PulpitisNCT02940704

Assessment of Postoperative Pain After Using Reciproc Versus One Shape NiTi Systems

A study testing Reciproc and One Shape in people with Pulpitis, run by Cairo University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The aim of this study is to assess the postoperative pain and the intake of analgesic medication after using Reciproc single-file reciprocating system or One Shape single-file continuous rotary system 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
What is being tested?: Reciproc and One Shape
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 siteEgypt
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

Single-rooted mandibular premolar teeth with:
Preoperative sharp pain.
Vital response of pulp tissue.
Normal periapical radiographic appearance or slight widening in lamina dura.

Who cannot join

Patients who have already consumed preoperative medication, such as analgesic, non-steroidal or steroidal anti-inflammatory drugs, within 12 hours before treatment.
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.
Pocket depth greater than 5 mm.
Previous endodontic treatment.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Endodontic Department - Faculty of Oral and Dental Medicine - Cairo University
Cairo

Other trials in Egypt

About this study

Official title: Assessment of Postoperative Pain After Using Reciproc Versus One Shape NiTi Systems in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial (Part I)

The aim of this study is to assess the postoperative pain and the intake of analgesic medication after using Reciproc single-file reciprocating system or One Shape single-file continuous rotary system in patients with symptomatic irreversible pulpitis.
Patients will be diagnosed to determine whether they are eligible for the inclusion criteria of this study or not. Patients who are eligible will then start their root canal treatment on the same visit and to be completed in one visit only. Patients will be phone called in order to record the intensity of pain, amount and frequency of analgesic intake at 6, 12, 24, 48 and 72 hours after treatment.

Read the detailed description

Full medical and dental history using a schematic dental chart will be obtained from all eligible participants. Each tooth will be evaluated for vitality (sensitivity) of pulp tissues.

The patients will be randomly divided into 2 groups:

Experimental group: Reciproc reciprocating instrumentation system.
Control group: One Shape rotary instrumentation system.
Sequence of Procedural steps

Preoperative pain will be assessed by Numerical Rating Scale (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 bur.
The tooth will be properly isolated with rubber dam.
Working length will be determined using an electronic apex locator, and working length will be confirmed by radiograph using K-file. 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 Reciproc reciprocating system set on an electric motor, with adjusted torque and speed according to the manufacturer's instructions.
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 manufacturer.
Reciproc file selection: R40 (40/0.06) is to be used.
Control group:
Coronal preflaring will be performed using Gates Glidden drill.
Canals will be instrumented using One Shape (25/0.06) set on an electric motor 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. 8.The rotary files will be introduced inside the canal using EDTA gel. 9.Canals will be irrigated with 2.5% sodium hypochlorite solution between every subsequent instrument. It is prepared by adding 10 ml of sterile distilled water to 10 ml of 5.25% sodium hypochlorite solution using a 27-gauge needle fit to 5 ml disposable plastic syringe placed as far as possible in the canal space without binding. 10.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. 11.The tooth will be sealed by temporary restoration, and postoperative pain will be assessed immediately after the end of treatment. 12.The patient will be instructed to return to complete the treatment procedures until placing a full-coverage restoration. 13.The patient will be instructed to take one tablet 400 mg Ibuprofen if he/she experiences severe pain.

Conditions: Pulpitis
Being tested: Reciproc, One Shape
Keywords: Reciproc, One Shape, reciprocation, continuous rotation, irreversible pulpitis, postoperative pain
Medical subject headings: Pulpitis, Pain, Postoperative

What participants receive

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

ReciprocProcedure or surgery
- Canals will be instrumented using Reciproc reciprocating system set on an electric motor, with adjusted torque and speed according to the manufacturer's instructions.
- 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 manufacturer.
- Reciproc file selection: R40 (40/0.06) is to be used.
One ShapeProcedure or surgery
- Coronal preflaring will be performed using Gates Glidden drill.
- Canals will be instrumented using One Shape single-file (25/0.06) set on an electric motor 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.

