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The American Association of Oral and Maxillofacial Surgeons estimated that 69% of adults ages 35 to 44 have lost at least one permanent tooth. Dental implants have revolutionized dentistry by providing tooth-like replacement for missing teeth and a solution that is predictable with long-term success..
After the implant is placed, natural bacteria from the mouth can develop around implants just like around natural teeth. Studies have shown that bacterial contamination can cause peri-implantitis- gum disease or inflammation around the implant, eventually leading to bone loss. Removing bacteria from dental implant surfaces can prevent peri-implantitis, and surface debridement constitutes the basis of treatment of peri-implant disease.
Typically, mechanical hand instrumentation using curettes to remove biofilm and calculus is the main basis for periodontal therapy. However, total debridement is difficult, and the hand tools may damage the surface of the implant and making it more plaque retentive. Studies have shown that mechanical non-surgical therapy alone is not sufficient to treat peri-implantitis.
There is evidence that a dental laser may be an effective method to remove bacteria from implant surfaces, with less damage to the surface. One type of dental laser, Er:YAG, appears optimal for implant decontamination as the Er:YAG laser energy is primarily absorbed by water, resulting in vaporization of bacteria and minimal surface alterations on the implant surface.The aim of this study is to evaluate the efficiency of biofilm decontamination of Er:YAG laser compared to carbon fiber curette.
The aim of this study is to compare the amount of residual biofilm on titanium discs after decontamination with Er:YAG laser and carbon fiber curette.
In the first phase of the study, custom mouth guards that holds multiple titanium discs will be fabricated. Experimental subjects will be instructed to wear this mouth guard for 72 hours, during which time a natural bacterial biofilm will form on the disc surfaces.
The second phase of the study will be performed ex vivo after collecting the discs from the subjects. Discs retrieved from each mouth guard will be randomized over the 4 treatment groups, so that each subject will contribute two discs to each treatment group: 1) Er:YAG laser, 2) carbon fiber curette, 3) combination of carbon fiber curette and Er:YAG laser, and 4) no treatment (control). The biofilm will be stained and the residual biofilm will be visualized under fluorescence microscopy. Statistical methods will be used to determine the significance of each treatment modality.
The primary outcome of the study is the percent area of the titanium disc covered by biofilm.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Er:YAG Laser | Experimental | Er:YAG Laser only |
|
| Carbon Fiber Curette | Active Comparator | Carbon fiber curette only |
|
| Er:YAG Laser + Carbon Fiber Curette | Experimental | Combination of Er:YAG Laser and carbon fiber curette |
|
| No Treatment | No Intervention | No treatment (control) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Er:YAG Laser | Device | Titanium disks will be decontaminated ex-vivo with the Er:YAG laser. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Bacteria Biofilm | Percent area of the titanium disc covered by bacteria biofilm | 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Gyurko, DMD, PhD | TUSDM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts University School of Dental Medicine | Boston | Massachusetts | 02111 | United States |
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Each subject participates in each arm, as 2 titanium discs from each subject are distributed among all 4 arms.
From May 2017 to August 2018, 8 enrollments were made in the Department of Periodontology at Tufts University School of Dental Medicine
| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | Each participant provides 2 Titanium disks that are decontaminated ex-vivo with the Er:YAG laser, with carbon fiber curette, with titanium brush, or not decontaminated. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Each participant contributes 2 titanium discs to each arm therefore creating 64 discs to analyze across 4 arms.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Titanium disks are decontaminated ex-vivo with the Er:YAG laser, with carbon fiber curettes, with titanium brush, or are not decontaminated . |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Bacteria Biofilm | Percent area of the titanium disc covered by bacteria biofilm | From 64 collected titanium disks, 5 were removed from analysis. 4 disks were dislodged from 2 enrolled participants and 1 disk was excluded due to improper magnification of the SYTO 9 imaging. | Posted | Mean | Standard Deviation | percentage of disc covered | 3 days | Titanium disks | Titanium disks |
|
3 days (the duration of wearing the intraoral appliance)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Er:YAG Laser | Er:YAG Laser only Er:YAG Laser: Titanium disks will be decontaminated ex-vivo with the Er:YAG laser. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Titanium disc dislodged from appliance | Product Issues | Non-systematic Assessment | Titanium discs were dislodged from the appliance in 2 of the 8 participants. Dislodged discs were excluded from the analysis. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Gyurko | Tufts University | 6176366531 | robert.gyurko@tufts.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 10, 2017 | Feb 24, 2023 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D057873 | Peri-Implantitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
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All participants will wear a mouth guard holding 8 titanium discs for 3 days, during which time a natural bacterial biofilm will form on the disc surfaces. After 3 days, the discs will be removed from the mouthguard, and treated ex vivo with different decontamination methods.
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| Carbon Fiber Curette | Other | Titanium disks will be decontaminated ex-vivo with carbon fiber curettes |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| Brush |
Titanium disks are decontaminated ex-vivo with titanium brush |
| OG003 | Control | Titanium disks are not decontaminated |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 2 |
| 8 |
| EG001 | Carbon Fiber Curette | Carbon fiber curette only Carbon Fiber Curette: Titanium disks will be decontaminated ex-vivo with carbon fiber curettes | 0 | 8 | 0 | 8 | 2 | 8 |
| EG002 | Er:YAG Laser + Carbon Fiber Curette | Combination of Er:YAG Laser and carbon fiber curette Er:YAG Laser: Titanium disks will be decontaminated ex-vivo with the Er:YAG laser. Carbon Fiber Curette: Titanium disks will be decontaminated ex-vivo with carbon fiber curettes | 0 | 8 | 0 | 8 | 2 | 8 |
| EG003 | No Treatment | No treatment (control) | 0 | 8 | 0 | 8 | 2 | 8 |
|
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