Post Operative PainNCT05305742
Evaluation of Postoperative Pain and Bacterial Load Reduction With ProTaper Ultimate Versus ProTaper Gold Rotary Systems
A study testing Instrument Design in people with Post Operative Pain, run by Cairo University at 1 site in Egypt.
Trial summary
This study aims to research the effect of different instrument designs by comparing protaper ultimate versus protaper gold systems on root canal preparation by evaluating post-operative pain and bacterial count reduction following single visit treatment in patients with necrotic pulp in maxillary premolar teeth. Read more about this study
- Who is it for?
- Ages 22 to 45 years
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Instrument Design
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2022to 3 May 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 22 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient's age ranges between 22 to 45 years with no sex predilection.
- Medically free patients.
- Maxillary permanent premolar teeth:
- Diagnosed clinically with pulp necrosis.
- No or mild preoperative pain.
- Radiographic evidence of two roots or single root with double canals.
Show all 10Show fewer
- no/slight widening of the periodontal membrane space.
- No response to cold pulp tester and ethyl chloride spray.
- Patients who can understand Modified Visual Analogue Scale (VAS).
- Patients' acceptance to participate in the trial.
Who cannot join
- Medically compromised patients.
- Pregnant women.
- If analgesics or antibiotics have been administrated by the patient during the past 7 days preoperatively.
- Patients reporting bruxism or clenching.
- Teeth with:
- Vital teeth. ii. Single canal maxillary premolar teeth iii. Association with swelling or fistulous tract. iv. Acute peri-apical abscess and swelling. v. Mobility Grade II or III. vi. Pocket depth more than 5mm. vii. Previous root canal therapy. viii. Non-restorable teeth: Hopeless tooth
- Immature teeth.
- Radiographic evidence of external or internal root resorption vertical root fracture, perforation, calcification, root caries.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Postoperative Pain and Bacterial Load Reduction After Canal Preparation With ProTaper Ultimate Versus ProTaper Gold Rotary Systems in Patients With Necrotic Maxillary Premolars (Randomized Clinical Trial)
This study aims to research the effect of different instrument designs by comparing protaper ultimate versus protaper gold systems on root canal preparation by evaluating post-operative pain and bacterial count reduction following single visit treatment in patients with necrotic pulp in maxillary premolar teeth.
- Conditions
- Post Operative Pain
- Being tested
- Instrument Design
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrument DesignOther
Research the effect of different instrument designs on root canal preparation by evaluating bacterial count reduction and post-operative pain
| Study group | Role | What they receive |
|---|---|---|
| Protaper Ultimate | Experimental | Not described Receives: Other: Instrument Design |
| Protaper Gold | Active comparator | Not described Receives: Other: Instrument Design |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative Pain
Intensity of pain felt after endodontic treatment recorded by the patient using modified Visual Analogue Scale where 0=no pain, 1-3=mild pain, 4-6=moderate pain and 7-10=severe pain
Measured: Postoperative pain will be measured by modified Visual Analogue Scale immediately, and at 6, 12, 24 and 48 hours postoperatively.
Secondary outcomes (2)
Number of needed analgesic tablets in case of intolerable pain
The patient will record the number of analgesic tablets taken in case of intolerable pain
Measured: Patient will be contacted after 48 hours after endodontic treatment to know the number of analgesic tablets taken
Antibacterial Effectiveness
Bacterial counting using agar Culture technique
Measured: First as a Baseline (T0): After the access cavity Sample 1 will be taken, after 15 minutes (T1) mechanical instrumentation will be done and Sample 2 will be taken, after 5 minutes from T1 (T2) final irrigation will be done and Sample 3 will be taken.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start10 Apr 2022
- Primary completion24 Apr 2025
- Study completion3 May 2025
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 Operative PainStudies 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
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Hassan Abed, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05305742
- Sponsor's protocol ID
- ENDO3-3-5
- Status last verified
- Oct 2026
- First submitted
- 24 Dec 2021
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abed KH, Hashem AAR, Lutfy RA, Eissa SA, Morsy DA. Effect of different rotary instrument designs (protaper ultimate and protaper gold) on postoperative pain and bacterial reduction: a randomized clinical trial. BMC Oral Health. 2026 Mar 25;26(1):698. doi: 10.1186/s12903-026-07973-9.
PubMed 41882642
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Pain and Bacterial Load Reduction After Canal Preparation With ProTaper Ultimate Versus ProTaper Gold Rotary Systems in Patients With Necrotic Maxillary Premolars (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT05305742
- Acronym / sponsor ID
- ENDO3-3-5
- Conditions
- Post Operative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Apr 2022 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 3 May 2025 (actual)
- First posted
- 31 Mar 2022 (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 research the effect of different instrument designs by comparing protaper ultimate versus protaper gold systems on root canal preparation by evaluating post-operative pain and bacterial count reduction following single visit treatment in patients with necrotic pulp in maxillary premolar teeth.
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 | Other: Instrument Design |
| Protaper Gold | Active comparator | Other: Instrument Design |
Who may qualify
- Ages
- 22 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Patient's age ranges between 22 to 45 years with no sex predilection.
- Medically free patients.
- Maxillary permanent premolar teeth:
- Patients who can understand Modified Visual Analogue Scale (VAS).
- Patients' acceptance to participate in the trial.
Key exclusion criteria (8 listed)
- Medically compromised patients.
- Pregnant women.
- If analgesics or antibiotics have been administrated by the patient during the past 7 days preoperatively.
- Patients reporting bruxism or clenching.
- Teeth with:
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 |
|---|---|---|
| Instrument DesignResearch the effect of different instrument designs on root canal preparation by evaluating bacterial count reduction and post-operative pain | Other | Protaper Gold, Protaper Ultimate |
Primary outcome
Post Operative Pain
Time frame: Postoperative pain will be measured by modified Visual Analogue Scale immediately, and at 6, 12, 24 and 48 hours postoperatively.
Intensity of pain felt after endodontic treatment recorded by the patient using modified Visual Analogue Scale where 0=no pain, 1-3=mild pain, 4-6=moderate pain and 7-10=severe pain
2 secondary outcomes
Number of needed analgesic tablets in case of intolerable pain
Time frame: Patient will be contacted after 48 hours after endodontic treatment to know the number of analgesic tablets taken
Antibacterial Effectiveness
Time frame: First as a Baseline (T0): After the access cavity Sample 1 will be taken, after 15 minutes (T1) mechanical instrumentation will be done and Sample 2 will be taken, after 5 minutes from T1 (T2) final irrigation will be done and Sample 3 will be taken.
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 28 Oct 2026.
- Derived from this study: PubMed 41882642Abed KH, Hashem AAR, Lutfy RA, Eissa SA, Morsy DA. Effect of different rotary instrument designs (protaper ultimate and protaper gold) on postoperative pain and bacterial reduction: a randomized clinical trial. BMC Oral Health. 2026 Mar 25;26(1):698. doi: 10.1186/s12903-026-07973-9.
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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 Instrument Design in people with Post Operative Pain, 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 10 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 28 Oct 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 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?
Post Operative Pain (time frame: Postoperative pain will be measured by modified Visual Analogue Scale immediately, and at 6, 12, 24 and 48 hours postoperatively.). 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 NCT05305742, 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 28 Oct 2026.