Regenerative Surgical Treatment of Peri-implant Defects

Study Overview
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Brief Summary
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Does submerged healing of implants improve clinical and radiologic outcomes for the treatment of peri-implantitis? A number of recent systematic reviews have shown that the prevalence of periimplantitisin the population is high. Nevertheless, there appears to be no consensus on treatment standards for the management of peri-implant diseases. Also, the significant variation in the empirical use of the available therapeutic modalities seems to result in moderately effective treatment outcomes. Animal and human case series-studies have shown improved outcomes when using a submerged healing approach. However, there seems to be no randomized controlled clinical studies comparing submerged/non-submerged healing efficacy for the treatment of peri-implantitis. Since current modalities for the treatment of peri-implantitis seem to result inmoderately effective outcomes, there is an urgency to investigate treatment strategies that will result in improved patient's benefits in terms of health.

Detailed Description
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The present study will be double-blinded randomized controlled clinical trial. Patients requiring surgical treatment of peri-implantitis after non-surgical therapy will beassigned to either: Test group: submerged healing or Control group: non-submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane. The primary aim of this study is to evaluate whether submerged healing of implants willsignificantly improve the changes in marginal bone levels measured on X-rays 12months post-treatment compared to a non-submerged healing approach for the treatment of peri-implantitis. Secondary aims include changes in clinical attachment levels, changes in probing pocket depth, recession, keratinized tissue, occurrence of bleeding on probing, suppuration on probing (PUS), marginal gingival recession (REC), full mouth plaque score (FMPS), full mouth bleeding score (FMBS), type of peri-implant bone defect, frequency and type of complications and implant loss.

Official Title
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Regenerative Surgical Treatment of Peri-implant Defects. Submerged Versus Not Submerged

Conditions
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Implant Site Pocket Infection

Intervention / Treatment
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* Procedure: regenerative treatment periimplantitis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years. Systemically healthy patients. Presence of at least 1 implant diagnosed with peri-implantitis (peri-implant probing pocket depth ≥6 mm in at least 1 aspect of the implant with bleeding and/or suppuration on probing and radiographically documented marginal bone loss ≥3mm) according to Renvert et al. (2018), after non-surgical therapy of periimplantitis, and a 4mm deep intrabony component. Absence of mobility of the implants. Individual implant-supported crown or partial fixed implant supported restoration (removable prosthesis will be excluded). Patient's smoking ≤ 10 cigarettes/day. Exclusion Criteria: Non-removable prostheses

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: Test group: submerged healing Control group: non-submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane. | Procedure: regenerative treatment periimplantitis<br>* Full thickness buccal and lingual flaps will be performed. After debridement of the defect using hand and ultrasonic instruments and implant surface decontamination using titanium brushes (TiBrush®) and saline Regenerative treatment will be performed only in the intrabony component of type 1 peri-implant defects. Guided bone regeneration using a bone substitute (Bio-oss®) and a resorbable membrane (bio-gide®) will be performed in the intrabony and dehiscenses areas of the defect. The surgeon will be blinded to the assignment of treatment until it is time to close the flaps.<br>|
| Experimental: Control group<br>non submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane. | Procedure: regenerative treatment periimplantitis<br>* Full thickness buccal and lingual flaps will be performed. After debridement of the defect using hand and ultrasonic instruments and implant surface decontamination using titanium brushes (TiBrush®) and saline Regenerative treatment will be performed only in the intrabony component of type 1 peri-implant defects. Guided bone regeneration using a bone substitute (Bio-oss®) and a resorbable membrane (bio-gide®) will be performed in the intrabony and dehiscenses areas of the defect. The surgeon will be blinded to the assignment of treatment until it is time to close the flaps.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes marginal bone level | measured on periapical X-rays, from the shoulder of the implant to the bottom of the bone defect next to the implant at the mesial and distal surfaces. Mean marginal bone levels between mesial and distal measurements will be calculated. | baseline, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes Probing pocket depth | distance from the margin gingival to the bottom of the peri-implant pouch. All clinical variables will be recorded with a Hu-friedy CP15 UNC millimeter probe in six points on each implant. | baseline, 6 and 12 months | 
| Changes Clinical attachment level | Distance from the implant shoulder or prosthetic abutment to the bottom of the peri-implant pocket. | baseline, 6 and 12 months | 
| Change Reccesion | distance from the margin of the peri-implant mucosa to the implant / abutment interface. | baseline, 6 and 12 months | 
| Change Keratinized mucosa | distance from the gingival margin up to the mucogingival line. | baseline, 6 and 12 months | 
| Change blending on probing | Registry of presence of bleeding by binary scale (1 bleed present / 0 bleed absent) | baseline, 6 and 12 months | 
| Change supuration | Pus presence register by scale binary (1 present / 0 absent) | baseline, 6 and 12 months | 
| Change plaque score | Registration of presence of plaque by binary scale on each surface (1 present / 0 absent), calculating the percentage of total surfaces in which plaque is detected by using a periodontal probe | baseline, 6 and 12 months | 
| configuration of the bone defect | Based on the classification of Schwarz et al. (2007) | baseline |