Clinical trial NCT05187663: Evaluation of Photodynamic Therapy in Treatment of Peri-implantitis
Official title: The Evaluation of Clinical, Microbiological and Immunological Parameters After Using Photodynamic Therapy in the Surgical Treatment of Peri-implantitis: Randomized Clinical Trials.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peri-Implantitis
Keywords: Peri-Implantitis, Photodynamic therapy, Surgery
Lead sponsor: University of Belgrade
Sponsor class: OTHER
Collaborators: name: Military Medical Academy, Bulgaria
name: Bredent Medical, Helbo
First posted: 2022-01-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of bleeding on probing (BOP)
timeFrame: Change baseline BOP at 12 months
measure: Change of bleeding on probing (BOP)
timeFrame: Change baseline BOP at 24 months
Secondary outcomes:
measure: Change of peri-implant probing depths (PPD)
timeFrame: Change baseline PPD at 12 months
measure: Change of peri-implant probing depths (PPD)
timeFrame: Change baseline PPD at 24 months
measure: Change of clinical attachment gain (CAG)
timeFrame: Change baseline CAL at 12 months
measure: Change of clinical attachment gain (CAG)
timeFrame: Change baseline CAL at 24 months
Other outcomes:
measure: Concentration of interleukin 17 (IL-17)
timeFrame: Change baseline concentration of IL-17 at 12 months
measure: Concentration of interleukin 17 (IL-17)
timeFrame: Change baseline concentration of IL-17 at 24 months
measure: Concentration of interleukin 1 beta (IL-1beta)
timeFrame: Change baseline concentration of IL-1beta at 12 months
measure: Concentration of interleukin 1 beta (IL-1beta)
timeFrame: Change baseline concentration of IL-1beta at 24 months
measure: Concentration of interleukin 6 (IL-6)
timeFrame: Change baseline concentration of IL-6 at 12 months
measure: Concentration of interleukin 6 (IL-6)
timeFrame: Change baseline concentration of IL-6 at 24 months
Locations:
city: Belgrade
country: Serbia
facility: Department of Periodontal and Oral Mucosa Diseases
Study officials:
References:
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.
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.
citation: 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.
citation: 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.
citation: Froum SJ, Rosen PS. A proposed classification for peri-implantitis. Int J Periodontics Restorative Dent. 2012 Oct;32(5):533-40.