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

Primary Purpose

Peri-implantitis

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Photodynamic therapy
Mechanical debridement
Irrigation
Sponsored by
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Peri-implantitis focused on measuring Photodynamic therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Shanghai Ninth People's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Test group

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
Change of clinical attachment level
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.
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.

Full Information

First Posted
July 21, 2016
Last Updated
May 14, 2019
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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1. Study Identification

Unique Protocol Identification Number
NCT02848482
Brief Title
Anti-infective Effect of Non-surgical Treatment With and Without Photodynamic Therapy on Initial Peri-implantitis
Official Title
Anti-infective Effect of Non-surgical Treatment With and Without Photodynamic
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
May 1, 2019 (Actual)
Study Completion Date
May 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-implantitis
Keywords
Photodynamic therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Plastic curette will be used to perform the mechanical debridement. Then, irrigation (2% chlorhexidine) will be performed at contaminated sites.
Arm Title
Test group
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Photodynamic therapy
Intervention Description
Photodynamic therapy (HELBO Photodynaimc Systems GmbH, Wels, Austria)
Intervention Type
Procedure
Intervention Name(s)
Mechanical debridement
Intervention Description
Plastic scalers (Have implantrecallset, Kerr, Italy) will be used to curette the contaminated sites.
Intervention Type
Drug
Intervention Name(s)
Irrigation
Intervention Description
0.2% chlorhexidine digluconate solution (Bioworld, Madision, US) will be irrigated at contaminated sites for 1 minute.
Primary Outcome Measure Information:
Title
Change of percentage of bleeding on probing sites
Description
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.
Time Frame
From baseline to 12 months after treatment
Secondary Outcome Measure Information:
Title
Change of Probing Pocket Depth
Description
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).
Time Frame
From baseline to 12 months after treatment
Title
Change of modified plaque index
Description
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.
Time Frame
From baseline to 12 months after treatment
Title
Change of clinical attachment level
Time Frame
From baseline to 12 months after treatment
Title
Marginal bone loss
Description
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.
Time Frame
From baseline to 12 months after treatment
Title
Mucosa recession
Description
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.
Time Frame
From baseline to 12 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Shanghai Ninth People's Hospital
City
Shanghai
ZIP/Postal Code
200011
Country
China

12. IPD Sharing Statement

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

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