ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT03100435
Recruitment Status : Recruiting
First Posted : April 4, 2017
Last Update Posted : January 11, 2018
Sponsor:
Information provided by (Responsible Party):
Tufts University School of Dental Medicine

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.


Condition or disease Intervention/treatment Phase
Peri-Implantitis Device: Er:YAG Laser Other: Carbon Fiber Curette Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Efficacy of Er:YAG Laser in Decontamination of Dental Implants: An In-Vitro Study
Actual Study Start Date : April 20, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
Experimental: Er:YAG Laser
Er:YAG Laser only
Device: Er:YAG Laser
Titanium disks will be decontaminated ex-vivo with the Er:YAG laser.

Active Comparator: Carbon Fiber Curette
Carbon fiber curette only
Other: Carbon Fiber Curette
Titanium disks will be decontaminated ex-vivo with carbon fiber curettes

Experimental: Er:YAG Laser + Carbon Fiber Curette
Combination of Er:YAG Laser and carbon fiber curette
Device: Er:YAG Laser
Titanium disks will be decontaminated ex-vivo with the Er:YAG laser.

Other: Carbon Fiber Curette
Titanium disks will be decontaminated ex-vivo with carbon fiber curettes

No Intervention: No Treatment
No treatment (control)



Primary Outcome Measures :
  1. Percent Bacteria Biofilm [ Time Frame: 3 days ]
    Percent area of the titanium disc covered by bacteria biofilm



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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): NCT03100435


Contacts
Contact: Amanda Gozzi 6176362147 Amanda.Gozzi@tufts.edu

Locations
United States, Massachusetts
Tufts University School of Dental Medicine Recruiting
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University School of Dental Medicine
Investigators
Principal Investigator: Robert Gyurko, DMD, PhD TUSDM

Responsible Party: Tufts University School of Dental Medicine
ClinicalTrials.gov Identifier: NCT03100435     History of Changes
Other Study ID Numbers: 12380
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: January 11, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Peri-Implantitis
Carbon fiber
Anti-Infective Agents, Local
Anti-Infective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents