Post Endodontic PainNCT05747183
Effect of ProTaper Ultimate System on Post-endodontic Pain
A study testing ProTaper Ultimate and ProTaper Gold in people with Post Endodontic Pain, run by Gulf Medical University at 1 site in United Arab Emirates.
Trial summary
This clinical trial aims to compare the effect of Pro Taper Ultimate and Pro Taper Gold files on post-endodontic pain in molars with symptomatic apical periodontitis. The main question it aims to answer is: If there is a difference in post-endodontic pain intensity following root canal preparation using Pro Taper… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Endodontic Pain
- What is being tested?
- ProTaper Ultimate and ProTaper Gold
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 12 Sep 2022to 1 Jul 2024
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient was diagnosed with symptomatic irreversible pulpits and symptomatic apical periodontitis.
- 18-70 years old patients
- Permanent mandibular first molars.
- Teeth with a fully matured root.
- Restorable teeth indicated for endodontic treatment.
- Healthy patients.
Who cannot join
- Complex root canal morphology
- Calcified roots.
- Teeth with internal and external resorption.
- Medically compromised patients.
- Restricted mouth openings (trismus).
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Gulf Medical University
Ajman, Ajman Emirate, 4184
About this study
Official title: Comparison of Post Endodontic Pain for Preparation Using ProTaper Gold and ProTaper Ultimate Systems. A Randomized Clinical Study
This clinical trial aims to compare the effect of Pro Taper Ultimate and Pro Taper Gold files on post-endodontic pain in molars with symptomatic apical periodontitis.
The main question it aims to answer is:
If there is a difference in post-endodontic pain intensity following root canal preparation using Pro Taper Ultimate and Pro Taper Gold files in molar diagnosed with symptomatic apical periodontitis?
Participants will undergo root canal treatment using Pro Taper Ultimate and Pro Taper Gold files.
Researchers will compare [Pro Taper Ultimate and Pro Taper Gold files] to see the intensity of post-endodontic pain
Read the detailed description
The study will be conducted on 40 first mandibular molars; with 20 first mandibular molars in each group (n=20). The patient will be asked to pick an opaque sealed envelope that will contain a number from 1 to 2. The resultant number will determine in which group the participants will be placed.
Group I: Root canal preparation using Pro Taper Ultimate. Group II: Root canal preparation using Pro Taper Gold.
Procedural steps:
- Vitality will be assessed using cold tests and electric pulp testing before the procedure is carried out. Besides, mobility, palpation, and percussion tests will be done to assess periapical health. In order to ensure that the cold and electrical pulp tests are working, and a response is elicited, both tests will be carried out on patients not included in the study.
- All the patients will receive local anesthesia: 2% lidocaine with 1:100,000 epinephrine.
- Each tooth will be isolated using a rubber dam, and the access cavity will be prepared using a round bur (no.4) and tapered fissure diamond bur under copious water.
- After removal of coronal pulp tissues using a sterile excavator, the working length will be determined with stainless steel hand K-files size #10 and the use of an apex locator and confirmed using intraoral periapical radiographs.
- Hand instrumentation to 15-size K files.
- Group I will be prepared using ProTaper Ultimate files.
- Group II will be prepared using ProTaper Gold files.
- Apical patency will be maintained throughout the shaping procedure using the #10 file between each instrument.
- All the canals will be irrigated with 10 mL of 3% NaOCl between each file during the whole preparation procedure.
- All the root canals will be obturated directly after preparation.
- All the teeth will be restored using resin composite restoration.
- Conditions
- Post Endodontic Pain
- Being tested
- ProTaper Ultimate, ProTaper Gold
- Keywords
- Post endodontic pain, ProTaper Gold, ProTaper Ultimate, Root canal preparation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProTaper UltimateProcedure or surgery
Root canal preparation using ProTaper Ultimate files.
ProTaper GoldProcedure or surgery
Root canal preparation using ProTaper Gold files.
| Study group | Role | What they receive |
|---|---|---|
| ProTaper Ultimate | Experimental | Root canal preparation using ProTaper Ultimate files. Receives: Procedure: ProTaper Ultimate |
| ProTaper Gold files | Active comparator | Root canal preparation using ProTaper Gold files. Receives: Procedure: ProTaper Gold |
What is being measured
The primary outcome is the main question the study is designed to answer.
The level of post-endodontic pain
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
Measured: 24 hours
The level of post-endodontic pain
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
Measured: 72 hours
The level of post-endodontic pain
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start12 Sep 2022
- Primary completion12 Jan 2024
- Study completion1 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Endodontic PainStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulf Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747183
- Sponsor's protocol ID
- IRB/COD/STD/33/June-2022
- Status last verified
- Sep 2024
- First submitted
- 17 Feb 2023
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hajwel M, Elemam R, Elsewify T, Eid B. Effect of ProTaper Ultimate and ProTaper Gold on Postoperative Pain in Mandibular First Molars With Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis: A Randomized Control Clinical Trial. Pain Res Manag. 2025 Oct 30;2025:9718875. doi: 10.1155/prm/9718875. eCollection 2025.
