NCT02953912

Brief Summary

To show whether One Shape rotary system differs from Reciproc reciprocating system in postoperative pain in patients with symptomatic irreversible pulpitis.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 31, 2016

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

November 3, 2016

Status Verified

October 1, 2016

Enrollment Period

11 months

First QC Date

October 31, 2016

Last Update Submit

November 2, 2016

Conditions

Pulpitis - Irreversible

Keywords

RotationReciprocationsingle filepostoperative painReciprocOne ShapeSymptomatic irreversible pulpitis

Outcome Measures

Primary Outcomes (1)

  • Intensity of pain after endodontic treatment

    Intensity of postoperative pain will be measured using a numerical rating scale (NRS)

    immediately after the end of treatment up to 72 hours

Secondary Outcomes (1)

  • Number of analgesic tablets taken by the patient after endodontic treatment

    Within 3 days after endodontic treatment

Study Arms (2)

Reciproc single-file.

EXPERIMENTAL

The Reciproc is a single-file nickel-titanium systems used in reciprocating motion, made of a special nickel-titanium (NiTi) alloy called M-Wire created by innovated thermal treatment process which increases flexibility and improved resistance to cyclic fatigue .

Procedure: Reciproc single-file

One Shape single-file .

ACTIVE COMPARATOR

One Shape is single file made of austenite 55- NiTi alloy characterized by different cross sectional designs ,it is used in continuous clockwise rotation for a quick and safe root canal preparation due to its flexibility and minimal fatigue. with electropolished safety tip instrument for enhanced cutting efficiency and it is delivered in a sterile blister for single use.

Procedure: One Shape single-file

Interventions

Reciproc single-filePROCEDURE

The Reciproc is a single-file nickel-titanium systems , made of a special nickel-titanium (NiTi) alloy called M-Wire created by innovated thermal treatment process which increases flexibility and improved resistance to cyclic fatigue

Reciproc single-file.
One Shape single-filePROCEDURE

One Shape is one of the few single file made of austenite 55- NiTi alloy characterized by different cross sectional designs ,it is used in continuous clockwise rotation for a quick and safe root canal preparation due to its flexibility and minimal fatigue.In addition to , the electropolished safety tip instrument for enhanced cutting efficiency and it is delivered in a sterile blister for single use.

One Shape single-file .

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • i. Age 25-45years old. ii. Males or Females. iii. Mandibular premolar teeth with:
  • Single canal
  • Preoperative sharp pain.
  • Vital response of pulp tissue.
  • Normal periapical radiographic appearance or slight widening in lamina dura.

You may not qualify if:

  • ii. Patients who have more than one tooth in the same quadrant and/or opposite quadrant that require an endodontic treatment.
  • iii. Pregnant females. iv. Patients having significant systemic disorder. v. If antibiotics have been administrated during the past two weeks preoperatively.
  • vi. Patients having bruxism or clenching. vii. Teeth that have:
  • Non-vital pulp tissues.
  • Association with swelling or fistulous tract.
  • A pocket depth greater than 5 mm.
  • Previous endodontic treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (22)

  • Sathorn C, Parashos P, Messer H. The prevalence of postoperative pain and flare-up in single- and multiple-visit endodontic treatment: a systematic review. Int Endod J. 2008 Feb;41(2):91-9. doi: 10.1111/j.1365-2591.2007.01316.x. Epub 2007 Oct 23.

    PMID: 17956561BACKGROUND

  • Gondim E Jr, Setzer FC, Dos Carmo CB, Kim S. Postoperative pain after the application of two different irrigation devices in a prospective randomized clinical trial. J Endod. 2010 Aug;36(8):1295-301. doi: 10.1016/j.joen.2010.04.012. Epub 2010 Jun 19.

    PMID: 20647083BACKGROUND

  • Neelakantan P, Sharma S. Pain after single-visit root canal treatment with two single-file systems based on different kinematics--a prospective randomized multicenter clinical study. Clin Oral Investig. 2015 Dec;19(9):2211-7. doi: 10.1007/s00784-015-1448-x. Epub 2015 Mar 15.

    PMID: 25773449BACKGROUND

  • 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.

    PMID: 11471648BACKGROUND

  • Nekoofar MH, Sheykhrezae MS, Meraji N, Jamee A, Shirvani A, Jamee J, Dummer PM. Comparison of the effect of root canal preparation by using WaveOne and ProTaper on postoperative pain: a randomized clinical trial. J Endod. 2015 May;41(5):575-8. doi: 10.1016/j.joen.2014.12.026. Epub 2015 Feb 24.

