Endodontic InflammationNCT07779148
Evaluation of the Effect of Different Irrigation Activation Methods During Endodontic Retreatment
A study testing Xp Finisher R file in people with Endodontic Inflammation, run by Minia University at 1 site in Egypt.
Trial summary
The persistent and secondary intraradicular infections are the primary causes of post-treatment disease following endodontic treatment of any tooth. When conventional root canal treatment fails, endodontic retreatment is often the preferred option, as it represents one of the most conservative approaches. Read more about this study
- Who is it for?
- Ages 13 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontic Inflammation
- What is being tested?
- Xp Finisher R file
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2026to 10 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 13 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients with mature teeth.
- Patients with failed previous Endo treatment related by periapical periodontitis
- Single Rooted with single root canal.
- Patients should be free from any systemic disease that may affect predictable outcome.
- Patients who agree to the consent and will commit to follow-up period
Who cannot join
- Patients with immature roots.
- Patients with any systemic disease that may affect normal healing.
- Patients with swelling.
- Pregnant females.
- Patients who could/would not participate in follow-up.
- Patients with old age.
Show all 9Show fewer
- Teeth with periodontal involvement.
- Teeth with vertical root fractures.
- Non-restorable teeth
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Dentistery Hospital, Minia University
Minya
Ahmed Ali Yossef, Lecturer, +201007335293, ahmed.yousef@mu.edu.eg
About this study
Official title: Evaluation of the Effect of Different Irrigation Activation Methods During Endodontic Retreatment on Postoperative Pain and Periapical Healing in Single-Rooted Teeth: A Randomized Controlled Clinical Trial
The persistent and secondary intraradicular infections are the primary causes of post-treatment disease following endodontic treatment of any tooth. When conventional root canal treatment fails, endodontic retreatment is often the preferred option, as it represents one of the most conservative approaches.
Endodontic retreatment involves removing old root canal filling material followed by cleaning, shaping, and refilling the canals. It may be associated with postoperative pain due to periapical tissue irritation and apical extrusion of debris during instrumentation.
Read the detailed description
Endodontic retreatment involves removing old root canal filling material followed by cleaning, shaping, and refilling the canals. It may be associated with postoperative pain due to periapical tissue irritation and apical extrusion of debris during instrumentation.
Also, the retreatment procedure plays a critical role in enhancing periapical healing and improving long-term outcomes in failed initial treatments.
Activation of irrigants during endodontic retreatment enhances the removal of residual gutta-percha, sealers, and debris, especially in lateral canals and complex areas. It also boosts disinfectant effectiveness, improving canal cleanliness and retreatment outcomes.
Ultrasonic activation uses high frequency vibrations to enhance irrigant penetration and fluid dynamics during endodontic retreatment. It improves the removal of residual filling materials and debris more effectively than conventional irrigation. The technique promotes cavitation and acoustic streaming, boosting disinfectant effectiveness and reducing bacterial load. Overall, ultrasonic activation enhances canal cleaning and contributes to better retreatment outcomes.
XP endo Finisher R is a specialized endodontic instrument designed for retreatment to improve removal of residual root filling materials from canals that conventional files cannot fully clean, especially in oval or curved anatomies. It uses flexible MaxWire alloy that expands in the canal, increasing contact with walls and enhancing removal of remnants and debris. Studies using micro CT imaging show that XP endo Finisher R significantly reduces filling material volume compared to some conventional techniques and is effective as a supplementary step after primary retreatment files .
CBCT provides three dimensional imaging that allows more accurate assessment of periapical healing and detection of residual pathology following endodontic retreatment compared with conventional 2 D radiographs. It is more sensitive in identifying persistent apical lesions and missed anatomy that may impact retreatment success. CBCT evaluation can influence clinical decision making and treatment planning by revealing details not seen in traditional imaging.
Systematic reviews show CBCT based outcome assessments often report different success rates due to this increased diagnostic sensitivity. Overall, CBCT contributes to a more comprehensive evaluation of retreatment outcomes and helps guide management further.
Despite the increasing use of irrigation activation techniques during endodontic retreatment, limited clinical evidence exists comparing XP-endo Finisher R with ultrasonic activation regarding postoperative pain and periapical healing outcomes.
- Conditions
- Endodontic Inflammation
- Being tested
- Xp Finisher R file
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xp Finisher R fileProcedure or surgery
Also called Ultrasonic activation
to evaluate the incidence and severity of postoperative pain using a numeric rating scale at 24, 48, and 72 hours and periapical healing via CBCT following retreatment with two different irrigation activation techniques:
- Xp Finisher R file activation of irrigation.
- Ultrasonic activation of irrigation.
| Study group | Role | What they receive |
|---|---|---|
| Xp Finisher R file Group | Active comparator | About 17 cases suffering from caries then the Caries will be removed with a sterile stone will undergo Xp Shaper R file for irrigation activation during retreatment procedure Receives: Procedure: Xp Finisher R file |
| Ultrasonic activation Group | Active comparator | About 17 cases suffering from caries then the Caries will be removed with a sterile stone will undergo Ultrasonic activation of irrigation activation during retreatment procedure Receives: Procedure: Xp Finisher R file |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Operative Pain
Assessing the post operative pain measured by a numerical pain rating scale (NRS) where the level of pain will be recorded as follows: 0 reading represents "no pain" ; 1- 3 reading represents "mild pain" ; 4- 6 reading represents "moderate pain" and 7- 10 reading representative sever pain.
Measured: from 6 hours to 48 hours after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start1 Aug 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion10 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic InflammationStudies of the same condition, open and under way.
