Symptomatic Irreversible PulpitisWOPP-IPNCT07510490
Comparison of WaveOne and ProTaper Systems on Postoperative Pain in Irreversible Pulpitis Patients
A study testing WaveOne Reciprocating System and ProTaper Rotary System in people with Symptomatic Irreversible Pulpitis, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
Trial summary
This study aims to compare two commonly used root canal instrumentation systems, WaveOne (reciprocating system) and ProTaper (rotary system), in patients diagnosed with symptomatic irreversible pulpitis. Root canal treatment is performed to remove inflamed pulp tissue, disinfect the canal, and relieve pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- WaveOne Reciprocating System and ProTaper Rotary System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Aug 2025to 29 Jan 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18-60 years Patients diagnosed with symptomatic irreversible pulpitis Patients requiring root canal treatment in permanent teeth Teeth with canal curvature ≤25° (assessed using Schneider's method) Patients willing to provide informed consent
Who cannot join
- Patients with systemic illness Pregnant patients Patients with hypersensitivity to nonsteroidal anti-inflammatory drugs Teeth with apical pathology or periapical lesions Teeth with root resorption or internal ankylosis History of dental trauma in the affected tooth Teeth with malposition or severe malocclusion Patients with periodontal disease (periodontal index <3) Patients with trismus or sinus tract Patients with severe anxiety affecting dental procedures
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Armed Forces Institute of Dentistry
Rawalpindi, Punjab Province, 44000
About this study
Official title: Comparison Between Root Canal Preparation Using WaveOne Reciprocating and ProTaper Rotary Instruments on Postoperative Pain in Patients With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
This study aims to compare two commonly used root canal instrumentation systems, WaveOne (reciprocating system) and ProTaper (rotary system), in patients diagnosed with symptomatic irreversible pulpitis. Root canal treatment is performed to remove inflamed pulp tissue, disinfect the canal, and relieve pain. However, some patients experience pain after the procedure, particularly within the first few days.
In this randomized controlled trial, 146 patients will be assigned to receive root canal treatment using either WaveOne or ProTaper instruments. All procedures will be performed under standardized clinical conditions by a single operator. Patients will be asked to record their pain levels using a Numerical Rating Scale (NRS) at specific time intervals after treatment, including 6, 12, 24, 48, and 72 hours, and at one week.
The purpose of this study is to determine whether one instrumentation system results in less postoperative pain compared to the other. The findings may help improve patient comfort and guide dentists in selecting the most appropriate root canal instrumentation technique.
Read the detailed description
Root canal treatment is a commonly performed dental procedure aimed at eliminating inflamed or infected pulp tissue and preventing further periapical complications. Despite advancements in endodontic techniques, postoperative pain remains a frequent concern, particularly in patients with symptomatic irreversible pulpitis.
Mechanical preparation of the root canal system plays a critical role in treatment success. Nickel-titanium (NiTi) instruments are widely used for this purpose and are available in different kinematic systems, including reciprocating single-file systems (such as WaveOne) and continuous rotary multi-file systems (such as ProTaper). These systems differ in their motion, number of files used, and potential for apical extrusion of debris, which may influence postoperative pain.
Previous studies comparing reciprocating and rotary systems have reported inconsistent results regarding postoperative pain outcomes. Some evidence suggests that rotary systems may be associated with reduced early postoperative pain, possibly due to more controlled instrumentation and reduced debris extrusion. However, other studies have found no significant difference between the two systems.
This randomized controlled trial is designed to compare postoperative pain following root canal treatment using WaveOne and ProTaper systems in patients with symptomatic irreversible pulpitis. A total of 146 patients will be randomly allocated into two groups. All treatments will be performed in two visits under standardized clinical conditions by a single operator to minimize variability.
Local anesthesia will be administered, and working length will be determined using an ultrasonic apex locator and radiographic verification. Instrumentation will be performed according to manufacturer guidelines for each system. Irrigation protocols and temporary restoration procedures will be standardized across both groups.
Postoperative pain will be assessed using the Numerical Rating Scale (NRS). Patients will record their pain intensity at multiple time intervals after the procedure. Analgesic intake will also be documented. At the second visit, obturation will be completed using standard techniques.
The primary outcome of this study is the intensity of postoperative pain at different time intervals. Secondary outcomes include the duration of pain and the need for analgesic medication. Statistical analysis will be performed to compare outcomes between the two groups.
