Evaluation of Photodynamic Therapy in Treatment of Peri-implantitis

Peri-Implantitis Clinical Trial

— PDT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05187663
• Other study ID #: 39/28
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: May 2017

Study information

• Verified date: December 2021
• Source: University of Belgrade
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. More than 18 years old

2. No periodontal or peri-implant treatment in the last 3 months prior to the study

3. Presence of a minimum of one implant in function more than one year with signs of early and moderate peri-implantitis

4. Prosthetic rehabilitation of the implant with diagnosed peri-implantitis more than 6 months

5. Presence of peri-implant pocket depth more than 4 mm

6. Radiogrpih bone level loss more than 2 mm 7 Positive sign of bleeding on probing with or without suppuration

Exclusion Criteria:

1. Uncontrolled medical conditions

2. Use of systemic antibiotics in the previous 3 months

3. Use of anti-inflammatory drugs in the previous 6 months

Related Conditions & MeSH terms

• Peri-Implantitis

Intervention

Procedure:
• Photodynamic (PDT) group
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.
• Chlorhexidine (CHX) group
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.

Locations

Country	Name	City	State
Serbia	Department of Periodontal and Oral Mucosa Diseases	Belgrade

Sponsors (3)

Lead Sponsor	Collaborator
University of Belgrade	Bredent Medical, Helbo, Military Medical Academy

Country where clinical trial is conducted

Serbia, 

References & Publications (5)

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. — View Citation

Dörtbudak 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. — View Citation

Froum SJ, Rosen PS. A proposed classification for peri-implantitis. Int J Periodontics Restorative Dent. 2012 Oct;32(5):533-40. — View Citation

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. — View Citation

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. Erratum in: Lasers Med Sci. 2013 May;28(3):1047. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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 24 months
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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