- More trials run by Minia 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
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdy Mohy Eldeen, Minia University
- Investigators
- Wael Hussien kamel, M.D, Study chair, Professor of Endodontics Head of Endodontic Department,Faculty of Dentistry,Future University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07779148
- Sponsor's protocol ID
- Endodontic Retreatment
- Status last verified
- Aug 2026
- First submitted
- 18 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Different Irrigation Activation Methods During Endodontic Retreatment on Postoperative Pain and Periapical Healing in Single-Rooted Teeth: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07779148
- Acronym / sponsor ID
- Endodontic Retreatment
- Conditions
- Endodontic Inflammation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 10 Aug 2027 (estimated)
- First posted
- 21 Aug 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.
The persistent and secondary intraradicular infections are the primary causes of post-treatment disease following endodontic treatment of any tooth. When conventional root canal treatment fails, endodontic retreatment is often the preferred option, as it represents one of the most conservative approaches.
Endodontic retreatment involves removing old root canal filling material followed by cleaning, shaping, and refilling the canals. It may be associated with postoperative pain due to periapical tissue irritation and apical extrusion of debris during instrumentation.
Detailed description
Endodontic retreatment involves removing old root canal filling material followed by cleaning, shaping, and refilling the canals. It may be associated with postoperative pain due to periapical tissue irritation and apical extrusion of debris during instrumentation.
Also, the retreatment procedure plays a critical role in enhancing periapical healing and improving long-term outcomes in failed initial treatments.
Activation of irrigants during endodontic retreatment enhances the removal of residual gutta-percha, sealers, and debris, especially in lateral canals and complex areas. It also boosts disinfectant effectiveness, improving canal cleanliness and retreatment outcomes.
Ultrasonic activation uses high frequency vibrations to enhance irrigant penetration and fluid dynamics during endodontic retreatment. It improves the removal of residual filling materials and debris more effectively than conventional irrigation. The technique promotes cavitation and acoustic streaming, boosting disinfectant effectiveness and reducing bacterial load. Overall, ultrasonic activation enhances canal cleaning and contributes to better retreatment outcomes.
XP endo Finisher R is a specialized endodontic instrument designed for retreatment to improve removal of residual root filling materials from canals that conventional files cannot fully clean, especially in oval or curved anatomies. It uses flexible MaxWire alloy that expands in the canal, increasing contact with walls and enhancing removal of remnants and debris. Studies using micro CT imaging show that XP endo Finisher R significantly reduces filling material volume compared to some conventional techniques and is effective as a supplementary step after primary retreatment files .
CBCT provides three dimensional imaging that allows more accurate assessment of periapical healing and detection of residual pathology following endodontic retreatment compared with conventional 2 D radiographs. It is more sensitive in identifying persistent apical lesions and missed anatomy that may impact retreatment success. CBCT evaluation can influence clinical decision making and treatment planning by revealing details not seen in traditional imaging.
Systematic reviews show CBCT based outcome assessments often report different success rates due to this increased diagnostic sensitivity. Overall, CBCT contributes to a more comprehensive evaluation of retreatment outcomes and helps guide management further.
Despite the increasing use of irrigation activation techniques during endodontic retreatment, limited clinical evidence exists comparing XP-endo Finisher R with ultrasonic activation regarding postoperative pain and periapical healing outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xp Finisher R file Group | Active comparator | Procedure: Xp Finisher R fileAbout 17 cases suffering from caries then the Caries will be removed with a sterile stone will undergo Xp Shaper R file for irrigation activation during retreatment procedure |
| Ultrasonic activation Group | Active comparator | Procedure: Xp Finisher R fileAbout 17 cases suffering from caries then the Caries will be removed with a sterile stone will undergo Ultrasonic activation of irrigation activation during retreatment procedure |
Who may qualify
- Ages
- 13 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients with mature teeth.
- Patients with failed previous Endo treatment related by periapical periodontitis
- Single Rooted with single root canal.
- Patients should be free from any systemic disease that may affect predictable outcome.
- Patients who agree to the consent and will commit to follow-up period
Key exclusion criteria (9 listed)
- Patients with immature roots.
- Patients with any systemic disease that may affect normal healing.
- Patients with swelling.
- Pregnant females.
- Patients who could/would not participate in follow-up.
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 |
|---|---|---|
| Xp Finisher R fileAlso: Ultrasonic activationto evaluate the incidence and severity of postoperative pain using a numeric rating scale at 24, 48, and 72 hours and periapical healing via CBCT following retreatment with two different irrigation activation techniques: 1. Xp Finisher R file activation of irrigation. 2. Ultrasonic activation of irrigation. | Procedure or surgery | Ultrasonic activation Group, Xp Finisher R file Group |
Primary outcome
Post Operative Pain
Time frame: from 6 hours to 48 hours after the procedure
Assessing the post operative pain measured by a numerical pain rating scale (NRS) where the level of pain will be recorded as follows: 0 reading represents "no pain" ; 1- 3 reading represents "mild pain" ; 4- 6 reading represents "moderate pain" and 7- 10 reading representative sever pain.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
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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.
Wael Hussien kamel, M.D study chair
Professor of Endodontics Head of Endodontic Department,Faculty of Dentistry,Future University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Xp Finisher R file in people with Endodontic Inflammation, run by Minia 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 21 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Magdy Mohy Eldeen Abdulrazzak, MSC (+201153661666, Dentist.magdy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post Operative Pain (time frame: from 6 hours to 48 hours after the procedure). 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 21 Aug 2026.