PubMed 41211526
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post Endodontic Pain for Preparation Using ProTaper Gold and ProTaper Ultimate Systems. A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT05747183
- Acronym / sponsor ID
- IRB/COD/STD/33/June-2022
- Conditions
- Post Endodontic Pain
- Keywords
- Post endodontic pain, ProTaper Gold, ProTaper Ultimate, Root canal preparation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Gulf Medical UniversityUniversity, hospital or other
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 12 Jan 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 28 Feb 2023 (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 clinical trial aims to compare the effect of Pro Taper Ultimate and Pro Taper Gold files on post-endodontic pain in molars with symptomatic apical periodontitis.
The main question it aims to answer is:
If there is a difference in post-endodontic pain intensity following root canal preparation using Pro Taper Ultimate and Pro Taper Gold files in molar diagnosed with symptomatic apical periodontitis?
Participants will undergo root canal treatment using Pro Taper Ultimate and Pro Taper Gold files.
Researchers will compare [Pro Taper Ultimate and Pro Taper Gold files] to see the intensity of post-endodontic pain
Detailed description
The study will be conducted on 40 first mandibular molars; with 20 first mandibular molars in each group (n=20). The patient will be asked to pick an opaque sealed envelope that will contain a number from 1 to 2. The resultant number will determine in which group the participants will be placed.
Group I: Root canal preparation using Pro Taper Ultimate. Group II: Root canal preparation using Pro Taper Gold.
Procedural steps:
- Vitality will be assessed using cold tests and electric pulp testing before the procedure is carried out. Besides, mobility, palpation, and percussion tests will be done to assess periapical health. In order to ensure that the cold and electrical pulp tests are working, and a response is elicited, both tests will be carried out on patients not included in the study.
- All the patients will receive local anesthesia: 2% lidocaine with 1:100,000 epinephrine.
- Each tooth will be isolated using a rubber dam, and the access cavity will be prepared using a round bur (no.4) and tapered fissure diamond bur under copious water.
- After removal of coronal pulp tissues using a sterile excavator, the working length will be determined with stainless steel hand K-files size #10 and the use of an apex locator and confirmed using intraoral periapical radiographs.
- Hand instrumentation to 15-size K files.
- Group I will be prepared using ProTaper Ultimate files.
- Group II will be prepared using ProTaper Gold files.
- Apical patency will be maintained throughout the shaping procedure using the #10 file between each instrument.
- All the canals will be irrigated with 10 mL of 3% NaOCl between each file during the whole preparation procedure.
- All the root canals will be obturated directly after preparation.
- All the teeth will be restored using resin composite restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ProTaper Ultimate | Experimental | Procedure: ProTaper UltimateRoot canal preparation using ProTaper Ultimate files. |
| ProTaper Gold files | Active comparator | Procedure: ProTaper GoldRoot canal preparation using ProTaper Gold files. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient was diagnosed with symptomatic irreversible pulpits and symptomatic apical periodontitis.
- 18-70 years old patients
- Permanent mandibular first molars.
- Teeth with a fully matured root.
- Restorable teeth indicated for endodontic treatment.
Key exclusion criteria (5 listed)
- Complex root canal morphology
- Calcified roots.
- Teeth with internal and external resorption.
- Medically compromised patients.
- Restricted mouth openings (trismus).
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 |
|---|---|---|
| ProTaper UltimateRoot canal preparation using ProTaper Ultimate files. | Procedure or surgery | ProTaper Ultimate |
| ProTaper GoldRoot canal preparation using ProTaper Gold files. | Procedure or surgery | ProTaper Gold files |
Primary outcome
The level of post-endodontic pain
Time frame: 24 hours
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
The level of post-endodontic pain
Time frame: 72 hours
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
The level of post-endodontic pain
Time frame: 1 week
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
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 14 Sep 2026.
- Derived from this study: PubMed 41211526Hajwel M, Elemam R, Elsewify T, Eid B. Effect of ProTaper Ultimate and ProTaper Gold on Postoperative Pain in Mandibular First Molars With Symptomatic Irreversible Pulpitis and Symptomatic Apical Periodontitis: A Randomized Control Clinical Trial. Pain Res Manag. 2025 Oct 30;2025:9718875. doi: 10.1155/prm/9718875. eCollection 2025.
Related trials for Post Endodontic Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Not yet recruiting
Effect of Intracanal Cryotherapy on Pain, Anxiety, and Salivary Irisin After Root Canal Treatment
Postoperative Pain After Endodontic Treatment, Dental Anxiety
Recruiting
Cryotherapy, PGE2, NGF Levels and Pain After Endodontic Retreatment
Asymptomatic Apical Periodontitis, Endodontic Retreatment
Recruiting
Effect of Different Apical Motion Algorithms on Postoperative Pain After Root Canal Treatment
Apical Periodontitis, Postoperative Pain After Endodontic Treatment
Not yet recruiting
Photobiomodulation After Nonsurgical Root Canal Treatment
Symptomatic Apical Periodontitis, Postoperative Pain
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 ProTaper Ultimate and ProTaper Gold in people with Post Endodontic Pain, run by Gulf Medical University at 1 site in United Arab Emirates.
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 6 inclusion and 5 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 14 Sep 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 United Arab Emirates. 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 level of post-endodontic pain (time frame: 24 hours). The study lists 3 primary outcomes in all. 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 NCT05747183, which also lists 1 linked publication.
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 14 Sep 2026.