The results of this study are expected to provide clinically relevant evidence regarding the effect of instrumentation technique on postoperative pain and may assist clinicians in making evidence-based decisions to improve patient outcomes.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- WaveOne Reciprocating System, ProTaper Rotary System
- Keywords
- Root Canal Treatment, Reciprocating Instruments, Rotary Instruments, Postoperative Pain, Endodontics
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaveOne Reciprocating SystemDevice
Also called WaveOne Files
Root canal instrumentation performed using a single-file reciprocating nickel-titanium system following the manufacturer's recommended protocol. File selection is based on canal negotiation with hand K-files. The system uses a reciprocating motion to prepare the canal, aiming to reduce instrumentation time and debris extrusion. All procedures are carried out under standardized clinical conditions.
ProTaper Rotary SystemDevice
Also called ProTaper Universal
Root canal instrumentation performed using a multi-file continuous rotary nickel-titanium system according to the manufacturer's protocol. The sequence includes shaping and finishing files (S1, SX, S2, F1, with F2/F3 as required) to achieve canal preparation. The system operates in continuous rotation and is used under standardized clinical conditions.
| Study group | Role | What they receive |
|---|---|---|
| WaveOne Reciprocating Instrumentation | Experimental | Participants in this arm will undergo root canal treatment using the WaveOne reciprocating single-file system according to the manufacturer's protocol. Instrumentation will be performed under standardized clinical conditions, and postoperative pain will be assessed using the Numerical Rating Scale (NRS) at predefined time intervals. Receives: Device: WaveOne Reciprocating System |
| ProTaper Rotary Instrumentation | Active comparator | Participants in this arm will undergo root canal treatment using the ProTaper rotary multi-file system according to the manufacturer's protocol. Treatment will be performed under standardized clinical conditions, and postoperative pain will be recorded using the Numerical Rating Scale (NRS) at specified time intervals. Receives: Device: ProTaper Rotary System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of Postoperative Pain Following Root Canal Instrumentation
Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates worst possible pain. Patients will record their pain scores at specified time intervals after root canal instrumentation. Median pain scores will be compared between the two groups.
Measured: 6, 12, 24, 48, and 72 hours after instrumentation, and at 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start11 Aug 2025
- Primary completion18 Jan 2026
- Study completion29 Jan 2026
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.
- 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
- Model description
- Participants will be randomly assigned to one of two parallel groups to receive root canal treatment using either WaveOne reciprocating instrumentation or ProTaper rotary instrumentation. Outcomes will be compared between groups over the same follow-up period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Dentistry, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdullah, Armed Forces Institute of Dentistry, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510490
- Sponsor's protocol ID
- AFID2
- Other IDs
- AFID-2025-RCT-02
- Acronym
- WOPP-IP
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 3 Apr 2026
- 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 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Root Canal Preparation Using WaveOne Reciprocating and ProTaper Rotary Instruments on Postoperative Pain in Patients With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07510490
- Acronym / sponsor ID
- WOPP-IP / AFID2
- Conditions
- Symptomatic Irreversible Pulpitis
- Keywords
- Root Canal Treatment, Reciprocating Instruments, Rotary Instruments, Postoperative Pain, Endodontics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Armed Forces Institute of Dentistry, PakistanUniversity, hospital or other
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 18 Jan 2026 (actual)
- Study completion
- 29 Jan 2026 (actual)
- First posted
- 3 Apr 2026 (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.
This study aims to compare two commonly used root canal instrumentation systems, WaveOne (reciprocating system) and ProTaper (rotary system), in patients diagnosed with symptomatic irreversible pulpitis. Root canal treatment is performed to remove inflamed pulp tissue, disinfect the canal, and relieve pain. However, some patients experience pain after the procedure, particularly within the first few days.
In this randomized controlled trial, 146 patients will be assigned to receive root canal treatment using either WaveOne or ProTaper instruments. All procedures will be performed under standardized clinical conditions by a single operator. Patients will be asked to record their pain levels using a Numerical Rating Scale (NRS) at specific time intervals after treatment, including 6, 12, 24, 48, and 72 hours, and at one week.
The purpose of this study is to determine whether one instrumentation system results in less postoperative pain compared to the other. The findings may help improve patient comfort and guide dentists in selecting the most appropriate root canal instrumentation technique.
Detailed description
Root canal treatment is a commonly performed dental procedure aimed at eliminating inflamed or infected pulp tissue and preventing further periapical complications. Despite advancements in endodontic techniques, postoperative pain remains a frequent concern, particularly in patients with symptomatic irreversible pulpitis.
Mechanical preparation of the root canal system plays a critical role in treatment success. Nickel-titanium (NiTi) instruments are widely used for this purpose and are available in different kinematic systems, including reciprocating single-file systems (such as WaveOne) and continuous rotary multi-file systems (such as ProTaper). These systems differ in their motion, number of files used, and potential for apical extrusion of debris, which may influence postoperative pain.
