review of healing (week 1 and 4) and maintenance care (3, 6, 9, and 12 months). Clinical examinations will be performed by a calibrated blinded examiner at baseline and 12 months after therapy. Clinical measurements will be taken using a periodontal probe at 4 sites per implant to record presence of plaque, bleeding, probing depth and recession of the soft tissue. PROMS will be assessed at 1 week, 4 weeks and at 12 months. Radiographic assessments Intra-oral radiographs and cone beam CT scan will be obtained prior to surgery and at 12 months. Oral-maxillofacial radiologists will. perform the radiographic analysis and will be blinded to the treatment procedure. Primary outcome variables include (1) resolution of peri-implantitis (probing depth reduction and absence of BoP, suppuration) (2) recurrence of disease (BoP, suppuration and increase in PPD and progression of bone loss.

Official Title
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Surgical Treatment of Peri-implantitis. A Randomised Controlled Trial.

Conditions
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Peri-Implantitis

Intervention / Treatment
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* Drug: Control group
* Device: Test group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of ≥ 1 implant with a probing depth (PD) ≥ 5 mm with bleeding and/or suppuration (SUP) on probing, and peri-implant bone loss ≥ 3mm with an intraosseous defect component Exclusion Criteria: Smokers > 10 cigarettes per day Patients with uncontrolled diabetes mellitus Pregnant or lactating women (self reported) Patients with a systemic illness that preclude them from oral surgery Patients with an allergy to amoxicillin or metronidazole or chlorhexidine. Patients requiring antibiotic prophylaxis and Patients who have taken antibiotics in the past 3 months

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group 1<br>Access flap, implant surface decontamination (saline), systemic antibiotics (amoxicillin 500 mg and metronidazole 400 g, 3 x day for 7 days) | Drug: Control group<br>* Access flap and debridement<br>* Other names: Access flap and debridement;|
| Active Comparator: Test Group 2<br>Access flap, implant surface debridement, systemic antibiotics (amoxicillin 500 mg, metronidazole 400 g, 3 x day for 7 days), bovine bone substitute material (BioOss®) and collagen membrane (BioGide®) | Device: Test group<br>* Regenerative treatment<br>* Other names: BioOss®, BioGide® collagen membrane;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Success Outcome | Number of participants with treated implant with successful outcome: no bleeding or suppuration on probing, no further bone loss, PD ≤ 5 mm | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| probing depth change | mm | 12 months | 
| radiographic bone level change | mm | 12 months | 
| change in peri-implant soft tissue level | mm | 12 months | 
| patient reported outcomes | VAS scores | 1, 6, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peri-Implantitis, Infection, Bone substitutes