Study groups in NCT02940704
Study group	Role	What they receive
Reciproc	Experimental	* Reciproc (VDW, Munich, Germany) is a single file reciprocating system for mechanical instrumentation of root canals. * Size: R40 (40/0.06) Receives: Procedure: Reciproc
One Shape	Active comparator	* One Shape (MicroMega, Besançon Cedex, France) is a single file system that works by continuous rotation for mechanical instrumentation of root canals. * Size: 25/0.06 Receives: Procedure: One Shape

What is being measured

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

postoperative pain
Intensity of pain after endodontic treatment by Numerical Rating Scale (0-10)
Measured: Up to 72 hrs after treatment

Secondary outcomes (1)

Number of analgesic tablets taken after endodontic treatment
One tablet 400 mg Ibuprofen if patient experiences severe pain after treatment
Measured: up to 72 hours after treatment

Timeline

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

Nov 2016Jan 2018

First posted21 Oct 2016 (estimated)
Study startNov 2016
Primary completionMay 2017
Study completionJan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for PulpitisStudies of the same condition, open and under way.
More trials run by Cairo UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02940704
Sponsor's protocol ID: CEBC-CU-2016-10-145
Status last verified: Jul 2018
First submitted: 18 Oct 2016
Last updated: 26 Jul 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Publications

Shahi S, Asghari V, Rahimi S, Lotfi M, Samiei M, Yavari H, Shakouie S, Nezafati S. Postoperative Pain after Endodontic Treatment of Asymptomatic Teeth Using Rotary Instruments: A Randomized Clinical Trial. Iran Endod J. 2016 Winter;11(1):38-43. doi: 10.7508/iej.2016.01.008. Epub 2015 Dec 24.
PubMed 26843876
Shokraneh A, Ajami M, Farhadi N, Hosseini M, Rohani B. Postoperative endodontic pain of three different instrumentation techniques in asymptomatic necrotic mandibular molars with periapical lesion: a prospective, randomized, double-blind clinical trial. Clin Oral Investig. 2017 Jan;21(1):413-418. doi: 10.1007/s00784-016-1807-2. Epub 2016 Apr 4.
PubMed 27041109
Caviedes-Bucheli J, Azuero-Holguin MM, Gutierrez-Sanchez L, Higuerey-Bermudez F, Pereira-Nava V, Lombana N, Munoz HR. The effect of three different rotary instrumentation systems on substance P and calcitonin gene-related peptide expression in human periodontal ligament. J Endod. 2010 Dec;36(12):1938-42. doi: 10.1016/j.joen.2010.08.043. Epub 2010 Oct 15.
PubMed 21092809
Haapasalo, M. & Shen, Y. Evolution of nickel-titanium instruments: from past to future. Endod. Top. 29, 3-17 (2013).
Kucukyilmaz E, Savas S, Saygili G, Uysal B. Assessment of apically extruded debris and irrigant produced by different nickel-titanium instrument systems. Braz Oral Res. 2015;29:1-6. doi: 10.1590/1807-3107bor-2015.vol29.0002. Epub 2014 Nov 11.
PubMed 25387860
Kherlakian D, Cunha RS, Ehrhardt IC, Zuolo ML, Kishen A, da Silveira Bueno CE. Comparison of the Incidence of Postoperative Pain after Using 2 Reciprocating Systems and a Continuous Rotary System: A Prospective Randomized Clinical Trial. J Endod. 2016 Feb;42(2):171-6. doi: 10.1016/j.joen.2015.10.011. Epub 2015 Nov 29.
PubMed 26614017
Gambarini, D. G. & Glassman, G. Continuing education TF Adaptive : a novel approach to nickel-titanium instrumentation. Oral Heal. J. (2013).
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
Gambarini G, Testarelli L, De Luca M, Milana V, Plotino G, Grande NM, Rubini AG, Al Sudani D, Sannino G. The influence of three different instrumentation techniques on the incidence of postoperative pain after endodontic treatment. Ann Stomatol (Roma). 2013 Mar 20;4(1):152-5. doi: 10.11138/ads.0152. Print 2013 Jan.
PubMed 23741536
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
Relvas JB, Bastos MM, Marques AA, Garrido AD, Sponchiado EC Jr. Assessment of postoperative pain after reciprocating or rotary NiTi instrumentation of root canals: a randomized, controlled clinical trial. Clin Oral Investig. 2016 Nov;20(8):1987-1993. doi: 10.1007/s00784-015-1692-0. Epub 2015 Dec 19.
PubMed 26685850

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
Not yet recruitingPhase 4
Cost-Effectiveness of Upfront Supplemental Anaesthesia in Symptomatic Irreversible Pulpitis
Irreversible Pulpitis, Anesthesia, Local

