Sonendo GentleWave™ System for Treatment in Molar Teeth Requiring Root Canal Therapy

Root Canal Therapy Clinical Trial

— SUPREME  

Official title:

A Prospective, Multicenter Study Comparing Healing After Treatment With the Sonendo GentleWave™ System as Compared to a Traditional Root Canal Therapy Literature Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02285595
• Other study ID #: CS-06
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: December 31, 2018

Study information

• Verified date: January 2023
• Source: Sonendo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A prospective, literature controlled, clinical study evaluating healing rates for the Sonendo GentleWave System in the treatment of 1st and 2nd molars indicated for root canal therapy.

Description:

A prospective, non-significant risk device, literature controlled, study evaluating healing rates for the Sonendo GentleWave System in the treatment of 1st and 2nd molars indicated for root canal therapy.

All patients will receive root canal therapy with the Sonendo GentleWave System. All patients will be followed for 24 months post procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: December 31, 2018
• Est. primary completion date: June 22, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 18 to 75 years of age

• Indicated for root canal therapy

• First or second molar

• Signed informed consent form

Exclusion Criteria:

• Poor oral hygiene

• Class II or III mobility

• Open or incompletely formed root apices

• Vertical fracture, horizontal fracture, or perforation below the Cemento-Enamel Junction (CEJ)

• Previous pulpectomy or root canal therapy

Note: Additional exclusion criteria may apply.

Related Conditions & MeSH terms

• Root Canal Therapy

Intervention

Device:
• Sonendo GentleWave™ System

Locations

Country	Name	City	State
United States	Shahriar Rassoulian, DMD	Aliso Viejo	California
United States	Khang Le, DDS	Santa Ana	California
United States	Stacey Woo, DDS	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Sonendo, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (68)

al-Omari MA, Dummer PM. Canal blockage and debris extrusion with eight preparation techniques. J Endod. 1995 Mar;21(3):154-8. doi: 10.1016/s0099-2399(06)80443-7. — View Citation

Alhadainy HA. Root perforations. A review of literature. Oral Surg Oral Med Oral Pathol. 1994 Sep;78(3):368-74. doi: 10.1016/0030-4220(94)90070-1. — View Citation

Azar NG, Ebrahimi G. Apically-extruded debris using the ProTaper system. Aust Endod J. 2005 Apr;31(1):21-3. doi: 10.1111/j.1747-4477.2005.tb00202.x. — View Citation

Balto H., Al-Nazhan S. s.l, Accidental injection of sodium hypochlorite beyond the root apex: Saudi Dent. J., 2002, Vol. 14.

Becker GL, Cohen S, Borer R. The sequelae of accidentally injecting sodium hypochlorite beyond the root apex. Report of a case. Oral Surg Oral Med Oral Pathol. 1974 Oct;38(4):633-8. doi: 10.1016/0030-4220(74)90097-8. No abstract available. — View Citation

Becking AG. Complications in the use of sodium hypochlorite during endodontic treatment. Report of three cases. Oral Surg Oral Med Oral Pathol. 1991 Mar;71(3):346-8. doi: 10.1016/0030-4220(91)90313-2. — View Citation

Bergenholtz G, Lekholm U, Milthon R, Heden G, Odesjo B, Engstrom B. Retreatment of endodontic fillings. Scand J Dent Res. 1979 Jun;87(3):217-24. doi: 10.1111/j.1600-0722.1979.tb00675.x. — View Citation

Berman L. H., Hartwell, G. R. "Diagnosis", in Pathways of the Pulp, ed. S. Cohen, K. Hargreaves, 9th ed. St. Louis: Mosby, 2006.

Bowden JR, Ethunandan M, Brennan PA. Life-threatening airway obstruction secondary to hypochlorite extrusion during root canal treatment. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):402-4. doi: 10.1016/j.tripleo.2005.06.021. Epub 2005 Oct 5. No abstract available. — View Citation

Cohen S., Burns R. C. Pathways of the pulp. 8th ed. St Louis: Mosby, 2002.

Cymbler DM, Ardakani P. Sodium hypochlorite injection into periapical tissues. Dent Update. 1994 Oct;21(8):345-6. — View Citation

de Sermeno RF, da Silva LA, Herrera H, Herrera H, Silva RA, Leonardo MR. Tissue damage after sodium hypochlorite extrusion during root canal treatment. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2009 Jul;108(1):e46-9. doi: 10.1016/j.tripleo.2008.12.024. Epub 2009 May 13. — View Citation

Ehrich DG, Brian JD Jr, Walker WA. Sodium hypochlorite accident: inadvertent injection into the maxillary sinus. J Endod. 1993 Apr;19(4):180-2. doi: 10.1016/S0099-2399(06)80684-9. — View Citation

ElAyouti A, Dima E, Ohmer J, Sperl K, von Ohle C, Lost C. Consistency of apex locator function: a clinical study. J Endod. 2009 Feb;35(2):179-81. doi: 10.1016/j.joen.2008.10.017. Epub 2008 Dec 12. — View Citation

ElAyouti A, Weiger R, Lost C. Frequency of overinstrumentation with an acceptable radiographic working length. J Endod. 2001 Jan;27(1):49-52. doi: 10.1097/00004770-200101000-00018. — View Citation

Eleftheriadis GI, Lambrianidis TP. Technical quality of root canal treatment and detection of iatrogenic errors in an undergraduate dental clinic. Int Endod J. 2005 Oct;38(10):725-34. doi: 10.1111/j.1365-2591.2005.01008.x. — View Citation

Ferraz CC, Gomes NV, Gomes BP, Zaia AA, Teixeira FB, Souza-Filho FJ. Apical extrusion of debris and irrigants using two hand and three engine-driven instrumentation techniques. Int Endod J. 2001 Jul;34(5):354-8. doi: 10.1046/j.1365-2591.2001.00394.x. — View Citation

Friedman S, Lost C, Zarrabian M, Trope M. Evaluation of success and failure after endodontic therapy using a glass ionomer cement sealer. J Endod. 1995 Jul;21(7):384-90. doi: 10.1016/S0099-2399(06)80976-3. — View Citation

Gatot A, Arbelle J, Leiberman A, Yanai-Inbar I. Effects of sodium hypochlorite on soft tissues after its inadvertent injection beyond the root apex. J Endod. 1991 Nov;17(11):573-4. doi: 10.1016/S0099-2399(06)81725-5. — View Citation

Glickman GN. AAE Consensus Conference on Diagnostic Terminology: background and perspectives. J Endod. 2009 Dec;35(12):1619-20. doi: 10.1016/j.joen.2009.09.029. No abstract available. — View Citation

Gracely RH, Kwilosz DM. The Descriptor Differential Scale: applying psychophysical principles to clinical pain assessment. Pain. 1988 Dec;35(3):279-288. doi: 10.1016/0304-3959(88)90138-8. — View Citation

Greene KJ, Krell KV. Clinical factors associated with ledged canals in maxillary and mandibular molars. Oral Surg Oral Med Oral Pathol. 1990 Oct;70(4):490-7. doi: 10.1016/0030-4220(90)90217-g. — View Citation

Gutmann J. L., Dumsha T. C., Lovdahl P. E., Hovland E. J. Problem Solving in Endodontics (3rd ed.). St. Louis: Mosby, 1997.

Harpenau, L. A. "Furcation Involvement", in Hall's Critical Decisions in Periodontology, ed. Harpenau, L. A. Shelton, CT: People's Medical Publishing House, 2013.

Harty FJ, Parkins BJ, Wengraf AM. Success rate in root canal therapy. A retrospective study of conventional cases. Br Dent J. 1970 Jan 20;128(2):65-70. doi: 10.1038/sj.bdj.4802429. No abstract available. — View Citation

Herrmann JW, Heicht RC. Complications in therapeutic use of sodium hypochlorite. J Endod. 1979 May;5(5):160. doi: 10.1016/S0099-2399(79)80039-4. No abstract available. — View Citation

Hulsmann M, Hahn W. Complications during root canal irrigation--literature review and case reports. Int Endod J. 2000 May;33(3):186-93. doi: 10.1046/j.1365-2591.2000.00303.x. — View Citation

Hulsmann M, Schade M, Schafers F. A comparative study of root canal preparation with HERO 642 and Quantec SC rotary Ni-Ti instruments. Int Endod J. 2001 Oct;34(7):538-46. doi: 10.1046/j.1365-2591.2001.00431.x. — View Citation

Ingle J. I., Bakland L. K. Endodontics. 5th ed. London: BC Decker Inc., 2002.

Jafarzadeh H, Abbott PV. Ledge formation: review of a great challenge in endodontics. J Endod. 2007 Oct;33(10):1155-62. doi: 10.1016/j.joen.2007.07.015. Epub 2007 Sep 4. — View Citation

Jew RC, Weine FS, Keene JJ Jr, Smulson MH. A histologic evaluation of periodontal tissues adjacent to root perforations filled with Cavit. Oral Surg Oral Med Oral Pathol. 1982 Jul;54(1):124-35. doi: 10.1016/0030-4220(82)90427-3. — View Citation

Joffe E. Complication during root canal therapy following accidental extrusion of sodium hypochlorite through the apical foramen. Gen Dent. 1991 Nov-Dec;39(6):460-1. No abstract available. — View Citation

Kapalas A, Lambrianidis T. Factors associated with root canal ledging during instrumentation. Endod Dent Traumatol. 2000 Oct;16(5):229-31. doi: 10.1034/j.1600-9657.2000.016005229.x. — View Citation

Kavanagh CP, Taylor J. Inadvertent injection of sodium hypochlorite into the maxillary sinus. Br Dent J. 1998 Oct 10;185(7):336-7. doi: 10.1038/sj.bdj.4809809. — View Citation

Koseoglu BG, Tanrikulu S, Subay RK, Sencer S. Anesthesia following overfilling of a root canal sealer into the mandibular canal: a case report. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Jun;101(6):803-6. doi: 10.1016/j.tripleo.2005.07.015. Epub 2006 Jan 4. — View Citation

Kustarci A, Akpinar KE, Er K. Apical extrusion of intracanal debris and irrigant following use of various instrumentation techniques. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2008 Feb;105(2):257-62. doi: 10.1016/j.tripleo.2007.06.028. — View Citation

Logani A, Shah N. Apically extruded debris with three contemporary Ni-Ti instrumentation systems: an ex vivo comparative study. Indian J Dent Res. 2008 Jul-Sep;19(3):182-5. doi: 10.4103/0970-9290.42947. — View Citation

Louis H. Berman and Gary R. Hartwell. "Diagnosis", in pathways of the Pulp, K. Hargreaves, S. Cohen, 10th ed. St. Louis: Mosby, 2011.

Martin H, Cunningham WT. The effect of endosonic and hand manipulation on the amount of root canal material extruded. Oral Surg Oral Med Oral Pathol. 1982 Jun;53(6):611-3. doi: 10.1016/0030-4220(82)90350-4. No abstract available. — View Citation

McGurkin-Smith R, Trope M, Caplan D, Sigurdsson A. Reduction of intracanal bacteria using GT rotary instrumentation, 5.25% NaOCl, EDTA, and Ca(OH)2. J Endod. 2005 May;31(5):359-63. doi: 10.1097/01.don.0000145035.85272.7c. — View Citation

Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8. — View Citation

Naidorf IJ. Endodontic flare-ups: bacteriological and immunological mechanisms. J Endod. 1985 Nov;11(11):462-4. doi: 10.1016/S0099-2399(85)80218-1. No abstract available. — View Citation

Namazikhah MS, Mokhlis HR, Alasmakh K. Comparison between a hand stainless-steel K file and a rotary NiTi 0.04 taper. J Calif Dent Assoc. 2000 Jun;28(6):421-6. — View Citation

Orstavik D, Kerekes K, Eriksen HM. The periapical index: a scoring system for radiographic assessment of apical periodontitis. Endod Dent Traumatol. 1986 Feb;2(1):20-34. doi: 10.1111/j.1600-9657.1986.tb00119.x. No abstract available. — View Citation

Parashos P, Gordon I, Messer HH. Factors influencing defects of rotary nickel-titanium endodontic instruments after clinical use. J Endod. 2004 Oct;30(10):722-5. doi: 10.1097/01.don.0000129963.42882.c9. — View Citation

Parashos P, Messer HH. Rotary NiTi instrument fracture and its consequences. J Endod. 2006 Nov;32(11):1031-43. doi: 10.1016/j.joen.2006.06.008. — View Citation

Peters OA, Peters CI, Schonenberger K, Barbakow F. ProTaper rotary root canal preparation: effects of canal anatomy on final shape analysed by micro CT. Int Endod J. 2003 Feb;36(2):86-92. doi: 10.1046/j.1365-2591.2003.00626.x. — View Citation

Peters OA, Schonenberger K, Laib A. Effects of four Ni-Ti preparation techniques on root canal geometry assessed by micro computed tomography. Int Endod J. 2001 Apr;34(3):221-30. doi: 10.1046/j.1365-2591.2001.00373.x. — View Citation

Reddy SA, Hicks ML. Apical extrusion of debris using two hand and two rotary instrumentation techniques. J Endod. 1998 Mar;24(3):180-3. doi: 10.1016/S0099-2399(98)80179-9. — View Citation

Salzgeber RM, Brilliant JD. An in vivo evaluation of the penetration of an irrigating solution in root canals. J Endod. 1977 Oct;3(10):394-8. doi: 10.1016/S0099-2399(77)80172-6. No abstract available. — View Citation

Sari S, Duruturk L. Radiographic evaluation of periapical healing of permanent teeth with periapical lesions after extrusion of AH Plus sealer. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Sep;104(3):e54-9. doi: 10.1016/j.tripleo.2007.03.024. — View Citation

Seltzer S, Bender IB, Smith J, Freedman I, Nazimov H. Endodontic failures--an analysis based on clinical, roentgenographic, and histologic findings. I. Oral Surg Oral Med Oral Pathol. 1967 Apr;23(4):500-16. doi: 10.1016/0030-4220(67)90546-4. No abstract available. — View Citation

Seltzer S, Naidorf IJ. Flare-ups in endodontics: I. Etiological factors. J Endod. 1985 Nov;11(11):472-8. doi: 10.1016/S0099-2399(85)80220-X. No abstract available. — View Citation

Shuping GB, Orstavik D, Sigurdsson A, Trope M. Reduction of intracanal bacteria using nickel-titanium rotary instrumentation and various medications. J Endod. 2000 Dec;26(12):751-5. doi: 10.1097/00004770-200012000-00022. — View Citation

Sjogren U, Hagglund B, Sundqvist G, Wing K. Factors affecting the long-term results of endodontic treatment. J Endod. 1990 Oct;16(10):498-504. doi: 10.1016/S0099-2399(07)80180-4. — View Citation

Smith CS, Setchell DJ, Harty FJ. Factors influencing the success of conventional root canal therapy--a five-year retrospective study. Int Endod J. 1993 Nov;26(6):321-33. doi: 10.1111/j.1365-2591.1993.tb00765.x. — View Citation

Stadler LE, Wennberg A, Olgart L. Instrumentation of the curved root canal using filing or reaming technique--a clinical study of technical complications. Swed Dent J. 1986;10(1-2):37-43. — View Citation

Suter B, Lussi A, Sequeira P. Probability of removing fractured instruments from root canals. Int Endod J. 2005 Feb;38(2):112-23. doi: 10.1111/j.1365-2591.2004.00916.x. — View Citation

Swartz DB, Skidmore AE, Griffin JA Jr. Twenty years of endodontic success and failure. J Endod. 1983 May;9(5):198-202. doi: 10.1016/S0099-2399(83)80092-2. No abstract available. — View Citation

Tanalp J, Kaptan F, Sert S, Kayahan B, Bayirl G. Quantitative evaluation of the amount of apically extruded debris using 3 different rotary instrumentation systems. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Feb;101(2):250-7. doi: 10.1016/j.tripleo.2005.03.002. Epub 2005 Oct 14. — View Citation

Tani-Ishii N, Teranaka T. Clinical and radiographic evaluation of root-canal obturation with obtura II. J Endod. 2003 Nov;29(11):739-42. doi: 10.1097/00004770-200311000-00013. — View Citation

Tinaz AC, Alacam T, Uzun O, Maden M, Kayaoglu G. The effect of disruption of apical constriction on periapical extrusion. J Endod. 2005 Jul;31(7):533-5. doi: 10.1097/01.don.0000152294.35507.35. — View Citation

Vande Visse JE, Brilliant JD. Effect of irrigation on the production of extruded material at the root apex during instrumentation. J Endod. 1975 Jul;1(7):243-6. doi: 10.1016/s0099-2399(75)80227-5. No abstract available. — View Citation

Vaudt J, Bitter K, Neumann K, Kielbassa AM. Ex vivo study on root canal instrumentation of two rotary nickel-titanium systems in comparison to stainless steel hand instruments. Int Endod J. 2009 Jan;42(1):22-33. doi: 10.1111/j.1365-2591.2008.01489.x. — View Citation

Wilcox LR, Roskelley C, Sutton T. The relationship of root canal enlargement to finger-spreader induced vertical root fracture. J Endod. 1997 Aug;23(8):533-4. doi: 10.1016/S0099-2399(97)80316-0. — View Citation

Williams CB, Joyce AP, Roberts S. A comparison between in vivo radiographic working length determination and measurement after extraction. J Endod. 2006 Jul;32(7):624-7. doi: 10.1016/j.joen.2005.10.044. — View Citation

World Medical Association.. World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Bull World Health Organ. 2001;79(4):373-4. Epub 2003 Jul 2. No abstract available. — View Citation

Wu MK, R'oris A, Barkis D, Wesselink PR. Prevalence and extent of long oval canals in the apical third. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000 Jun;89(6):739-43. doi: 10.1067/moe.2000.106344. — View Citation

* Note: There are 68 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With a PAI Score of < 3, = 3, or = 4 or 5	The periapical index: A scoring system for radiographic assessment of apical periodontitis. Score of 1: Normal. Score of 2: Small changes in bone structure. Score of 3: Changes in bone structure with some mineral loss (bone loss). Score of 4: Periodontitis with well-defined radiolucent area (apical periodontitis). Score of 5: Severe Periodontitis with exacerbating features (apical periodontitis).; Healed is defined by absence of a radiographic indication of apical periodontitis (PAI <3) and absence of clinical signs and symptoms other than tenderness to percussion.; Healing is defined by a reduction of radiolucency (if radiolucency is present at Baseline) combined with the absence of clinical signs and symptoms other than tenderness to percussion.	12 months
Primary	Periradicular Diagnosis	Symptomatic Apical Periodontitis: Inflammation, with clinical symptoms. Asymptomatic Apical Periodontitis: Inflammation with apical radiolucent area, does not produce clinical symptoms. Acute Apical Abscess: Inflammation characterized by rapid onset of clinical symptoms and swelling. Chronic Apical Abscess: Inflammation characterized by gradual onset, little or no discomfort, presence of a sinus tract. Condensing Osteitis: Diffuse radiopaque lesion representing a localized bony reaction to inflammation. Healed is defined by absence of a radiographic indication of apical periodontitis (PAI <3) and absence of clinical signs and symptoms other than tenderness to percussion.; Healing is defined by a reduction of radiolucency (if radiolucency is present at Baseline) combined with the absence of clinical signs and symptoms other than tenderness to percussion.	12 months