AzTrials
AzTrials

Pulpitis - IrreversibleNCT02953912

Assessment of Postoperative Pain Using Reciproc Versus One Shape Files in Patients With Irreversible Pulpitis

A study testing Reciproc single-file and One Shape single-file in people with Pulpitis - Irreversible, run by Cairo University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 25 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Pulpitis - Irreversible
What is being tested?
Reciproc single-file and One Shape single-file
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
No sites listed yet
Study dates
Nov 2016to Jan 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
  • Exclusion Criteria:i. Patients who have already consumed preoperative medication, such as analgesic, non-steroidal or steroidal anti-inflammatory drugs, within 12 hours before treatment.
Show all 13Show fewer
  • Patients who have more than one tooth in the same quadrant and/or opposite quadrant that require an endodontic treatment.
  • Pregnant females. iv. Patients having significant systemic disorder. v. If antibiotics have been administrated during the past two weeks preoperatively.
  • 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.

Who cannot join

None listed.

Trial locations and contacts

No sites are listed yet.

Asmaa M kamel, Student contact

01010266628

asmaa.kamal@dentistry.cu.edu.eg

Shaimaa I Gawdat, Lecturer contact

01222235502

shaimaagawdat@gmail.com

About this study

Official title: Assessment of Postoperative Pain After Using Reciproc Versus One Shape NiTi Systems in Patients With Symptomatic Irreversible Pulpitis.

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

Read the detailed description

Patients in the clinic of endodontics at the faculty of oral and dental medicine, Cairo University, Urban area, Cairo governorate, Egypt.

The dental Unit is Adec 200 U.S.A. The x-ray Machine is ViVi, S.r.I, Italy The x-ray films are Kodac, speed D, size 2. The operator is master degree student in the department of Endodontics. No dental assistant Time: 2016-2017 Diagnosis The diagnostic data will be collected in a case report form by the investigator and confirmed for eligibility with the assistant supervisor and will be enrolled in the study in the same day.

Diagnosis is done by the following:

Recording the chief complaint and history of pain Clinical examination will be evaluated for (sensitivity) of pulp tissues using cold testing (by using Green Endo ice), electric tester.

The patient should experience prolonged response to cold testing and positive response to electric pulp testing Radiographic examination: There should be no periapical radiolucency except for widening periodontal ligaments.

Intervention Full medical and dental history using a schematic dental chart will be obtained from all patients treated during this study. Each tooth will be evaluated for vitality (sensitivity) of pulp tissues using electric pulp tester.

The patients will be randomly divided into 2 group:

Experimental group Reciproc single-file reciprocating instrumentation system. Control group One Shape single-file rotary instrumentation system. Sequence of Procedural steps Preoperative pain will be assessed by NRS before administration of anesthesia. Local anesthesia will be achieved using 2% lidocaine (1:100,000 adrenaline). An access cavity will be performed using round bur and Endo-Z bur1.

. The tooth will be properly isolated with rubber dam. Working length will be determined using an electronic apex locator2, and working length will be confirmed by radiograph using K-file3. Then the working length will be established at 0.5 mm up to the radiographic apex.

Canals will be explored with hand K-file ISO sizes 10, 15, 20. Mechanical preparation for both groups will be as follows

Experimental group Canals will be instrumented using Reciproc4 reciprocating system set on an electric motor5, with adjusted torque and speed according to the manufacturer's instruction.

There is no need for coronal preflaring with a Gates Glidden drill or an orifice opener since the design of the Reciproc instrument allows any obstructions in the coronal third to be removed, as claimed by the - Reciproc file selection: R40 (40/0.06) manufacturer.

Control group Coronal preflaring will be performed using Gates Glidden drill. Canals will be instrumented using One Shape1 single-file (25/0.06) set on an electric motor2 with adjusted torque and speed according to the manufacturer's instructions.