All Pulpitis trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Postoperative Pain After Using Reciproc Versus One Shape NiTi Systems in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial (Part I)
ClinicalTrials.gov ID: NCT02940704
Acronym / sponsor ID: CEBC-CU-2016-10-145
Conditions: Pulpitis
Keywords: Reciproc, One Shape, reciprocation, continuous rotation, irreversible pulpitis, postoperative pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Cairo UniversityUniversity, hospital or other
Study start: Nov 2016 (actual)
Primary completion: May 2017 (actual)
Study completion: Jan 2018 (actual)
First posted: 21 Oct 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of this study is to assess the postoperative pain and the intake of analgesic medication after using Reciproc single-file reciprocating system or One Shape single-file continuous rotary system in patients with symptomatic irreversible pulpitis.
Patients will be diagnosed to determine whether they are eligible for the inclusion criteria of this study or not. Patients who are eligible will then start their root canal treatment on the same visit and to be completed in one visit only. Patients will be phone called in order to record the intensity of pain, amount and frequency of analgesic intake at 6, 12, 24, 48 and 72 hours after treatment.

Detailed description

Full medical and dental history using a schematic dental chart will be obtained from all eligible participants. Each tooth will be evaluated for vitality (sensitivity) of pulp tissues.

The patients will be randomly divided into 2 groups:

Experimental group: Reciproc reciprocating instrumentation system.
Control group: One Shape rotary instrumentation system.
Sequence of Procedural steps

Preoperative pain will be assessed by Numerical Rating Scale (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 bur.
The tooth will be properly isolated with rubber dam.
Working length will be determined using an electronic apex locator, and working length will be confirmed by radiograph using K-file. 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 Reciproc reciprocating system set on an electric motor, with adjusted torque and speed according to the manufacturer's instructions.
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 manufacturer.
Reciproc file selection: R40 (40/0.06) is to be used.
Control group:
Coronal preflaring will be performed using Gates Glidden drill.
Canals will be instrumented using One Shape (25/0.06) set on an electric motor 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. 8.The rotary files will be introduced inside the canal using EDTA gel. 9.Canals will be irrigated with 2.5% sodium hypochlorite solution between every subsequent instrument. It is prepared by adding 10 ml of sterile distilled water to 10 ml of 5.25% sodium hypochlorite solution using a 27-gauge needle fit to 5 ml disposable plastic syringe placed as far as possible in the canal space without binding. 10.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. 11.The tooth will be sealed by temporary restoration, and postoperative pain will be assessed immediately after the end of treatment. 12.The patient will be instructed to return to complete the treatment procedures until placing a full-coverage restoration. 13.The patient will be instructed to take one tablet 400 mg Ibuprofen if he/she experiences severe pain.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Reciproc	Experimental	Procedure: Reciproc* Reciproc (VDW, Munich, Germany) is a single file reciprocating system for mechanical instrumentation of root canals. * Size: R40 (40/0.06)
One Shape	Active comparator	Procedure: One Shape* One Shape (MicroMega, Besançon Cedex, France) is a single file system that works by continuous rotation for mechanical instrumentation of root canals. * Size: 25/0.06

Who may qualify

Ages: 25 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Preoperative sharp pain.
Vital response of pulp tissue.
Normal periapical radiographic appearance or slight widening in lamina dura.

Key exclusion criteria (8 listed)

Patients who have already consumed preoperative medication, such as analgesic, non-steroidal or steroidal anti-inflammatory drugs, within 12 hours before treatment.
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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Reciproc* Canals will be instrumented using Reciproc reciprocating system set on an electric motor, with adjusted torque and speed according to the manufacturer's instructions. * 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 manufacturer. * Reciproc file selection: R40 (40/0.06) is to be used.	Procedure or surgery	Reciproc
One Shape* Coronal preflaring will be performed using Gates Glidden drill. * Canals will be instrumented using One Shape single-file (25/0.06) set on an electric motor 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.	Procedure or surgery	One Shape

Primary outcome

postoperative pain
Time frame: Up to 72 hrs after treatment
Intensity of pain after endodontic treatment by Numerical Rating Scale (0-10)

1 secondary outcome

Number of analgesic tablets taken after endodontic treatment
Time frame: up to 72 hours after treatment

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2018.
Background: PubMed 26843876Shahi S, Asghari V, Rahimi S, Lotfi M, Samiei M, Yavari H, Shakouie S, Nezafati S. Postoperative Pain after Endodontic Treatment of Asymptomatic Teeth Using Rotary Instruments: A Randomized Clinical Trial. Iran Endod J. 2016 Winter;11(1):38-43. doi: 10.7508/iej.2016.01.008. Epub 2015 Dec 24.
Background: PubMed 27041109Shokraneh A, Ajami M, Farhadi N, Hosseini M, Rohani B. Postoperative endodontic pain of three different instrumentation techniques in asymptomatic necrotic mandibular molars with periapical lesion: a prospective, randomized, double-blind clinical trial. Clin Oral Investig. 2017 Jan;21(1):413-418. doi: 10.1007/s00784-016-1807-2. Epub 2016 Apr 4.
Background: PubMed 21092809Caviedes-Bucheli J, Azuero-Holguin MM, Gutierrez-Sanchez L, Higuerey-Bermudez F, Pereira-Nava V, Lombana N, Munoz HR. The effect of three different rotary instrumentation systems on substance P and calcitonin gene-related peptide expression in human periodontal ligament. J Endod. 2010 Dec;36(12):1938-42. doi: 10.1016/j.joen.2010.08.043. Epub 2010 Oct 15.
BackgroundHaapasalo, M. & Shen, Y. Evolution of nickel-titanium instruments: from past to future. Endod. Top. 29, 3-17 (2013).
Background: PubMed 25387860Kucukyilmaz E, Savas S, Saygili G, Uysal B. Assessment of apically extruded debris and irrigant produced by different nickel-titanium instrument systems. Braz Oral Res. 2015;29:1-6. doi: 10.1590/1807-3107bor-2015.vol29.0002. Epub 2014 Nov 11.
Background: PubMed 26614017Kherlakian D, Cunha RS, Ehrhardt IC, Zuolo ML, Kishen A, da Silveira Bueno CE. Comparison of the Incidence of Postoperative Pain after Using 2 Reciprocating Systems and a Continuous Rotary System: A Prospective Randomized Clinical Trial. J Endod. 2016 Feb;42(2):171-6. doi: 10.1016/j.joen.2015.10.011. Epub 2015 Nov 29.
BackgroundGambarini, D. G. & Glassman, G. Continuing education TF Adaptive : a novel approach to nickel-titanium instrumentation. Oral Heal. J. (2013).
Background: PubMed 25720984Nekoofar 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.
Background: PubMed 23741536Gambarini G, Testarelli L, De Luca M, Milana V, Plotino G, Grande NM, Rubini AG, Al Sudani D, Sannino G. The influence of three different instrumentation techniques on the incidence of postoperative pain after endodontic treatment. Ann Stomatol (Roma). 2013 Mar 20;4(1):152-5. doi: 10.11138/ads.0152. Print 2013 Jan.
Background: PubMed 25773449Neelakantan 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.
Background: PubMed 26685850Relvas JB, Bastos MM, Marques AA, Garrido AD, Sponchiado EC Jr. Assessment of postoperative pain after reciprocating or rotary NiTi instrumentation of root canals: a randomized, controlled clinical trial. Clin Oral Investig. 2016 Nov;20(8):1987-1993. doi: 10.1007/s00784-015-1692-0. Epub 2015 Dec 19.
Individual participant dataSharing planned: No

Related trials for Pulpitis

Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Not yet recruiting
Post-operative Pain and Clinical Outcome After Single-cone Obturation With a Calcium Silicate-based Versus Epoxy Resin Sealer
Post Operative Pain, Acute, Irreversible Pulpitis (Toothache)
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Recruiting
Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
Symptomatic Irreversible Pulpitis (SIP), Dental Pain
Not yet recruitingPhase 4
Cost-Effectiveness of Upfront Supplemental Anaesthesia in Symptomatic Irreversible Pulpitis
Irreversible Pulpitis, Anesthesia, Local

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michel K Elias, Resident principal investigator

Faculty of Oral and Dental Medicine - Cairo University

Hebatallah M El-Far, Professor study director

Faculty of Oral and Dental Medicine - Cairo University

Shaimaa I Gawdat, Lecturer study chair

Faculty of Oral and Dental Medicine - Cairo University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Reciproc and One Shape in people with Pulpitis, run by Cairo University at 1 site in Egypt.

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 4 inclusion and 8 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: finished, as of the sponsor's last update on 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

postoperative pain (time frame: Up to 72 hrs after treatment). 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 NCT02940704, which also lists 11 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 26 Jul 2018.