Evaluation of Photodynamic Therapy in Treatment of Peri-implantitis

NCT05187663 | Completed DMC

• 1 other identifier: 39/28
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-Implantitis

Keywords

Peri-Implantitis, Photodynamic therapy, Surgery

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (4)

• Change of peri-implant probing depths (PPD)

  Change baseline PPD at 12 months

• Change of peri-implant probing depths (PPD)

  Change baseline PPD at 24 months

• Change of clinical attachment gain (CAG)

  Change baseline CAL at 12 months

• Change of clinical attachment gain (CAG)

  Change baseline CAL at 24 months

Other Outcomes (6)

• Concentration of interleukin 17 (IL-17)

  Change baseline concentration of IL-17 at 12 months

• Concentration of interleukin 17 (IL-17)

  Change baseline concentration of IL-17 at 24 months

• Concentration of interleukin 1 beta (IL-1beta)

  Change baseline concentration of IL-1beta at 12 months

Study Arms (2)

Study group

ACTIVE COMPARATOR

In the test group, implant surface decontamination was performed with photodynamic therapy.

Procedure: Photodynamic (PDT) group

Control group

ACTIVE COMPARATOR

In the control group, implant surface decontamination was performed with 1% chlorhexidine gel.

Procedure: Chlorhexidine (CHX) group

Interventions

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.

Study group

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.

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Gender Eligibility Details: \> 18 years of age
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Uncontrolled medical conditions
• Use of systemic antibiotics in the previous 3 months
• Use of anti-inflammatory drugs in the previous 6 months

Sponsors & Collaborators

• University of Belgrade: lead
• Military Medical Academy, Bulgaria: collaborator
• Bredent Medical, Helbo: collaborator

Study Sites (1)

Department of Periodontal and Oral Mucosa Diseases

Belgrade, 11000, Serbia

Location

Related Publications (5)

• 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.

  PMID: 22092831 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.

  PMID: 22790655 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.

  PMID: 11251658 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.

  PMID: 24861411 BACKGROUND

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

  PMID: 22754901 BACKGROUND

MeSH Terms

Conditions

Peri-Implantitis

Interventions

1-phenyl-3,3-dimethyltriazene; Population Groups; Chlorhexidine

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double (Participant, Investigator, Sub-investigator) Single Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Specialist of periodontology

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: December 12, 2021
• First Posted: January 12, 2022
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: May 1, 2017
• Last Updated: January 12, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From 2022. to 2032.
• Access Criteria: The investigators will be shared analyzed outcomes and surgical procedure protocols

Locations

SE (1)