Symptomatic Irreversible PulpitisNCT07133217
Comparative Evaluation of Postoperative Pain and Clinical Success
A study testing Root canal preparation with Hand Files (Dentsply Sirona), Root canal preparation with the WaveOne Gold file system (Dentsply Sirona, Ballaigues, Switzerland) and Root canal preparation with the ProTaper Ultimate file system (Dentsply Sirona) in people with Symptomatic Irreversible Pulpitis, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Sixty-three mandibular molars with vital pulp, symptomatic acute pain, and a Numerical Rating Scale (NRS) score of 7 or higher-requiring emergency treatment-were randomly allocated into three groups according to the preparation systems to be used: conventional manual instrumentation technique with hand files… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- Root canal preparation with Hand Files (Dentsply Sirona), Root canal preparation with the WaveOne Gold file system (Dentsply Sirona, Ballaigues, Switzerland) and Root canal preparation with the ProTaper Ultimate file system (Dentsply Sirona)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 11 Jun 2024to 11 Jul 2025
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients aged 18-65
- Patients who can come to regular check-ups and have high treatment motivation
- Patients who can establish an appropriate patient-doctor dialogue
- Patients without systemic disease
- Patients with teeth that have not previously undergone endodontic treatment
- Patients who meet the clinical definition of symptomatic irreversible pulpitis (pain, prolonged sensitivity to hot and cold,percussion sensitivity, pulpal bleeding)
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- Delayed positive response of teeth to cold testing and electric pulp testing
- Presence of spontaneous pain before treatment
- Mandibular first or second molar with complete root development
- Formation of large pulpal perforation during caries removing
- Presence of bleeding in the exposed pulp that cannot be stopped within 5 minutes after the pulp exposure
Who cannot join
- Patients who refused to participate in the study
- Patients at medical risk (patients with immune system diseases/systemic diseases, patients using medication),
- Patients with NSAID (non-steroidal anti-inflammatory) allergy
- Patients with allergy to the materials used during root canal treatment
- Patients who used antibiotics or analgesics before applying to the clinic
- Pregnant patients
Show all 15Show fewer
- Asymptomatic or devital teeth
- Presence of advanced periodontal disease (probing depth> 3 mm)
- Patients with more than one tooth requiring endodontic treatment
- The relevant tooth has previously undergone endodontic treatment
- The tooth needs a post-core or is a prosthetic support tooth
- Presence of calcified root canal
- Teeth with internal or external root resorption
- Teeth with open apex
- Mandibular third molars
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Postoperative Pain and Clinical Success Following Root Canal Treatment With Hand Files, ProTaper Ultimate, and WaveOne Gold Systems in Symptomatic Irreversible Pulpitis: a Randomized Clinical Trial
Sixty-three mandibular molars with vital pulp, symptomatic acute pain, and a Numerical Rating Scale (NRS) score of 7 or higher-requiring emergency treatment-were randomly allocated into three groups according to the preparation systems to be used: conventional manual instrumentation technique with hand files, reciprocating motion technique with WaveOne Gold files, and rotary motion technique with ProTaper Ultimate files.
In the first session, patients received emergency treatment with one of the three file systems, and seven days later, root canal treatments were completed using the same system within each patient group. Preoperative pain scores of patients presenting to our clinic with acute pain were recorded using the Numerical Rating Scale (NRS).
Read more
During the emergency root canal treatment session, the first group was instrumented with hand files, the second group with WaveOne Gold files, and the third group with ProTaper Ultimate files, and the emergency treatment session was completed. Shaping times were measured during the procedures.
Following the emergency session, patients were instructed to record their postoperative pain at the 6th hour, 12th hour, and on the 1st, 2nd, 3rd, 4th, 5th, 6th, and 7th days using the provided NRS.
One week after the emergency treatment session, root canal obturation was performed using each system's own gutta-percha and Bioceramic root canal sealer. Clinical and radiographic follow-ups were carried out at 6 and 12 months.