    PMID: 25720984BACKGROUND

  • Siqueira JF Jr, Rocas IN, Favieri A, Machado AG, Gahyva SM, Oliveira JC, Abad EC. Incidence of postoperative pain after intracanal procedures based on an antimicrobial strategy. J Endod. 2002 Jun;28(6):457-60. doi: 10.1097/00004770-200206000-00010.

    PMID: 12067129BACKGROUND

  • 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.

    PMID: 15980716BACKGROUND

  • 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.

    PMID: 3868692BACKGROUND

  • Harrington GW, Natkin E. Midtreatment flare-ups. Dent Clin North Am. 1992 Apr;36(2):409-23.

    PMID: 1572507BACKGROUND

  • Munoz E, Forner L, Llena C. Influence of operator's experience on root canal shaping ability with a rotary nickel-titanium single-file reciprocating motion system. J Endod. 2014 Apr;40(4):547-50. doi: 10.1016/j.joen.2013.08.027. Epub 2013 Oct 13.

    PMID: 24666909BACKGROUND

  • 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.

    PMID: 12193268BACKGROUND

  • Ruddle CJ, Machtou P, West JD. The shaping movement: fifth-generation technology. Dent Today. 2013 Apr;32(4):94, 96-9. No abstract available.

    PMID: 23659098BACKGROUND

  • 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.

    PMID: 11482718BACKGROUND

  • 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.

    PMID: 15881729BACKGROUND

  • Burklein S, Benten S, Schafer E. Shaping ability of different single-file systems in severely curved root canals of extracted teeth. Int Endod J. 2013 Jun;46(6):590-7. doi: 10.1111/iej.12037. Epub 2012 Dec 13.

    PMID: 23240965BACKGROUND

  • Park H. A comparison of Greater Taper files, ProFiles, and stainless steel files to shape curved root canals. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2001 Jun;91(6):715-8. doi: 10.1067/moe.2001.114159.

    PMID: 11402288BACKGROUND

  • Burklein S, Schafer E. Apically extruded debris with reciprocating single-file and full-sequence rotary instrumentation systems. J Endod. 2012 Jun;38(6):850-2. doi: 10.1016/j.joen.2012.02.017. Epub 2012 Apr 6.

    PMID: 22595125BACKGROUND

  • Yared G. Canal preparation using only one Ni-Ti rotary instrument: preliminary observations. Int Endod J. 2008 Apr;41(4):339-44. doi: 10.1111/j.1365-2591.2007.01351.x. Epub 2007 Dec 12.

    PMID: 18081803BACKGROUND

  • Nabeshima CK, Caballero-Flores H, Cai S, Aranguren J, Borges Britto ML, Machado ME. Bacterial removal promoted by 2 single-file systems: Wave One and One Shape. J Endod. 2014 Dec;40(12):1995-8. doi: 10.1016/j.joen.2014.07.024. Epub 2014 Aug 19.

    PMID: 25149120BACKGROUND

  • Capar ID, Arslan H. A review of instrumentation kinematics of engine-driven nickel-titanium instruments. Int Endod J. 2016 Feb;49(2):119-35. doi: 10.1111/iej.12432. Epub 2015 Feb 18.

    PMID: 25630977BACKGROUND

  • Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

    PMID: 17695343BACKGROUND

  • Labbaf H, Shakeri L, Orduie R, Bastami F. Apical Extrusion of Debris after Canal Preparation with Hand-Files Used Manually or Installed on Reciprocating Air-Driven Handpiece in Straight and Curved Canals. Iran Endod J. 2015 Summer;10(3):165-8. doi: 10.7508/iej.2015.03.004. Epub 2015 Jul 1.

    PMID: 26213538BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Shaimaa I Gawdat, Lecturer

    Department of endodontics - Faculty of Oral and Dental medicine - CU

    STUDY DIRECTOR

  • Angie G Ghoneim, Professor

    Department of endodontics - Faculty of Oral and Dental medicine - CU

    STUDY CHAIR

  • Asmaa M kamel, Student

    Department of endodontics - Faculty of Oral and Dental medicine - CU

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Asmaa M kamel, Student

CONTACT

01010266628asmaa.kamal@dentistry.cu.edu.eg

Shaimaa I Gawdat, Lecturer

CONTACT

01222235502shaimaagawdat@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator.

Study Record Dates

First Submitted

October 31, 2016

First Posted

November 3, 2016

Study Start

November 1, 2016

Primary Completion

October 1, 2017

Study Completion

January 1, 2018

Last Updated

November 3, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share