Dental PainNCT06625853
XP-Endo Finisher on Postoperative Pain in Retreatment Cases Using Mtwo R Files
A study testing Mtwo R files with Xp-Endo finisher file and Mtwo R files in people with Dental Pain and Endodontically Treated Teeth, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Introduction: Postoperative pain is one of the most critical issues in our daily practice. , postoperative pain control is essential for patient satisfaction and comfort. When primary root canal treatment fails, root canal retreatment aims to heal apical periodontitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Pain, Endodontically Treated Teeth
- What is being tested?
- Mtwo R files with Xp-Endo finisher file and Mtwo R files
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Sep 2023to 23 Apr 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Teeth with mature apices.
- Patients with no systemic diseases.
- No analgesic, anti-inflammatory, or antibiotic intake during 7 days before treatment.
- Teeth showing failure of initial root canal treatment and radiograph evidence of periapical bone destruction
Who cannot join
- Multi rooted teeth.
- Teeth with open apices.
- Teeth with cracks, calcification, root caries, fractures, external or internal resorption.
- Allergies to local anesthetic agents.
- Presence of severe pain and/or acute apical abscesses
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Supplementary Use of the XP-Endo Finisher on Postoperative Pain in Retreatment Cases Using Mtwo R Files (Randomized Clinical Trial)
Introduction: Postoperative pain is one of the most critical issues in our daily practice. , postoperative pain control is essential for patient satisfaction and comfort. When primary root canal treatment fails, root canal retreatment aims to heal apical periodontitis.
Aim of study: To compare between postoperative pain (POS) after endodontic retreatment using NI-TI rotary files Mtwo R alone and in conjunction with XP endo finisher .
Materials and Methods: This research is a randomized clinical trial conducted in a parallel design on 50 patients needing retreatment. They will be divided into two groups, group 1 retreatment with Mtwo R, group 2 retreatment with Mtwo R followed by Xp - Endo finisher. Postoperative pain levels will be evaluated at 24 hours, 48 hours, 72 hours, and 7 days following the removal of the obturation mat erial. The assessment of pain will be done through clinical examination, The Defense and veterans pain rating scale (DVPRS) and by the intake of pain killer
- Conditions
- Dental Pain, Endodontically Treated Teeth
- Being tested
- Mtwo R files with Xp-Endo finisher file, Mtwo R files
- Medical subject headings
- Toothache, Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mtwo R files with Xp-Endo finisher fileOther
XP-endo Finisher file will be inserted without rotation into the root canals filled with 2.5% NaOCl and will be activated (800 rpm; torque of 1 N.cm) for
1 min in each canal using slow and gentle 7-8 mm lengthwise movements.
Mtwo R filesOther
obturation material will be removed using Mtwo R (VDW, Munich, Germany)files attached to an endodontic motor (Ecube, seachin, Korea) with a constant speed of 280 rpm, as suggested by the manufacturer. Mtwo R 25/0.05 will be used to empty the coronal and middle thirds of the root. Mtwo R 15/0.05 will be used to reach the working length.
| Study group | Role | What they receive |
|---|---|---|
| Mtwo R files without Xp-endo finisher file. | Experimental | Not described Receives: Other: Mtwo R files |
| Mtwo R files followed by Xp-Endo finisher file | Experimental | Not described Receives: Other: Mtwo R files with Xp-Endo finisher file |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain
Word descriptors are attached to each number on the DVPRS
0 = No pain
- = Hardly noticeable pain
- = Noticeable pain, but does not interfere with activities
- = Somewhat distracting pain
- = Distracting pain, but does not affect normal activities
- = Pain interrupts some activities
- = Hard to ignore pain, avoidance of daily activities
- = Pain is the main focus of attention, prevents daily activities
- = Awful pain, difficult to do anything
- = Unbearable pain, cannot do anything
- = As bad as pain can be, nothing else matters
Measured: 24-hours,48-hours,72hours and 7 days
Secondary outcomes (1)
change in analgesics intake according to severity of pain according to WHO Analgesic Ladder
First Step - Mild pain: non-opioid analgesics such as nonsteroidal antiinflammatory drugs (NSAIDs) or acetaminophen with or without adjuvants.
- Second Step - Moderate pain: weak opioids (hydrocodone, codeine, tramadol) with or without non-opioid analgesics and with or without adjuvants.
