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| Name | Class |
|---|---|
| Military Medical Academy, Bulgaria | OTHER |
| Bredent Medical, Helbo | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Active Comparator | In the test group, implant surface decontamination was performed with photodynamic therapy. |
|
| Control group | Active Comparator | In the control group, implant surface decontamination was performed with 1% chlorhexidine gel. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photodynamic (PDT) group | Procedure | 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. |
| 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 |
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of interleukin 17 (IL-17) | Measurement of pro-inflammatory IL-17 concentration before and after the treatment procedure. | Change baseline concentration of IL-17 at 12 months |
| Concentration of interleukin 17 (IL-17) |
Inclusion Criteria:
Exclusion Criteria:
> 18 years of age
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Periodontal and Oral Mucosa Diseases | Belgrade | 11000 | Serbia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22092831 | Background | Heitz-Mayfield LJA, Salvi GE, Mombelli A, Faddy M, Lang NP. Anti-infective surgical therapy of peri-implantitis. A 12-month prospective clinical study. Clin Oral Implants Res. 2012 Feb;23(2):205-210. doi: 10.1111/j.1600-0501.2011.02276.x. Epub 2011 Aug 9. | |
| 22790655 | Background | Marotti J, Tortamano P, Cai S, Ribeiro MS, Franco JE, de Campos TT. Decontamination of dental implant surfaces by means of photodynamic therapy. Lasers Med Sci. 2013 Jan;28(1):303-9. doi: 10.1007/s10103-012-1148-6. Epub 2012 Jul 12. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
Gained results are planned to be published in international journal.
From 2022. to 2032.
The investigators will be shared analyzed outcomes and surgical procedure protocols
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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Not provided
| ID | Term |
|---|---|
| C008848 | 1-phenyl-3,3-dimethyltriazene |
| D044382 | Population Groups |
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
| D001645 | Biguanides |
| D006146 | Guanidines |
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Parallel Assignment
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Double (Participant, Investigator, Sub-investigator) Single Blind
|
| Chlorhexidine (CHX) group | Procedure | 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. |
|
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 |
Measurement of pro-inflammatory IL-17 concentration before and after the treatment procedure.
| Change baseline concentration of IL-17 at 24 months |
| Concentration of interleukin 1 beta (IL-1beta) | Measurement of pro-inflammatory IL-1beta concentration before and after the treatment procedure. | Change baseline concentration of IL-1beta at 12 months |
| Concentration of interleukin 1 beta (IL-1beta) | Measurement of pro-inflammatory IL-1beta concentration before and after the treatment procedure. | Change baseline concentration of IL-1beta at 24 months |
| Concentration of interleukin 6 (IL-6) | Measurement of pro-inflammatory IL-6 concentration before and after the treatment procedure. | Change baseline concentration of IL-6 at 12 months |
| Concentration of interleukin 6 (IL-6) | Measurement of pro-inflammatory IL-6 concentration before and after the treatment procedure. | Change baseline concentration of IL-6 at 24 months |
| 11251658 | Background | Dortbudak O, Haas R, Bernhart T, Mailath-Pokorny G. Lethal photosensitization for decontamination of implant surfaces in the treatment of peri-implantitis. Clin Oral Implants Res. 2001 Apr;12(2):104-8. doi: 10.1034/j.1600-0501.2001.012002104.x. |
| 24861411 | Background | de Waal YC, Raghoebar GM, Meijer HJ, Winkel EG, van Winkelhoff AJ. Implant decontamination with 2% chlorhexidine during surgical peri-implantitis treatment: a randomized, double-blind, controlled trial. Clin Oral Implants Res. 2015 Sep;26(9):1015-23. doi: 10.1111/clr.12419. Epub 2014 May 26. |
| 22754901 | Background | Froum SJ, Rosen PS. A proposed classification for peri-implantitis. Int J Periodontics Restorative Dent. 2012 Oct;32(5):533-40. |
Rakašević D, Lazić Z, Rakonjac B, Soldatović I, Janković S, Magić M, Aleksić Z. Efficiency of photodynamic therapy in the treatment of peri-implantitis - A three-month randomized controlled clinical trial. Srp Arh Celok Lek. 2016 Sep-Oct;144(9-10):478-84. PMID: 29652462. |
| D000578 |
| Amidines |
| D009930 | Organic Chemicals |