Read the detailed description
- This randomized clinical study was conducted to evaluate and compare the effects of the conventional step-back technique with hand files, the reciprocal technique with WaveOne Gold files, and the rotary technique with ProTaper Ultimate files on the frequency and intensity of pain before and after emergency treatment, as well as on clinical and radiological outcomes in symptomatic and acutely painful vital molars during root canal treatment.
Sixty-three symptomatic mandibular molars with vital pulp were randomly allocated into three groups according to the preparation system used: Hand files, WaveOne Gold, and ProTaper Ultimate. The file systems assigned to each group were used for root canal preparation in all cases.
In the rotary and reciprocating file groups, obturation was performed with their own gutta-percha using the single cone technique with Bioceramic sealer and in the conventional hand file group root canal obturation was performed with cold lateral compaction method.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- Root canal preparation with Hand Files (Dentsply Sirona), Root canal preparation with the WaveOne Gold file system (Dentsply Sirona, Ballaigues, Switzerland), Root canal preparation with the ProTaper Ultimate file system (Dentsply Sirona)
- Keywords
- Bioceramic sealer, Clinical success, Emergency treatment, Hand file, Postoperative pain, Reciprocating file, Rotary file, 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.
Root canal preparation with Hand Files (Dentsply Sirona)Device
Root canal treatments were performed with hand files
Root canal preparation with the WaveOne Gold file system (Dentsply Sirona, Ballaigues, Switzerland)Device
Root canal treatments were performed with WaveOne Gold Files
Root canal preparation with the ProTaper Ultimate file system (Dentsply Sirona)Device
Root canal treatments were performed with ProTaper Ultimate Files
| Study group | Role | What they receive |
|---|---|---|
| Conventional Manuel Instrumentation Technique Group | Active comparator | Root canals were prepared with hand files. Irrigation was performed with 10 mL of NaOCl, followed by 5 mL of 17% ethylenediaminetetraacetic acid (EDTA). Temporary coronal restoration was completed with glass ionomer cement. For this group, 72 hours after the completion of root canal preparation in the emergency intervention session, calcium hydroxide was applied to the root canals for 7 days, and the teeth were obturated using a bioceramic root canal sealer with the system-specific gutta-percha and obturation methods recommended by the manufacturers. Receives: Device: Root canal preparation with Hand Files (Dentsply Sirona) |
| Reciprocating Motion Technique Group | Active comparator | Root canals were prepared with WaveOne Gold instruments and an X-Smart Plus (Dentsply Maillefer, Switzerland) endodontic motor. Irrigation was performed with 10 mL of NaOCl, followed by 5 mL of 17% ethylenediaminetetraacetic acid (EDTA). Temporary coronal restoration was completed with glass ionomer cement. For this group, 72 hours after the completion of root canal preparation in the emergency intervention session, calcium hydroxide was applied to the root canals for 7 days, and the teeth were obturated using a bioceramic root canal sealer with the system-specific gutta-percha and obturation methods recommended by the manufacturers. Receives: Device: Root canal preparation with the WaveOne Gold file system (Dentsply Sirona, Ballaigues, Switzerland) |
| Rotation Motion Technique Group | Active comparator | Root canals were prepared with ProTaper Ultimate instruments and an X-Smart Plus (Dentsply Maillefer, Switzerland) endodontic motor. Irrigation was performed with 10 mL of NaOCl, followed by 5 mL of 17% ethylenediaminetetraacetic acid (EDTA). Temporary coronal restoration was completed with glass ionomer cement. For this group, 72 hours after the completion of root canal preparation in the emergency intervention session, calcium hydroxide was applied to the root canals for 7 days, and the teeth were obturated using a bioceramic root canal sealer with the system-specific gutta-percha and obturation methods recommended by the manufacturers. Receives: Device: Root canal preparation with the ProTaper Ultimate file system (Dentsply Sirona) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and intensity of post-obturation pain
Post-obturation pain up to 30 days after root canal treatment was measured with Numerical Rating Scale. The Numerical Rating Scale is a pain measurement scale that encompasses the following grades: 0 no pain, 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain.
Measured: up to 30-day
Secondary outcomes (1)
Clinical and radiographical success
Clinical success was determined by the absence of any clinical or radiographic indicators of inflammation or infection, and outcomes were categorized as either successful or unsuccessful.Unsuccessful ones were scored as "0" and successful ones as "1". During the clinical examination, the presence of swelling, pain, sinus tract formation, or tenderness upon percussion or palpation was documented. Periodontal probing depths were assessed for each case. Radiographic analysis evaluated the integrity of periodontal tissues and the presence or absence of periapical radiolucent areas. The level of root canal fillings was classified as short (≥2 mm from the apex), acceptable (0-2 mm), or overfilled (beyond apex).
Measured: Up to 1 year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start11 Jun 2024
- Primary completion11 Jul 2025
- Study completion11 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Ege 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
- Investigator, Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gözde Kandemir Demirci, Ege University
- Investigators
- Gözde Kandemir Demirci, Associate Professor, Principal investigator, Ege University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133217
- Sponsor's protocol ID
- 23-9.1/4
- Other IDs
- TS-GAP-2024-32255
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Postoperative Pain and Clinical Success Following Root Canal Treatment With Hand Files, ProTaper Ultimate, and WaveOne Gold Systems in Symptomatic Irreversible Pulpitis: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07133217
- Acronym / sponsor ID
- 23-9.1/4
- Conditions
- Symptomatic Irreversible Pulpitis
- Keywords
- Bioceramic sealer, Clinical success, Emergency treatment, Hand file, Postoperative pain, Reciprocating file, Rotary file, Symptomatic irreversible pulpitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 11 Jun 2024 (actual)
- Primary completion
- 11 Jul 2025 (actual)
- Study completion
- 11 Jul 2025 (actual)
- First posted
- 20 Aug 2025 (actual)
- 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.
Sixty-three mandibular molars with vital pulp, symptomatic acute pain, and a Numerical Rating Scale (NRS) score of 7 or higher-requiring emergency treatment-were randomly allocated into three groups according to the preparation systems to be used: conventional manual instrumentation technique with hand files, reciprocating motion technique with WaveOne Gold files, and rotary motion technique with ProTaper Ultimate files.
In the first session, patients received emergency treatment with one of the three file systems, and seven days later, root canal treatments were completed using the same system within each patient group. Preoperative pain scores of patients presenting to our clinic with acute pain were recorded using the Numerical Rating Scale (NRS).
During the emergency root canal treatment session, the first group was instrumented with hand files, the second group with WaveOne Gold files, and the third group with ProTaper Ultimate files, and the emergency treatment session was completed. Shaping times were measured during the procedures.
Following the emergency session, patients were instructed to record their postoperative pain at the 6th hour, 12th hour, and on the 1st, 2nd, 3rd, 4th, 5th, 6th, and 7th days using the provided NRS.
One week after the emergency treatment session, root canal obturation was performed using each system's own gutta-percha and Bioceramic root canal sealer. Clinical and radiographic follow-ups were carried out at 6 and 12 months.
Detailed description
- This randomized clinical study was conducted to evaluate and compare the effects of the conventional step-back technique with hand files, the reciprocal technique with WaveOne Gold files, and the rotary technique with ProTaper Ultimate files on the frequency and intensity of pain before and after emergency treatment, as well as on clinical and radiological outcomes in symptomatic and acutely painful vital molars during root canal treatment.
Sixty-three symptomatic mandibular molars with vital pulp were randomly allocated into three groups according to the preparation system used: Hand files, WaveOne Gold, and ProTaper Ultimate. The file systems assigned to each group were used for root canal preparation in all cases.
