NCT03100435

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

Completed NA Results posted Last updated 31 March 2023

What this trial tests

NA trial testing Er:YAG Laser in Peri-Implantitis in 8 participants. Completed in 18 October 2018.

Timeline

20 April 2017

Primary endpoint
18 October 2018

18 October 2018

Quick facts

Lead sponsor	Tufts University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	8
Start date	20 April 2017
Primary completion	18 October 2018
Estimated completion	18 October 2018
Sites	1 location across United States

Drugs / interventions tested

• Er:YAG Laser
• Carbon Fiber Curette

Conditions studied

• Peri-Implantitis — all drugs for Peri-Implantitis →

Sponsor

Tufts University

Who can join

18 and older, any sex, with Peri-Implantitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Bacteria Biofilm Primary · 3 days

Percent area of the titanium disc covered by bacteria biofilm

Group	Value	95% CI
Laser	32.78	± 24
Curette	20.14	± 19.15
Brush	11.8	± 10.29
Control	74.03	± 21.61

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 days (the duration of wearing the intraoral appliance). Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Er:YAG Laser

Serious: 0/8 (0%)

Deaths: 0/8

Carbon Fiber Curette

Serious: 0/8 (0%)

Deaths: 0/8

Er:YAG Laser + Carbon Fiber Curette

Serious: 0/8 (0%)

Deaths: 0/8

No Treatment

Serious: 0/8 (0%)

Deaths: 0/8

Other adverse events (1 terms — click to expand)

Reaction	System	Er:YAG Laser	Carbon Fiber Curette	Er:YAG Laser + Carbon Fibe…	No Treatment
Titanium disc dislodged from appliance	Product Issues	—	—	—	—

Data from ClinicalTrials.gov NCT03100435 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.