Evaluation of Photodynamic Therapy in Treatment of Peri-implantitis

Not Applicable

Completed

• Conditions: Peri-Implantitis
• Interventions: Procedure: Photodynamic (PDT) group; Procedure: Chlorhexidine (CHX) group

• Registration Number: NCT05187663
• Lead Sponsor: University of Belgrade

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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2016-12
• Study Completion: 2017-05
• Status Verified: 2021-12
• Study First Submitted: 2021-12-12
• Study First Submitted QC: 2021-12-26
• Last Update Submitted: 2021-12-26
• Study First Posted: 2022-01-12
• Last Update Posted: 2022-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	Photodynamic (PDT) group	In the test group, implant surface decontamination was performed with photodynamic therapy.
Control group	Chlorhexidine (CHX) group	In the control group, implant surface decontamination was performed with 1% chlorhexidine gel.

Primary Outcome Measures

Name	Time	Method
Change of bleeding on probing (BOP)	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 Outcome Measures

Name	Time	Method
Change of peri-implant probing depths (PPD)	Change baseline PPD at 24 months	PPD was measured in millimetres as the distance from mucosal margin to bottom of periodontal pocket.
Change of clinical attachment gain (CAG)	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.

Trial Locations

Locations (1)

Department of Periodontal and Oral Mucosa Diseases; 🇷🇸 Belgrade, Serbia