In the rotary and reciprocating file groups, obturation was performed with their own gutta-percha using the single cone technique with Bioceramic sealer and in the conventional hand file group root canal obturation was performed with cold lateral compaction method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Conventional Manuel Instrumentation Technique Group | Active comparator | Device: Root canal preparation with Hand Files (Dentsply Sirona)Root canals were prepared with hand files. Irrigation was performed with 10 mL of NaOCl, followed by 5 mL of 17% ethylenediaminetetraacetic acid (EDTA). Temporary coronal restoration was completed with glass ionomer cement. For this group, 72 hours after the completion of root canal preparation in the emergency intervention session, calcium hydroxide was applied to the root canals for 7 days, and the teeth were obturated using a bioceramic root canal sealer with the system-specific gutta-percha and obturation methods recommended by the manufacturers. |
| Reciprocating Motion Technique Group | Active comparator | Device: Root canal preparation with the WaveOne Gold file system (Dentsply Sirona, Ballaigues, Switzerland)Root canals were prepared with WaveOne Gold instruments and an X-Smart Plus (Dentsply Maillefer, Switzerland) endodontic motor. Irrigation was performed with 10 mL of NaOCl, followed by 5 mL of 17% ethylenediaminetetraacetic acid (EDTA). Temporary coronal restoration was completed with glass ionomer cement. For this group, 72 hours after the completion of root canal preparation in the emergency intervention session, calcium hydroxide was applied to the root canals for 7 days, and the teeth were obturated using a bioceramic root canal sealer with the system-specific gutta-percha and obturation methods recommended by the manufacturers. |
| Rotation Motion Technique Group | Active comparator | Device: Root canal preparation with the ProTaper Ultimate file system (Dentsply Sirona)Root canals were prepared with ProTaper Ultimate instruments and an X-Smart Plus (Dentsply Maillefer, Switzerland) endodontic motor. Irrigation was performed with 10 mL of NaOCl, followed by 5 mL of 17% ethylenediaminetetraacetic acid (EDTA). Temporary coronal restoration was completed with glass ionomer cement. For this group, 72 hours after the completion of root canal preparation in the emergency intervention session, calcium hydroxide was applied to the root canals for 7 days, and the teeth were obturated using a bioceramic root canal sealer with the system-specific gutta-percha and obturation methods recommended by the manufacturers. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients aged 18-65
- Patients who can come to regular check-ups and have high treatment motivation
- Patients who can establish an appropriate patient-doctor dialogue
- Patients without systemic disease
- Patients with teeth that have not previously undergone endodontic treatment
Key exclusion criteria (15 listed)
- Patients who refused to participate in the study
- Patients at medical risk (patients with immune system diseases/systemic diseases, patients using medication),
- Patients with NSAID (non-steroidal anti-inflammatory) allergy
- Patients with allergy to the materials used during root canal treatment
- Patients who used antibiotics or analgesics before applying to the clinic
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 |
|---|---|---|
| Root canal preparation with Hand Files (Dentsply Sirona)Root canal treatments were performed with hand files | Device | Conventional Manuel Instrumentation Technique Group |
| Root canal preparation with the WaveOne Gold file system (Dentsply Sirona, Ballaigues, Switzerland)Root canal treatments were performed with WaveOne Gold Files | Device | Reciprocating Motion Technique Group |
| Root canal preparation with the ProTaper Ultimate file system (Dentsply Sirona)Root canal treatments were performed with ProTaper Ultimate Files | Device | Rotation Motion Technique Group |
Primary outcome
The incidence and intensity of post-obturation pain
Time frame: up to 30-day
Post-obturation pain up to 30 days after root canal treatment was measured with Numerical Rating Scale. The Numerical Rating Scale is a pain measurement scale that encompasses the following grades: 0 no pain, 1-3 mild pain, 4-6 moderate pain, 7-10 severe pain.
1 secondary outcome
Clinical and radiographical success
Time frame: Up to 1 year follow up
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 20 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Gözde Kandemir Demirci, Associate Professor principal investigator
Ege University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Root canal preparation with Hand Files (Dentsply Sirona), Root canal preparation with the WaveOne Gold file system (Dentsply Sirona, Ballaigues, Switzerland) and Root canal preparation with the ProTaper Ultimate file system (Dentsply Sirona) in people with Symptomatic Irreversible Pulpitis, run by Ege University at 1 site in Turkey (Türkiye).
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 11 inclusion and 15 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 20 Aug 2025. 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 Turkey (Türkiye). 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?
The incidence and intensity of post-obturation pain (time frame: up to 30-day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2025.