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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title:

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.


Detailed Summary:
Sponsor: Shanghai 9th People's Hospital

Current Primary Outcome: Change of percentage of bleeding on probing sites [ Time Frame: From baseline to 12 months after treatment ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change of Probing Pocket Depth [ Time Frame: From baseline to 12 months after treatment ]
    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).
  • Change of modified plaque index [ Time Frame: From baseline to 12 months after treatment ]

    Modified plaque index 0= No detection of plaque.

    1. 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.
    2. Plaque can be seen by the naked eye.
    3. Abundance of soft matter.
  • Change of clinical attachment level [ Time Frame: From baseline to 12 months after treatment ]
  • Marginal bone loss [ Time Frame: From baseline to 12 months after treatment ]
    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.
  • Mucosa recession [ Time Frame: From baseline to 12 months after treatment ]
    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.


Original Secondary Outcome: Same as current

Information By: Shanghai 9th People's Hospital

Dates:
Date Received: July 21, 2016
Date Started: May 2017
Date Completion:
Last Updated: July 27, 2016
Last Verified: July 2016