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Efficacy of Er:YAG Laser in Decontamination of Dental Implants: An In-Vitro Study

Primary Purpose

Peri-Implantitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Er:YAG Laser
Carbon Fiber Curette
Sponsored by
Tufts University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peri-Implantitis

Eligibility Criteria

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

Inclusion Criteria:

  • Presence of enough teeth to support the mouth guard.
  • Subjects diagnosed with clinical health, gingivitis, or slight chronic periodontitis defined as periodontal inflammation with slight (1-2mm) attachment loss.

Exclusion Criteria:

  • Subjects with insufficient dental support for the mouth guard
  • Subjects diagnosed with moderate or severe chronic periodontitis.
  • Subjects with known allergy to acrylic or titanium.
  • Subjects who smoke cigarettes, cigars, snuff tobacco, or any other form of smoking.
  • Subjects with a history of antibiotic treatment within the last six months.
  • Subjects with contraindications to wearing a mouth guard, such as chronic obstructive pulmonary disease or severe sleep apnea.
  • Subjects with uncontrolled or debilitating medical conditions, including but not limited to subjects with uncontrolled diabetes, hematologic disorders, cancers, immunosuppression, severe cardiovascular disease, or uncontrolled thyroid disease
  • Subjects that are currently pregnant according to self-report

Sites / Locations

  • Tufts University School of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

No Intervention

Arm Label

Er:YAG Laser

Carbon Fiber Curette

Er:YAG Laser + Carbon Fiber Curette

No Treatment

Arm Description

Er:YAG Laser only

Carbon fiber curette only

Combination of Er:YAG Laser and carbon fiber curette

No treatment (control)

Outcomes

Primary Outcome Measures

Percent Bacteria Biofilm
Percent area of the titanium disc covered by bacteria biofilm

Secondary Outcome Measures

Full Information

First Posted
March 29, 2017
Last Updated
March 3, 2023
Sponsor
Tufts University
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1. Study Identification

Unique Protocol Identification Number
NCT03100435
Brief Title
Efficacy of Er:YAG Laser in Decontamination of Dental Implants: An In-Vitro Study
Official Title
Efficacy of Er:YAG Laser in Decontamination of Dental Implants: An In-Vitro Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
October 18, 2018 (Actual)
Study Completion Date
October 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peri-Implantitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Er:YAG Laser
Arm Type
Experimental
Arm Description
Er:YAG Laser only
Arm Title
Carbon Fiber Curette
Arm Type
Active Comparator
Arm Description
Carbon fiber curette only
Arm Title
Er:YAG Laser + Carbon Fiber Curette
Arm Type
Experimental
Arm Description
Combination of Er:YAG Laser and carbon fiber curette
Arm Title
No Treatment
Arm Type
No Intervention
Arm Description
No treatment (control)
Intervention Type
Device
Intervention Name(s)
Er:YAG Laser
Intervention Description
Titanium disks will be decontaminated ex-vivo with the Er:YAG laser.
Intervention Type
Other
Intervention Name(s)
Carbon Fiber Curette
Intervention Description
Titanium disks will be decontaminated ex-vivo with carbon fiber curettes
Primary Outcome Measure Information:
Title
Percent Bacteria Biofilm
Description
Percent area of the titanium disc covered by bacteria biofilm
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presence of enough teeth to support the mouth guard. Subjects diagnosed with clinical health, gingivitis, or slight chronic periodontitis defined as periodontal inflammation with slight (1-2mm) attachment loss. Exclusion Criteria: Subjects with insufficient dental support for the mouth guard Subjects diagnosed with moderate or severe chronic periodontitis. Subjects with known allergy to acrylic or titanium. Subjects who smoke cigarettes, cigars, snuff tobacco, or any other form of smoking. Subjects with a history of antibiotic treatment within the last six months. Subjects with contraindications to wearing a mouth guard, such as chronic obstructive pulmonary disease or severe sleep apnea. Subjects with uncontrolled or debilitating medical conditions, including but not limited to subjects with uncontrolled diabetes, hematologic disorders, cancers, immunosuppression, severe cardiovascular disease, or uncontrolled thyroid disease Subjects that are currently pregnant according to self-report
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Gyurko, DMD, PhD
Organizational Affiliation
TUSDM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts University School of Dental Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy of Er:YAG Laser in Decontamination of Dental Implants: An In-Vitro Study

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