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

NCT ID: NCT03100435

Last Updated: 2023-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-20
• Study Completion Date: 2018-10-18

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.

Conditions

Peri-Implantitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Er:YAG Laser

Er:YAG Laser only

Group Type: EXPERIMENTAL

Er:YAG Laser

Intervention Type: DEVICE

Titanium disks will be decontaminated ex-vivo with the Er:YAG laser.

Carbon Fiber Curette

Carbon fiber curette only

Group Type: ACTIVE_COMPARATOR

Carbon Fiber Curette

Intervention Type: OTHER

Titanium disks will be decontaminated ex-vivo with carbon fiber curettes

Er:YAG Laser + Carbon Fiber Curette

Combination of Er:YAG Laser and carbon fiber curette

Group Type: EXPERIMENTAL

Er:YAG Laser

Intervention Type: DEVICE

Titanium disks will be decontaminated ex-vivo with the Er:YAG laser.

Carbon Fiber Curette

Intervention Type: OTHER

Titanium disks will be decontaminated ex-vivo with carbon fiber curettes

No Treatment

No treatment (control)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Er:YAG Laser

Titanium disks will be decontaminated ex-vivo with the Er:YAG laser.

Intervention Type: DEVICE

Carbon Fiber Curette

Titanium disks will be decontaminated ex-vivo with carbon fiber curettes

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Robert Gyurko, DMD, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Gyurko, DMD, PhD

Role: PRINCIPAL_INVESTIGATOR

TUSDM

Locations

Tufts University School of Dental Medicine

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

12380

Identifier Type: -

Identifier Source: org_study_id