Occurrence of Post-op Pain Following Gentlewave

NACompletedINTERVENTIONAL
Enrollment

87

Participants

Timeline

Start Date

September 1, 2018

Primary Completion Date

June 30, 2021

Study Completion Date

July 31, 2021

Conditions
Root Canal InfectionEndodontic DiseaseEndodontic InflammationPost-Operative Pain
Interventions
DEVICE

Gentlewave

The Gentlewave system from Sonendo is a FDA cleared root canal irrigation device that uses broad spectrum acoustic energy, internally degassed distilled water, 3% NaOCl, and 8% EDTA to allow for a more thorough cleaning within the tooth. The fluids work to remove necrotic tissue, debris, biofilm, and bacteria while leaving dentin intact and preserving tooth structure. The Gentlewave irrigation replaces the NaOCl ultrasonic activation and EDTA steps of the standard endodontic protocol. Use of the Gentlewave system is contraindicated in teeth with immature apices, teeth with insufficient coronal structure, and teeth with root apices extending into the maxillary sinus.

PROCEDURE

Standard Endodontic Protocol

The tooth will be sufficiently anesthetized with local anesthetic. The tooth will be rubber dam isolated. The pulp chamber will be accessed removing all caries, defective restorations, and defective crowns. EAL and radiographs will be used to determine the working length of each canal, all canals will be cleaned and shaped using rotary files to at least a size 25.04 canal size to within 0.5 to 1 mm of the apical terminus. Between each file 5.25% NaOCl will be used to disinfect and clear the canals of debris. A final passive ultrasonic activation of NaOCl will be done for 30 seconds per canal. Each canal will then soak in 17% EDTA for 1 minute, rinsed in 5.25% NaOCl, and finally undergo a final rinse of 95% ethanol. Canals will be obturated with root canal sealer and gutta-percha.

Trial Locations (1)

55455

University of Minnesota, School of Dentistry Department of Graduate Endodontics, Minneapolis

All Listed Sponsors
lead

University of Minnesota

OTHER

NCT03635515 - Occurrence of Post-op Pain Following Gentlewave | Biotech Hunter | Biotech Hunter