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

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ClinicalTrials.gov Identifier: NCT02848482
Recruitment Status : Completed
First Posted : July 28, 2016
Last Update Posted : May 16, 2019
Sponsor:
Information provided by (Responsible Party):
Junyu Shi, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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.


Condition or disease Intervention/treatment Phase
Peri-implantitis Device: Photodynamic therapy Procedure: Mechanical debridement Drug: Irrigation Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Anti-infective Effect of Non-surgical Treatment With and Without Photodynamic
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : May 1, 2019
Actual Study Completion Date : May 1, 2019

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).
Device: Photodynamic therapy
Photodynamic therapy (HELBO Photodynaimc Systems GmbH, Wels, Austria)

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.

    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.

  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848482


Locations
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China
Shanghai Ninth People's Hospital
Shanghai, China, 200011
Sponsors and Collaborators
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

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Responsible Party: Junyu Shi, Dr., Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT02848482     History of Changes
Other Study ID Numbers: 1036_2016
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Junyu Shi, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University:
Photodynamic therapy
Additional relevant MeSH terms:
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Peri-Implantitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Infective Agents