Evaluation of Photodynamic Therapy in Treatment of Peri-implantitis (PDT)
Primary Purpose
Peri-Implantitis
Status
Completed
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
Photodynamic (PDT) group
Chlorhexidine (CHX) group
Sponsored by
About this trial
This is an interventional treatment trial for Peri-Implantitis focused on measuring Peri-Implantitis, Photodynamic therapy, Surgery
Eligibility Criteria
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
Sites / Locations
- Department of Periodontal and Oral Mucosa Diseases
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Study group
Control group
Arm Description
In the test group, implant surface decontamination was performed with photodynamic therapy.
In the control group, implant surface decontamination was performed with 1% chlorhexidine gel.
Outcomes
Primary Outcome Measures
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 of bleeding on probing (BOP)
Evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was observed
Secondary Outcome Measures
Change of peri-implant probing depths (PPD)
PPD was measured in millimetres as the distance from mucosal margin to bottom of periodontal pocket.
Change of peri-implant probing depths (PPD)
PPD was measured in millimetres as the distance from mucosal margin to bottom of periodontal pocket.
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 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.
Full Information
NCT ID
NCT05187663
First Posted
December 12, 2021
Last Updated
December 26, 2021
Sponsor
University of Belgrade
Collaborators
Military Medical Academy, Bredent Medical, Helbo
1. Study Identification
Unique Protocol Identification Number
NCT05187663
Brief Title
Evaluation of Photodynamic Therapy in Treatment of Peri-implantitis
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Belgrade
Collaborators
Military Medical Academy, Bredent Medical, Helbo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis
Keywords
Peri-Implantitis, Photodynamic therapy, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double (Participant, Investigator, Sub-investigator) Single Blind
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Active Comparator
Arm Description
In the test group, implant surface decontamination was performed with photodynamic therapy.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
In the control group, implant surface decontamination was performed with 1% chlorhexidine gel.
Intervention Type
Procedure
Intervention Name(s)
Photodynamic (PDT) group
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Chlorhexidine (CHX) group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of bleeding on probing (BOP)
Description
Evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was observed
Time Frame
Change baseline BOP at 12 months
Title
Change of bleeding on probing (BOP)
Description
Evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was observed
Time Frame
Change baseline BOP at 24 months
Secondary Outcome Measure Information:
Title
Change of peri-implant probing depths (PPD)
Description
PPD was measured in millimetres as the distance from mucosal margin to bottom of periodontal pocket.
Time Frame
Change baseline PPD at 12 months
Title
Change of peri-implant probing depths (PPD)
Description
PPD was measured in millimetres as the distance from mucosal margin to bottom of periodontal pocket.
Time Frame
Change baseline PPD at 24 months
Title
Change of clinical attachment gain (CAG)
Description
CAL, measured in millimetres as the distance from implant shoulder to the bottom of peri-implant pocket at six points.
Time Frame
Change baseline CAL at 12 months
Title
Change of clinical attachment gain (CAG)
Description
CAL, measured in millimetres as the distance from implant shoulder to the bottom of peri-implant pocket at six points.
Time Frame
Change baseline CAL at 24 months
Other Pre-specified Outcome Measures:
Title
Concentration of interleukin 17 (IL-17)
Description
Measurement of pro-inflammatory IL-17 concentration before and after the treatment procedure.
Time Frame
Change baseline concentration of IL-17 at 12 months
Title
Concentration of interleukin 17 (IL-17)
Description
Measurement of pro-inflammatory IL-17 concentration before and after the treatment procedure.
Time Frame
Change baseline concentration of IL-17 at 24 months
Title
Concentration of interleukin 1 beta (IL-1beta)
Description
Measurement of pro-inflammatory IL-1beta concentration before and after the treatment procedure.
Time Frame
Change baseline concentration of IL-1beta at 12 months
Title
Concentration of interleukin 1 beta (IL-1beta)
Description
Measurement of pro-inflammatory IL-1beta concentration before and after the treatment procedure.
Time Frame
Change baseline concentration of IL-1beta at 24 months
Title
Concentration of interleukin 6 (IL-6)
Description
Measurement of pro-inflammatory IL-6 concentration before and after the treatment procedure.
Time Frame
Change baseline concentration of IL-6 at 12 months
Title
Concentration of interleukin 6 (IL-6)
Description
Measurement of pro-inflammatory IL-6 concentration before and after the treatment procedure.
Time Frame
Change baseline concentration of IL-6 at 24 months
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
> 18 years of age
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Department of Periodontal and Oral Mucosa Diseases
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
22092831
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.
Results Reference
background
PubMed Identifier
22790655
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.
Results Reference
background
PubMed Identifier
11251658
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.
Results Reference
background
PubMed Identifier
24861411
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.
Results Reference
background
PubMed Identifier
22754901
Citation
Froum SJ, Rosen PS. A proposed classification for peri-implantitis. Int J Periodontics Restorative Dent. 2012 Oct;32(5):533-40.
Results Reference
background
Available IPD and Supporting Information:
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://pubmed.ncbi.nlm.nih.gov/29652462/
Available IPD/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.
Learn more about this trial
Evaluation of Photodynamic Therapy in Treatment of Peri-implantitis
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