- Third Step - Severe and persistent pain: potent opioids (morphine, methadone, fentanyl, oxycodone, buprenorphine, tapentadol, hydromorphone, oxymorphone) with or without non-opioid analgesics, and with or without adjuvants.
Measured: 24-hours,48-hours,72hours and 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start12 Sep 2023
- Primary completion23 Apr 2024
- Study completion23 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625853
- Sponsor's protocol ID
- 0738-08/2023
- Status last verified
- Oct 2024
- First submitted
- 1 Oct 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementary Use of the XP-Endo Finisher on Postoperative Pain in Retreatment Cases Using Mtwo R Files (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT06625853
- Acronym / sponsor ID
- 0738-08/2023
- Conditions
- Dental Pain, Endodontically Treated Teeth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 12 Sep 2023 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 3 Oct 2024 (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.
Introduction: Postoperative pain is one of the most critical issues in our daily practice. , postoperative pain control is essential for patient satisfaction and comfort. When primary root canal treatment fails, root canal retreatment aims to heal apical periodontitis.
Aim of study: To compare between postoperative pain (POS) after endodontic retreatment using NI-TI rotary files Mtwo R alone and in conjunction with XP endo finisher .
Materials and Methods: This research is a randomized clinical trial conducted in a parallel design on 50 patients needing retreatment. They will be divided into two groups, group 1 retreatment with Mtwo R, group 2 retreatment with Mtwo R followed by Xp - Endo finisher. Postoperative pain levels will be evaluated at 24 hours, 48 hours, 72 hours, and 7 days following the removal of the obturation mat erial. The assessment of pain will be done through clinical examination, The Defense and veterans pain rating scale (DVPRS) and by the intake of pain killer
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mtwo R files without Xp-endo finisher file. | Experimental | Other: Mtwo R files |
| Mtwo R files followed by Xp-Endo finisher file | Experimental | Other: Mtwo R files with Xp-Endo finisher file |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Teeth with mature apices.
- Patients with no systemic diseases.
- No analgesic, anti-inflammatory, or antibiotic intake during 7 days before treatment.
- Teeth showing failure of initial root canal treatment and radiograph evidence of periapical bone destruction
Key exclusion criteria (5 listed)
- Multi rooted teeth.
- Teeth with open apices.
- Teeth with cracks, calcification, root caries, fractures, external or internal resorption.
- Allergies to local anesthetic agents.
- Presence of severe pain and/or acute apical abscesses
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 |
|---|---|---|
| Mtwo R files with Xp-Endo finisher fileXP-endo Finisher file will be inserted without rotation into the root canals filled with 2.5% NaOCl and will be activated (800 rpm; torque of 1 N.cm) for 1 min in each canal using slow and gentle 7-8 mm lengthwise movements. | Other | Mtwo R files followed by Xp-Endo finisher file |
| Mtwo R filesobturation material will be removed using Mtwo R (VDW, Munich, Germany)files attached to an endodontic motor (Ecube, seachin, Korea) with a constant speed of 280 rpm, as suggested by the manufacturer. Mtwo R 25/0.05 will be used to empty the coronal and middle thirds of the root. Mtwo R 15/0.05 will be used to reach the working length. | Other | Mtwo R files without Xp-endo finisher file. |
Primary outcome
Change in pain
Time frame: 24-hours,48-hours,72hours and 7 days
Word descriptors are attached to each number on the DVPRS 0 = No pain 1. = Hardly noticeable pain 2. = Noticeable pain, but does not interfere with activities 3. = Somewhat distracting pain 4. = Distracting pain, but does not affect normal activities 5. = Pain interrupts some activities 6. = Hard to ignore pain, avoidance of daily activities 7. = Pain is the main focus of attention, prevents daily activities 8. = Awful pain, difficult to do anything 9. = Unbearable pain, cannot do anything 10. = As bad as pain can be, nothing else matters
1 secondary outcome
change in analgesics intake according to severity of pain according to WHO Analgesic Ladder
Time frame: 24-hours,48-hours,72hours and 7 days
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 Oct 2024.
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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 Mtwo R files with Xp-Endo finisher file and Mtwo R files in people with Dental Pain and Endodontically Treated Teeth, run by Hams Hamed Abdelrahman 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 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 3 Oct 2024. 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?
Change in pain (time frame: 24-hours,48-hours,72hours and 7 days). 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 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.