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Completed

NCT Number: NCT05187663

Evaluation of Photodynamic Therapy in Treatment of Peri-implantitis

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Periodontal and Oral Mucosa Diseases

Belgrade, 11000, Serbia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change of bleeding on probing (BOP)

    Time frame: Change baseline BOP at 12 months

    Evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was observed

  2. Change of bleeding on probing (BOP)

    Time frame: Change baseline BOP at 24 months

    Evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was observed

Secondary outcomes

  1. Change of peri-implant probing depths (PPD)

    Time frame: Change baseline PPD at 12 months

    PPD was measured in millimetres as the distance from mucosal margin to bottom of periodontal pocket.

  2. Change of peri-implant probing depths (PPD)

    Time frame: Change baseline PPD at 24 months

    PPD was measured in millimetres as the distance from mucosal margin to bottom of periodontal pocket.

  3. Change of clinical attachment gain (CAG)

    Time frame: Change baseline CAL at 12 months

    CAL, measured in millimetres as the distance from implant shoulder to the bottom of peri-implant pocket at six points.

  4. Change of clinical attachment gain (CAG)

    Time frame: Change baseline CAL at 24 months

    CAL, measured in millimetres as the distance from implant shoulder to the bottom of peri-implant pocket at six points.

Other outcomes

  1. Concentration of interleukin 17 (IL-17)

    Time frame: Change baseline concentration of IL-17 at 12 months

    Measurement of pro-inflammatory IL-17 concentration before and after the treatment procedure.

  2. Concentration of interleukin 17 (IL-17)

    Time frame: Change baseline concentration of IL-17 at 24 months

    Measurement of pro-inflammatory IL-17 concentration before and after the treatment procedure.

  3. Concentration of interleukin 1 beta (IL-1beta)

    Time frame: Change baseline concentration of IL-1beta at 12 months

    Measurement of pro-inflammatory IL-1beta concentration before and after the treatment procedure.

  4. Concentration of interleukin 1 beta (IL-1beta)

    Time frame: Change baseline concentration of IL-1beta at 24 months

    Measurement of pro-inflammatory IL-1beta concentration before and after the treatment procedure.

  5. Concentration of interleukin 6 (IL-6)

    Time frame: Change baseline concentration of IL-6 at 12 months

    Measurement of pro-inflammatory IL-6 concentration before and after the treatment procedure.

  6. Concentration of interleukin 6 (IL-6)

    Time frame: Change baseline concentration of IL-6 at 24 months

    Measurement of pro-inflammatory IL-6 concentration before and after the treatment procedure.

Sponsors and collaborators

Lead sponsor

University of Belgrade

Other

Collaborators

  • Bredent Medical, Helbo
  • Military Medical Academy, Bulgaria

Registry information

Official study title

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

Acronym: PDT

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Jan 12, 2022
Registry last updated
Jan 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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