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Dental Infections

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Development Stage

Early Stage

Focused ultrasound research is in the laboratory phase and is not yet available for patients.

Clinical Trials

Focused ultrasound for this condition is being researched in clinical trials.

International Approval

Focused ultrasound is approved to treat this condition outside the US. Patients can seek commercial treatment at participating international sites.

FDA Approved

The US Food and Drug Administration has approved focus ultrasound for this condition. Patients can seek commercial treatment at participating sites.

Early Stage

Clinical Trials

International

FDA Approved

Focused ultrasound for this condition has been researched in clinical trials. However, at this time, we are not aware of any open clinical trials.

Focused Ultrasound Therapy

Focused ultrasound is a noninvasive, therapeutic technology with the potential to improve the quality of life and decrease the cost of care for patients with tooth disease that requires interventions. This includes a variety of types of procedures including root canals, restorations, implants, bridges or other procedures. The ability to disrupt infections and treat biofilms is an important part of a successful treatment.  

How it Works
This novel technology can work in a variety of ways, including sending beams of focused ultrasound energy into the cleaning fluid which forms cavitation bubbles. The negative pressure that comes from the cavitation greatly enhances the cleaning of the targeted tissue. This is very helpful as it is a noninvasive, non-ionizing, drug free method of treating dental hard tissues, bone disease, the root canal system and implants. This type of work is also being explored to help treat biofilms and more effectively deliver antibiotics.

Advantages
Conventional techniques effectively clean 29% of the nerve root, and passive ultrasound techniques may achieve 80%. The focused ultrasound cavitation bubble technique achieved a cleanliness level reported at greater than 97%. For certain patients, focused ultrasound use may improve the success of this procedure and also enhance the patient’s comfort.

Focused ultrasound also preserves dentin maintenance compared to mechanical techniques and easily accommodates the variable structure of the nerve root.

For more information, please see the patient information site or the manufacturer’s (Sonendo) website.

Clinical Trials

At the present time, there are no clinical trials recruiting patients. However, a 12-month study was completed recently. 

The Foundation updates these pages regularly, but with the increasing number of clinical trials, we want to be sure that our audience has the latest information available. Therefore, we also added the website search information for the above trials. If you click here, it will take you to the latest information available from https://www.clinicaltrials.gov/

Regulatory Approval and Reimbursement

This treatment is not yet approved by regulatory bodies or covered by medical insurance companies.

Notable Papers

Tran MD, Ngo H, Fawzy A. High-Intensity Focused Ultrasound in Dentistry: A Literature Review. Int Dent J. 2024 Apr 11:S0020-6539(24)00060-1. doi: 10.1016/j.identj.2024.02.004. PMID: 38609759 

Rajan SM, Shrestha B, Aati S, Kujan O, Tay A, Fawzy AS. Evaluation of Antibacterial Efficacy of High-Intensity Focused Ultrasound Versus Photodynamic Therapy Against Enterococcus faecalis-Infected Root Canals. Ultrasound Med Biol. 2023 Aug;49(8):1875-1881. doi: 10.1016/j.ultrasmedbio.2023.04.018. Epub 2023 May 30. PMID: 37263892 

Ordinola-Zapata R, Crepps JT, Arias A, Lin F. In vitro apical pressure created by 2 irrigation needles and a multisonic system in mandibular molars. Restor Dent Endod. 2021 Feb 8;46(1):e14. doi: 10.5395/rde.2021.46.e14. eCollection 2021 Feb.

Park SY, Kang MK, Choi HW, Shon WJ. Comparative Analysis of Root Canal Filling Debris and Smear Layer Removal Efficacy Using Various Root Canal Activation Systems during Endodontic Retreatment. Medicina (Kaunas). 2020 Nov 16;56(11):615. doi: 10.3390/medicina56110615.

Crozeta BM, Chaves de Souza L, Correa Silva-Sousa YT, Sousa-Neto MD, Jaramillo DE, Silva RM. Evaluation of Passive Ultrasonic Irrigation and GentleWave System as Adjuvants in Endodontic Retreatment. J Endod. 2020 Sep;46(9):1279-1285. doi: 10.1016/j.joen.2020.06.001. Epub 2020 Jun 15.

Grigsby D Jr, Ordinola-Zapata R, McClanahan SB, Fok A. Postoperative Pain after Treatment Using the GentleWave System: A Randomized Controlled Trial. J Endod. 2020 Aug;46(8):1017-1022. doi: 10.1016/j.joen.2020.04.004. Epub 2020 Jun 14.

Click here for additional references from PubMed.