Skip to main content
OpenTrials
Completed

NCT Number: NCT02848482

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shanghai Ninth People's Hospital

Shanghai, 200011, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Photodynamic therapy

Device

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

Mechanical debridement

Procedure

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

Irrigation

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. Change of modified plaque index

    Time frame: From baseline to 12 months after treatment

    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.

  3. Change of clinical attachment level

    Time frame: From baseline to 12 months after treatment

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 28, 2016
Registry last updated
May 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.