Previous studies comparing reciprocating and rotary systems have reported inconsistent results regarding postoperative pain outcomes. Some evidence suggests that rotary systems may be associated with reduced early postoperative pain, possibly due to more controlled instrumentation and reduced debris extrusion. However, other studies have found no significant difference between the two systems.
This randomized controlled trial is designed to compare postoperative pain following root canal treatment using WaveOne and ProTaper systems in patients with symptomatic irreversible pulpitis. A total of 146 patients will be randomly allocated into two groups. All treatments will be performed in two visits under standardized clinical conditions by a single operator to minimize variability.
Local anesthesia will be administered, and working length will be determined using an ultrasonic apex locator and radiographic verification. Instrumentation will be performed according to manufacturer guidelines for each system. Irrigation protocols and temporary restoration procedures will be standardized across both groups.
Postoperative pain will be assessed using the Numerical Rating Scale (NRS). Patients will record their pain intensity at multiple time intervals after the procedure. Analgesic intake will also be documented. At the second visit, obturation will be completed using standard techniques.
The primary outcome of this study is the intensity of postoperative pain at different time intervals. Secondary outcomes include the duration of pain and the need for analgesic medication. Statistical analysis will be performed to compare outcomes between the two groups.
The results of this study are expected to provide clinically relevant evidence regarding the effect of instrumentation technique on postoperative pain and may assist clinicians in making evidence-based decisions to improve patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of two parallel groups to receive root canal treatment using either WaveOne reciprocating instrumentation or ProTaper rotary instrumentation. Outcomes will be compared between groups over the same follow-up period.
| Arm | Type | Receives |
|---|---|---|
| WaveOne Reciprocating Instrumentation | Experimental | Device: WaveOne Reciprocating SystemParticipants in this arm will undergo root canal treatment using the WaveOne reciprocating single-file system according to the manufacturer's protocol. Instrumentation will be performed under standardized clinical conditions, and postoperative pain will be assessed using the Numerical Rating Scale (NRS) at predefined time intervals. |
| ProTaper Rotary Instrumentation | Active comparator | Device: ProTaper Rotary SystemParticipants in this arm will undergo root canal treatment using the ProTaper rotary multi-file system according to the manufacturer's protocol. Treatment will be performed under standardized clinical conditions, and postoperative pain will be recorded using the Numerical Rating Scale (NRS) at specified time intervals. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients aged 18-60 years Patients diagnosed with symptomatic irreversible pulpitis Patients requiring root canal treatment in permanent teeth Teeth with canal curvature ≤25° (assessed using Schneider's method) Patients willing to provide informed consent
Key exclusion criteria (1 listed)
- Patients with systemic illness Pregnant patients Patients with hypersensitivity to nonsteroidal anti-inflammatory drugs Teeth with apical pathology or periapical lesions Teeth with root resorption or internal ankylosis History of dental trauma in the affected tooth Teeth with malposition or severe malocclusion Patients with periodontal disease (periodontal index <3) Patients with trismus or sinus tract Patients with severe anxiety affecting dental procedures
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 |
|---|---|---|
| WaveOne Reciprocating SystemAlso: WaveOne FilesRoot canal instrumentation performed using a single-file reciprocating nickel-titanium system following the manufacturer's recommended protocol. File selection is based on canal negotiation with hand K-files. The system uses a reciprocating motion to prepare the canal, aiming to reduce instrumentation time and debris extrusion. All procedures are carried out under standardized clinical conditions. | Device | WaveOne Reciprocating Instrumentation |
| ProTaper Rotary SystemAlso: ProTaper UniversalRoot canal instrumentation performed using a multi-file continuous rotary nickel-titanium system according to the manufacturer's protocol. The sequence includes shaping and finishing files (S1, SX, S2, F1, with F2/F3 as required) to achieve canal preparation. The system operates in continuous rotation and is used under standardized clinical conditions. | Device | ProTaper Rotary Instrumentation |
Primary outcome
Intensity of Postoperative Pain Following Root Canal Instrumentation
Time frame: 6, 12, 24, 48, and 72 hours after instrumentation, and at 1 week
Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates worst possible pain. Patients will record their pain scores at specified time intervals after root canal instrumentation. Median pain scores will be compared between the two groups.
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 3 Apr 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WaveOne Reciprocating System and ProTaper Rotary System in people with Symptomatic Irreversible Pulpitis, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
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 1 inclusion and 1 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 3 Apr 2026. 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 Pakistan. 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?
Intensity of Postoperative Pain Following Root Canal Instrumentation (time frame: 6, 12, 24, 48, and 72 hours after instrumentation, and at 1 week). 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 3 Apr 2026.