Evaluation of Photodynamic Therapy in Treatment of Peri-implantitis

Study Overview
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Brief Summary
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Photodynamic therapy (PDT) is suggested as an adjuvant treatment method to the surgery in peri-implantitis treatment. The primary goal of peri-implantitis therapy is the removal of the causative bacteria from the implant surface and surrounding tissues in order to improve the process of re-osseointegration and achieve long term implant stability. Accordingly, the aims of the study were to evaluate clinical, immunological and microbiological outcomes after surgical therapy of peri-implantitis following PDT.

Detailed Description
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Treatment procedure After clinical parameters were recorded and samples were taken, all patients underwent a single episode of non-surgical therapy. It implied a mechanical method for debridement of implants and remaining dentition in order to reduce signs of inflammation. Instructions for oral hygiene were proposed in the same visit. Peri-implantitis surgical treatment was conducted by one experienced surgeon two weeks after non-surgical therapy. After granulation tissue removal and mechanical implant surface cleaning with graphite curettes (Straumann Dental Implant System Straumann AG, Basel, Switzerland), decontamination of implant surface was conducted. In the study group, for the decontamination of implant surfaces and peri-implant tissues photodynamic therapy was performed (HELBO, Photodynamic Systems GmbH, Wels, Austria), while in the control group, after removal of granulation tissue, 1% gel of chlorhexidine (Chlorhexamed® - Direkt) was put on the implant surface. One minute after exposing the implant surface with CHX, it was irrigated for 1 min by saline. Bone augmentation and bio-resorbable membrane were applied in peri-implant defects using the bovine bone substitute and collagen membrane (Bio-Oss and Bio Gide, GeistlichPharma; Dembone). The mucoperiosteal flaps were repositioned and sutured [17, 19]. Patients were prescribed antibiotics (Amoxicillin, 500 mg, three per day, 5 days). It was recommended that patients don't use mouthwash during the postoperative period. Clinical, immunological and microbiological parameters were measured and assessed baseline, three, six, 12 and 24 months postoperatively. Immunological parameters (IL-17, IL-1β, IL-6) were analysed by ELISA while microbiological samples were collected before the therapy, during the surgery, and at follow-up periods. Assessment of implant macro- and micro- design were additionally assessed.

Official Title
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The Evaluation of Clinical, Microbiological and Immunological Parameters After Using Photodynamic Therapy in the Surgical Treatment of Peri-implantitis: Randomized Clinical Trials.

Conditions
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Peri-Implantitis

Intervention / Treatment
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* Procedure: Photodynamic (PDT) group
* Procedure: Chlorhexidine (CHX) group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: More than 18 years old No periodontal or peri-implant treatment in the last 3 months prior to the study Presence of a minimum of one implant in function more than one year with signs of early and moderate peri-implantitis Prosthetic rehabilitation of the implant with diagnosed peri-implantitis more than 6 months Presence of peri-implant pocket depth more than 4 mm Radiogrpih bone level loss more than 2 mm 7 Positive sign of bleeding on probing with or without suppuration Exclusion Criteria: Uncontrolled medical conditions Use of systemic antibiotics in the previous 3 months Use of anti-inflammatory drugs in the previous 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

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
Interventional Model Description: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Study group<br>In the test group, implant surface decontamination was performed with photodynamic therapy. | Procedure: Photodynamic (PDT) group<br>* Mucoperiostal buccal and lingual incisions were made using a surgical blade under local anaesthesia. Full-thickness mucoperiosteal flaps were elevated buccally and lingually. In the photodynamic (PDT) group, after careful removal of granulation tissue and mechanical debridement of the implant surface, decontamination of implant surfaces and peri-implant tissues was performed using the photodynamic therapy, PDT (HELBO, Photodynamic Systems GmbH, Wels, Austria). The implant surface and the surrounding tissue were exposed to the laser light by means of fibres (HELBO ® TheraLite Laser HELBO ® 2D Spot Probe; bredent medical GmbH & Co KG) for the 30s/spot, which operates on the wavelength of 660 nm and irradiance of 100 Mw. Bone augmentation and bio-resorbable membrane were applied in peri-implant defects using the bovine bone substitute and collagen membrane (Bio -Oss and Bio Guide, GeistlichPharma; Dembone). The mucoperiosteal flaps were repositioned and sutured.<br>|
| Active Comparator: Control group<br>In the control group, implant surface decontamination was performed with 1% chlorhexidine gel. | Procedure: Chlorhexidine (CHX) group<br>* Mucoperiostal buccal and lingual incisions were made using a surgical blade under local anaesthesia. Full-thickness mucoperiosteal flaps were elevated buccally and lingually. In the chlorhexidine (CHX) group, after careful removal of granulation tissue and mechanical debridement of the implant surface 1% gel of chlorhexidine (Chlorhexamed® - Direkt) was applied on the implant surface for one minute and irrigated for 1 min by saline. Bone augmentation and bio-resorbable membrane were applied in peri-implant defects using the bovine bone substitute and collagen membrane (Bio -Oss and Bio Guide, GeistlichPharma; Dembone). The mucoperiosteal flaps were repositioned and sutured.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of bleeding on probing (BOP) | Evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was observed | Change baseline BOP at 12 months | 
| Change of bleeding on probing (BOP) | Evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was observed | Change baseline BOP at 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of peri-implant probing depths (PPD) | PPD was measured in millimetres as the distance from mucosal margin to bottom of periodontal pocket. | Change baseline PPD at 12 months | 
| Change of peri-implant probing depths (PPD) | PPD was measured in millimetres as the distance from mucosal margin to bottom of periodontal pocket. | Change baseline PPD at 24 months | 
| Change of clinical attachment gain (CAG) | CAL, measured in millimetres as the distance from implant shoulder to the bottom of peri-implant pocket at six points. | Change baseline CAL at 12 months | 
| Change of clinical attachment gain (CAG) | CAL, measured in millimetres as the distance from implant shoulder to the bottom of peri-implant pocket at six points. | Change baseline CAL at 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peri-Implantitis, Photodynamic therapy, Surgery