Evaluation of Photodynamic Therapy in Treatment of Peri-implantitis (PDT)
December 26, 2021 updated by: Dragana Rakasevic, University of Belgrade
The Evaluation of Clinical, Microbiological and Immunological Parameters After Using Photodynamic Therapy in the Surgical Treatment of Peri-implantitis: Randomized Clinical Trials.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Belgrade, Serbia, 11000
- Department of Periodontal and Oral Mucosa Diseases
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: Study group
In the test group, implant surface decontamination was performed with photodynamic therapy.
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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.
|
|
Active Comparator: Control group
In the control group, implant surface decontamination was performed with 1% chlorhexidine gel.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change of bleeding on probing (BOP)
Time Frame: Change baseline BOP at 12 months
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Evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was observed
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Change baseline BOP at 12 months
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Change of bleeding on probing (BOP)
Time Frame: Change baseline BOP at 24 months
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Evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was observed
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Change baseline BOP at 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change of peri-implant probing depths (PPD)
Time Frame: Change baseline PPD at 12 months
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PPD was measured in millimetres as the distance from mucosal margin to bottom of periodontal pocket.
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Change baseline PPD at 12 months
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Change of peri-implant probing depths (PPD)
Time Frame: Change baseline PPD at 24 months
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PPD was measured in millimetres as the distance from mucosal margin to bottom of periodontal pocket.
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Change baseline PPD at 24 months
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Change of clinical attachment gain (CAG)
Time Frame: Change baseline CAL at 12 months
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CAL, measured in millimetres as the distance from implant shoulder to the bottom of peri-implant pocket at six points.
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Change baseline CAL at 12 months
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Change of clinical attachment gain (CAG)
Time Frame: Change baseline CAL at 24 months
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CAL, measured in millimetres as the distance from implant shoulder to the bottom of peri-implant pocket at six points.
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Change baseline CAL at 24 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Concentration of interleukin 17 (IL-17)
Time Frame: Change baseline concentration of IL-17 at 12 months
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Measurement of pro-inflammatory IL-17 concentration before and after the treatment procedure.
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Change baseline concentration of IL-17 at 12 months
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Concentration of interleukin 17 (IL-17)
Time Frame: Change baseline concentration of IL-17 at 24 months
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Measurement of pro-inflammatory IL-17 concentration before and after the treatment procedure.
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Change baseline concentration of IL-17 at 24 months
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Concentration of interleukin 1 beta (IL-1beta)
Time Frame: Change baseline concentration of IL-1beta at 12 months
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Measurement of pro-inflammatory IL-1beta concentration before and after the treatment procedure.
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Change baseline concentration of IL-1beta at 12 months
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Concentration of interleukin 1 beta (IL-1beta)
Time Frame: Change baseline concentration of IL-1beta at 24 months
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Measurement of pro-inflammatory IL-1beta concentration before and after the treatment procedure.
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Change baseline concentration of IL-1beta at 24 months
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Concentration of interleukin 6 (IL-6)
Time Frame: Change baseline concentration of IL-6 at 12 months
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Measurement of pro-inflammatory IL-6 concentration before and after the treatment procedure.
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Change baseline concentration of IL-6 at 12 months
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Concentration of interleukin 6 (IL-6)
Time Frame: Change baseline concentration of IL-6 at 24 months
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Measurement of pro-inflammatory IL-6 concentration before and after the treatment procedure.
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Change baseline concentration of IL-6 at 24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Froum SJ, Rosen PS. A proposed classification for peri-implantitis. Int J Periodontics Restorative Dent. 2012 Oct;32(5):533-40.
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2014
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
May 1, 2017
Study Registration Dates
First Submitted
December 12, 2021
First Submitted That Met QC Criteria
December 26, 2021
First Posted (Actual)
January 12, 2022
Study Record Updates
Last Update Posted (Actual)
January 12, 2022
Last Update Submitted That Met QC Criteria
December 26, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 39/28
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
Gained results are planned to be published in international journal.
IPD Sharing Time Frame
From 2022. to 2032.
IPD Sharing Access Criteria
The investigators will be shared analyzed outcomes and surgical procedure protocols
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Informed Consent Form (ICF)
- Clinical Study Report (CSR)
Study Data/Documents
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Study Protocol
Information comments: 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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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