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

NCT02848482 | Completed Phase 3

• 1 other identifier: 1036_2016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Photodynamic therapy

Outcome Measures

Primary Outcomes (1)

• Change of percentage of bleeding on probing sites

  A PQW Williams probe (Hu-Friedy, Chicago Ill, USA)will be used to detect the peri-implant pocket. the percentage of bleeding on probing sites (BOP) will be recorded.

  From baseline to 12 months after treatment

Secondary Outcomes (5)

• Change of Probing Pocket Depth

  From baseline to 12 months after treatment

• Change of modified plaque index

  From baseline to 12 months after treatment

• Change of clinical attachment level

  From baseline to 12 months after treatment

• Marginal bone loss

  From baseline to 12 months after treatment

• Mucosa recession

  From baseline to 12 months after treatment

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Procedure: Mechanical debridement; Drug: Irrigation

Test group

EXPERIMENTAL

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).

Device: Photodynamic therapy; Procedure: Mechanical debridement

Interventions

Photodynamic therapy DEVICE

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

Test group

Mechanical debridement PROCEDURE

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

Control group; Test group

Irrigation DRUG

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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects, ages over 18.
• 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.
• Availability for the 12 month duration of the study.
• Good general health (ASA classification I-II).
• Signed Informed Consent Form.

You may not qualify if:

• Medically compromised subjects (ASA classification III-V)
• Pregnant or lactating females.
• Peri-implant mucositis defined as the absence of radiographic marginal bone loss between restoration placement and pre-screening review.
• 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.
• Unwilling to participate in the study.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (1)

Shanghai Ninth People's Hospital

Shanghai, 200011, China

Location

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Photochemotherapy; Therapeutic Irrigation

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Hydrotherapy; Physical Therapy Modalities; Rehabilitation; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: July 28, 2016
• Study Start: May 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: May 16, 2019

Record last verified: 2019-05

Locations

CN (1)