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

NCT03100435 | Completed Results FDA Device

• 1 other identifier: 12380
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (1)

• Percent Bacteria Biofilm

  Percent area of the titanium disc covered by bacteria biofilm

  3 days

Study Arms (4)

Er:YAG Laser

EXPERIMENTAL

Er:YAG Laser only

Device: Er:YAG Laser

Carbon Fiber Curette

ACTIVE COMPARATOR

Carbon fiber curette only

Other: Carbon Fiber Curette

Er:YAG Laser + Carbon Fiber Curette

EXPERIMENTAL

Combination of Er:YAG Laser and carbon fiber curette

Device: Er:YAG Laser; Other: Carbon Fiber Curette

No Treatment

NO INTERVENTION

No treatment (control)

Interventions

Er:YAG Laser DEVICE

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

Er:YAG Laser; Er:YAG Laser + Carbon Fiber Curette

Carbon Fiber Curette OTHER

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

Carbon Fiber Curette; Er:YAG Laser + Carbon Fiber Curette

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Peri-Implantitis

Interventions

Lasers, Solid-State

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Results Point of Contact

• Title: Robert Gyurko
• Organization: Tufts University

robert.gyurko@tufts.edu

6176366531

Study Officials

• Robert Gyurko, DMD, PhD

  TUSDM

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 4, 2017
• Study Start: April 20, 2017
• Primary Completion: October 18, 2018
• Study Completion: October 18, 2018
• Last Updated: March 31, 2023
• Results First Posted: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)