For wide canals, One Shape Apical (30/0.06, 37/0.06) will be used. The rotary files will be introduced inside the canal using EDTA gel3.. Canals will be irrigated with 2.5% sodium hypochlorite solution between every subsequent instrument. It is prepared by adding 11 ml of sterile distilled water using a 27 gauge needle fit to 5ml disposable plastic syringe placed in the canal space without binding

Canals will be dried with sterile paper points and obturated using lateral condensation technique. A spreader will be used to allow space for auxiliary cones, with resin-based root canal sealer.

The tooth will be sealed by temporary restoration, and postoperative pain will be assessed immediately after the end of treatment.

The patient will be phone called for follow up after 6, 12, 24, 48 and 72 hours.

The patient will be instructed to return to complete the treatment procedures until placing a full-coverage restoration.

The patient will be instructed to take one tablet 600 mg Ibuprofen if he/she experiences severe pain.

Outcomes Primary Outcome :Intensity of postoperative pain will be measured using a numerical rating scale (NRS) immediately after the end of treatment, 6, 12, 24, 48, and 72 hours after the end of endodontic treatment.

The numerical rating scale (0-10 scale) consists of a line anchored by two extremes "0: no pain" and "10: severe pain"; patients will be asked to choose the mark that represents their level of pain from 0 to 10. Pain level will be assigned to one of 4 categorical scores:

0, None; 1, Mild (1-3); 2, Moderate (4-6); 3, Severe (7-10)

0: None

  1. Mild (1-3)
  2. Moderate (4-6)
  3. Severe (7-10)

Secondary outcome Number of analgesic taken by the patient to decrease postoperative pain up to 3 days after the end of endodontic treatment will be recorded by the patient with time intervals.

Participant Timeline:

After the patient is found eligible, he/she will be randomly assigned to either the control (One Shape) or experimental group (Reciproc) and will be treated in a single visit. At the end of treatment, patients will be asked to record postoperative pain by NRS immediately, then after 6,12,24,48 and 72 hours.

Being tested
Reciproc single-file, One Shape single-file
Keywords
Rotation, Reciprocation, single file, postoperative pain, Reciproc, One Shape, Symptomatic irreversible pulpitis
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reciproc single-fileProcedure or surgery

    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

  • One Shape single-fileProcedure or surgery

    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.

Study groups in NCT02953912
Study groupRoleWhat they receive
Reciproc single-file.ExperimentalThe 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 .
Receives: Procedure: Reciproc single-file
One Shape single-file .Active comparatorOne 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.
Receives: Procedure: One Shape single-file

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intensity of pain after endodontic treatment

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

    Measured: immediately after the end of treatment up to 72 hours

Secondary outcomes (1)
  1. Number of analgesic tablets taken by the patient after endodontic treatment

    Measured: Within 3 days after endodontic treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionOct 2017 (estimated)
  4. Study completionJan 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02953912
Sponsor's protocol ID
reciproc_one shape
Status last verified
Oct 2016
First submitted
31 Oct 2016
Last updated
3 Nov 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17956561
  • 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.

    PubMed 20647083
  • 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.

    PubMed 25773449
  • 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.

    PubMed 11471648
  • 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.

    PubMed 25720984
  • 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.

    PubMed 12067129
  • 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.

    PubMed 15980716
  • 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.

    PubMed 3868692
  • Harrington GW, Natkin E. Midtreatment flare-ups. Dent Clin North Am. 1992 Apr;36(2):409-23.

    PubMed 1572507
  • 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.

    PubMed 24666909
  • 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.

    PubMed 12193268
  • Ruddle CJ, Machtou P, West JD. The shaping movement: fifth-generation technology. Dent Today. 2013 Apr;32(4):94, 96-9. No abstract available.

    PubMed 23659098
  • 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.

    PubMed 11482718
  • 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.

    PubMed 15881729
  • 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.

    PubMed 23240965

Questions about this trial

What is this clinical trial studying?

A study testing Reciproc single-file and One Shape single-file in people with Pulpitis - Irreversible, run by Cairo University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Asmaa M kamel, Student (01010266628, asmaa.kamal@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intensity of pain after endodontic treatment (time frame: immediately after the end of treatment up to 72 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02953912, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2016.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in