Anti-infective Effect of Non-surgical Treatment With and Without Photodynamic Therapy on Initial Peri-implantitis

NCT ID: NCT02848482

Last Updated: 2019-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2019-05-01

Brief Summary

Photodynamic therapy (PDT), also known as photoradiation therapy, phototherapy, or photochemotherapy, involves the use of a photoactive dye (photosensitizer) that is activated by exposure to light of a specific wavelength in the presence of oxygen. In recent years, PDT has been introduced as an important novel disinfection therapy in the field of implant dentistry. The inactivation of microorganisms using PDT has been defined as antimicrobial PDT. PDT has the potential to be an alternative of antibiotics, especially for the treatment of localized infections and oral biofilm. PDT is unlikely to cause bacterial-resistance and is equally effective against antibiotic-resistance and antibiotic-susceptible bacteria.

Inconsistent results have been reported regarding the potential role of PDT as an adjunct to mechanical debridement in the management of peri-implant infection. Thus, the aim of the present trial is to investigate the treatment effect of non-surgical treatment with and without photodynamic therapy on initial peri-implantitis.

Conditions

Peri-implantitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control group

Plastic curette will be used to perform the mechanical debridement. Then, irrigation (2% chlorhexidine) will be performed at contaminated sites.

Group Type: ACTIVE_COMPARATOR

Mechanical debridement

Intervention Type: PROCEDURE

Plastic scalers (Have implantrecallset, Kerr, Italy) will be used to curette the contaminated sites.

Irrigation

Intervention Type: DRUG

0.2% chlorhexidine digluconate solution (Bioworld, Madision, US) will be irrigated at contaminated sites for 1 minute.

Test group

Plastic curette will be used to perform the mechanical debridement. Then, the addition photodynamic therapy (PDT) will be performed. This will be performed with a set-up for PDT (HELBO Photodynamic Systems, German).

Group Type: EXPERIMENTAL

Photodynamic therapy

Intervention Type: DEVICE

Photodynamic therapy (HELBO Photodynaimc Systems GmbH, Wels, Austria)

Mechanical debridement

Intervention Type: PROCEDURE

Plastic scalers (Have implantrecallset, Kerr, Italy) will be used to curette the contaminated sites.

Interventions

Photodynamic therapy

Photodynamic therapy (HELBO Photodynaimc Systems GmbH, Wels, Austria)

Intervention Type: DEVICE

Mechanical debridement

Plastic scalers (Have implantrecallset, Kerr, Italy) will be used to curette the contaminated sites.

Intervention Type: PROCEDURE

Irrigation

0.2% chlorhexidine digluconate solution (Bioworld, Madision, US) will be irrigated at contaminated sites for 1 minute.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male and female subjects, ages over 18.

2. Subjects with at least one implant with initial peri-implantitis: PPD of 4-6mm combined with BOP+, bone loss of 0.5-2mm on peri-apical radiographs compared to the time point of restoration placement.

3. Availability for the 12 month duration of the study.

4. Good general health (ASA classification I-II).

5. Signed Informed Consent Form.

Exclusion Criteria

1. Medically compromised subjects (ASA classification III-V)

2. Pregnant or lactating females.

3. Peri-implant mucositis defined as the absence of radiographic marginal bone loss between restoration placement and pre-screening review.

4. Subjects treated for >2 weeks with any medication known to affect soft tissue condition (e.g. phenytoin, calcium antagonists, cyclosporin, Coumadin and non-steroidal anti-inflammatory drugs) within 1 month of the baseline examination.

5. Unwilling to participate in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

OTHER

Sponsor Role: lead

Responsible Party

Junyu Shi

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Ninth People's Hospital

Shanghai, , China

Countries

China

Other Identifiers

1036_2016

Identifier Type: -

Identifier Source: org_study_id