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Clinical and Microbiologic Outcomes of aPDT in the Non-surgical Treatment of Implant Inflammation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04187053
Recruitment Status : Not yet recruiting
First Posted : December 5, 2019
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
Marcos E Garcia, The University of Texas Health Science Center, Houston

Brief Summary:
The purpose of this study is to compare clinical outcomes (change in bleeding sites (BOP) and probing depth reduction (PPD) after mechanical debridement of implant surfaces at sites exhibiting plaque induced inflammation with or without adjunctive antimicrobial photodynamic therapy (aPDT) and assess the microbiologic profile of plaque samples before and after treatment with or without aPDT. samples.

Condition or disease Intervention/treatment Phase
DENT IMPLANTS LASER Procedure: Conventional mechanical therapy Drug: Saline Drug: Methylene Blue Device: Light emitting laser Device: Non-light emitting laser Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical and Microbiologic Outcomes of Adjunctive Antimicrobial Photodynamic Therapy in the Non-surgical Treatment of Peri-implant Disease
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : August 1, 2020

Arm Intervention/treatment
Experimental: Conventional mechanical therapy with aPDT adjunct
Traditional non-surgical mechanical debridement along with antimicrobial photodynamic therapy will be done at implant sites by applying a photosensitizing dye methylene blue (0.1mg/ml) with a disposable syringe from the bottom of pocket in a coronal direction. The dye will be applied topically confined to the epithelialized space surrounding the implant fixture and will not be internalized. After 5 minutes in situ, the surrounding gingival tissues will be irradiated at six sites around the implant using a diode laser with a wavelength of 660nm, providing an energy density of 10 J/site, 100mW power, time equal to 100 seconds. After irradiation, the site will be thoroughly rinsed with saline.
Procedure: Conventional mechanical therapy
Both experimental and sham arms will receive the Conventional mechanical therapy

Drug: Methylene Blue
Experimental arm will receive methylene blue

Device: Light emitting laser
Experimental arm will receive Light emitting laser

Sham Comparator: Conventional mechanical therapy with sham aPDT treatment
Control group will have conventional mechanical instrumentation of implant site with "Sham" aPDT treatment with saline and non-light emitting laser
Procedure: Conventional mechanical therapy
Both experimental and sham arms will receive the Conventional mechanical therapy

Drug: Saline
Sham group will receive saline as a sham for methylene blue

Device: Non-light emitting laser
Sham group will receive Non-light emitting laser




Primary Outcome Measures :
  1. Improvement in sites as indicated by reduction in inflammation as assessed by pocket depth [ Time Frame: Baseline ]
  2. Improvement in sites as indicated by reduction in inflammation as assessed by pocket depth [ Time Frame: 6 weeks post treatment ]
  3. Improvement in sites as indicated by reduction in inflammation as assessed by pocket depth [ Time Frame: 12 weeks post treatment ]
  4. Improvement in sites as indicated by reduction in inflammation as assessed by clinical attachment loss [ Time Frame: Baseline ]
  5. Improvement in sites as indicated by reduction in inflammation as assessed by clinical attachment loss [ Time Frame: 6 weeks post treatment ]
  6. Improvement in sites as indicated by reduction in inflammation as assessed by clinical attachment loss [ Time Frame: 12 weeks post treatment ]
  7. Improvement in sites as indicated by reduction in inflammation as assessed by bleeding on probing [ Time Frame: Baseline ]
  8. Improvement in sites as indicated by reduction in inflammation as assessed by bleeding on probing [ Time Frame: 6 weeks post treatment ]
  9. Improvement in sites as indicated by reduction in inflammation as assessed by bleeding on probing [ Time Frame: 12 weeks post treatment ]
  10. Improvement in sites as indicated by reduction in inflammation as assessed by presence of plaque [ Time Frame: Baseline ]
  11. Improvement in sites as indicated by reduction in inflammation as assessed by presence of plaque [ Time Frame: 6 weeks post treatment ]
  12. Improvement in sites as indicated by reduction in inflammation as assessed by presence of plaque [ Time Frame: 12 weeks post treatment ]

Secondary Outcome Measures :
  1. Assessment of 16S rRNA gene data from plaque samples [ Time Frame: Baseline ]
    Plaque samples will be taken from the deepest probing site of each implant at baseline and 12 weeks after aPDT. Bacterial analysis through 16S rRNA gene V4 amplification and sequencing. 16S rRNA gene data will then be analyzed assessing for a change in microbiota community associated with a healthy implant site.

  2. Assessment of 16S rRNA gene data from plaque samples [ Time Frame: 12 weeks post treatment ]
    Plaque samples will be taken from the deepest probing site of each implant at baseline and 12 weeks after aPDT. Bacterial analysis through 16S rRNA gene V4 amplification and sequencing. 16S rRNA gene data will then be analyzed assessing for a change in microbiota community associated with a healthy implant site.



Information from the National Library of Medicine

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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:

  • at least one implant with peri-implant inflammation that requires non-surgical treatment.
  • Peri-implant diseases included are peri-implant mucositis and peri-implantitis

Criteria for diagnosis of peri-implant mucositis or peri-implantitis:

  1. Red, swollen gingival tissues surrounding the implant
  2. Presence of bleeding and/or suppuration on gentle probing around the implant
  3. Increased probing depth compared to probing depth after restoration of the implant (greater than 2mm increase in probing depth)
  4. May or may not have progressive bone loss in relation to radiographic bone levels assessed either 1 year following restoration of the implant OR ≥3mm of radiographic bone loss from the implant platform -systemically healthy or with controlled common systemic conditions, such as hypertension, that will not affect wound healing.

Exclusion Criteria:

  • current heavy smokers (>10 cigarettes/day)
  • have diabetes or other systemic diseases that may comprise healing
  • take antibiotics within 3 months before the procedure

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): NCT04187053


Contacts
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Contact: Marcos E. Garcia, DDS 713-486-4048 Marcos.E.Garcia@uth.tmc.edu
Contact: Juliana A. Barros, DDS, MS 713-486-4564 Juliana.Barros@uth.tmc.edu

Locations
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United States, Texas
University of Texas Health Science Center at Houston School of Dentistry
Houston, Texas, United States, 77030
Contact: Marcos E. Garcia, DDS    713-486-4048    marcos.e.garcia@uth.tmc.edu   
Contact: Juliana A. Barros, DDS, MS    713-486-4564    Juliana.Barros@uth.tmc.edu   
Principal Investigator: Marcos Garcia, DDS         
Sub-Investigator: Gabriella Diaz, DDS         
Sub-Investigator: Sridhar Eswaran, BDS, MS, MSD         
Sub-Investigator: Jennifer Chang, DDS, MSD         
Sub-Investigator: Juliana Barros, DDS, MS         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Marcos E Garcia, DDS The University of Texas Health Science Center, Houston
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Responsible Party: Marcos E Garcia, Periodontics Resident, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT04187053    
Other Study ID Numbers: HSC-DB-19-0873
First Posted: December 5, 2019    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Marcos E Garcia, The University of Texas Health Science Center, Houston:
Dental implants
Laser
Antimicrobial photodynamic therapy
Low level laser therapy
Peri-implant mucositis
Peri-implantitis
Additional relevant MeSH terms:
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Methylene Blue
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action