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

Anti-infective Effect of Non-surgical Treatment With and Without Photodynamic

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.

Study Overview

• Status: Completed
• Conditions: Peri-implantitis
• Intervention / Treatment: Procedure: Mechanical debridement; Drug: Irrigation; Device: Photodynamic therapy

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 200011
    • Shanghai Ninth People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Plastic curette will be used to perform the mechanical debridement. Then, irrigation (2% chlorhexidine) will be performed at contaminated sites.	Procedure: Mechanical debridement; Plastic scalers (Have implantrecallset, Kerr, Italy) will be used to curette the contaminated sites.; Drug: Irrigation; 0.2% chlorhexidine digluconate solution (Bioworld, Madision, US) will be irrigated at contaminated sites for 1 minute.
Experimental: 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).	Procedure: Mechanical debridement; Plastic scalers (Have implantrecallset, Kerr, Italy) will be used to curette the contaminated sites.; Device: Photodynamic therapy; Photodynamic therapy (HELBO Photodynaimc Systems GmbH, Wels, Austria)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Probing Pocket Depth	Probing Pocket Depth at every site will be assessed as the distance from the gingival margin to the apical end of the pocket using a PQW Williams probe (Hu-Friedy, Chicago Ill, USA).	From baseline to 12 months after treatment
Change of modified plaque index	Modified plaque index 0= No detection of plaque.; Plaque only recognized by running a probe across the smooth marginal surface of the implant. Implants covered by titanium spray in this area always score 1.; Plaque can be seen by the naked eye.; Abundance of soft matter.	From baseline to 12 months after treatment
Change of clinical attachment level		From baseline to 12 months after treatment
Marginal bone loss	Periapical radiographs will be taken at baseline, 3, 6, 9 and 12 month examination. The distance from implant shoulder to the most coronal level of implant-bone contact at the mesial and distal site will be recorded. The alteration of the distance between baseline and follow-up visit will be defined as marginal bone loss.	From baseline to 12 months after treatment
Mucosa recession	The distance from mucosa margin to the implant shoulder will be recorded using a PQW Williams probe (Hu-Friedy, Chicago Ill, USA). The alteration of the distance between baseline and follow-up visit will be defined as the mucosa recession.	From baseline to 12 months after treatment

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2017
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 1, 2019

Study Registration Dates

• First Submitted: July 21, 2016
• First Submitted That Met QC Criteria: July 27, 2016
• First Posted (Estimate): July 28, 2016

Study Record Updates

• Last Update Posted (Actual): May 16, 2019
• Last Update Submitted That Met QC Criteria: May 14, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Photodynamic therapy
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis
• Other Study ID Numbers: 1036_2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No