Symptomatic Irreversible PulpitisNCT06640231
The Effect of XP-Endo Finisher Activation of Bioceramic Sealer on Postoperative Pain in Mandibular First Molar With Symptomatic Irreversible Pulpitis
A study testing sealer activation after cleaning and shaping with XP-Endo Finisher in people with Symptomatic Irreversible Pulpitis, run by Future University in Egypt at 1 site in Egypt.
Trial summary
The aim of endodontic obturation is to make a complete sealing along the length of the root canal system to ensuring the peri radicular tissue healing and sustained health. Disadvantages of gutta-percha-based root filling materials is lack of adhesiveness to canal wall dentin. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- sealer activation after cleaning and shaping with XP-Endo Finisher
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to 1 Apr 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age ranges from 18 to 40 years old.
- No sex predilection.
- Patients seeking root canal treatment.
- Systematically healthy patient (ASA I, II).
- Patient who can understand numerical rate scale and sign an informed consent.
- Mandibular first molar teeth with:
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- Preoperative sharp (moderate or severe) pain.
- Vital response of pulp tissue to cold pulp tester (ethyl chloride spray).
- Normal periapical radiographic appearance.
Who cannot join
- Patients with American association of anesthesiologists (ASA) classification other than ASA T\& II.
- Patients who have already ingested preoperative medication, such as analgesics, non-steroidal or steroidal anti-inflammatory drugs, within 12 hours of the start of treatment.
- Patients with NSAIDs allergy.
- Patients having two or more adjacent teeth needing root canal therapy.
- Pregnant patients.
- Patients with bleeding disorder.
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- Patients with long term corticosteroid use
- Teeth having;
- Necrotic pulp.
- History or presence of swelling or fistulous tract.
- Acute / chronic periapical abscess.
- Mobility more than grade 1.
- Pocket depth more than 5mm.
- No possible restorability.
- Previous root canal treatment.
- Periapical radiolucency.
- External or internal resorption.
- Vertical root fracture.
- TMJ problems, bruxism, clenching or traumatic occlusion.
- Inability to understand and perform the given instructions.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Future University in Egypt
Cairo, New Cairo, 11835
Amira Ali Heteba, Researcher, 01001022651 ext. +20, amiraaly311@yahoo.com
About this study
The aim of endodontic obturation is to make a complete sealing along the length of the root canal system to ensuring the peri radicular tissue healing and sustained health. Disadvantages of gutta-percha-based root filling materials is lack of adhesiveness to canal wall dentin. So, a sealer or cement has to be used with gutta-percha to achieve a fluid-tight seal and fill the space between the canal wall dentin and the obturating material.
Drawbacks of resin-based sealer are difficult preparation technique of deep root canal cavity which also limit dentin bonding, difficult to be removed from the canal in retreatment cases and its shrinkage during setting.
Read more
Bio-ceramic root canal sealers become popular in recent years because of their unique chemical and physical properties. These sealers are consisting of biocompatible materials that resemble the of tooth structure natural composition so bio-ceramic sealers are an ideal choice for root canal treatment. Bio-ceramic sealers are better than traditional sealers due to their multiple physical properties for example excellent sealing ability, dimensional stability, and low solubility. These properties ensure that the sealers achieve a tight seal, inhibiting bacterial leakage and decreasing the risk of reinfection. Diaroot Bioaggregate (DiaDent), a white nanoparticle-sized ceramic cement composed of calcium silicate, calcium hydroxide and hydroxyapatite and considered a modified version of MTA, with the advantage of being aluminium-free in composition, a fact that contributes to its greater biocompatibility with periradicular tissue.Root canal sealers activation may improve their penetration into dentinal tubules and improve sealability and antimicrobial effects.
Recently, a non-tapered nickel-titanium rotary instrument (XP-endo Finisher; FKG, La Chaux-de-Fonds, Switzerland) has been designed to increase the efficiency in root canal wall cleaning specifically with limited impact on dentine throughout the literature, XP efficacy in decreasing microorganisms, dissolving organic tissue from artificial cavities in combination with NaOCl and penetrating into the isthmus has been analyzed.
The aim of this study to evaluate the effect of XP-Endo Finisher activation of Bioceramic sealer on postoperative pain in mandibular first molar with symptomatic irreversible pulpitis.
This study consists of 30 patients divided into 2 group each group having 15 patients.
Intervention:
Bioceramic sealer activation with XP Endo Finisher.
Control group:
Bioceramic sealer without activation.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- sealer activation after cleaning and shaping with XP-Endo Finisher, negative control where canals are obturated directly without sealer activation
- Keywords
- Postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sealer activation after cleaning and shaping with XP-Endo FinisherOther
activation of sealer before the obturation of root canals
negative control where canals are obturated directly without sealer activationOther
sealer after cleaning and shaping before the obturation without using activation method
| Study group | Role | What they receive |
|---|---|---|
| Bioceramic sealer activation with XP Endo Finisher. | Active comparator | Not described Receives: Other: sealer activation after cleaning and shaping with XP-Endo Finisher |
| Bioceramic sealer without activation. | Active comparator | Not described Receives: Other: negative control where canals are obturated directly without sealer activation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain after sealer activation with XP-Endo Finisher in comparison to without sealer activation
Measuring of post-operative pain by Numerical rate scale(NRS) and pain level will be assigned to one of 4 categorical scores: None (0); Mild (1-3); Moderate (4-6); Severe (7-10).
Measured: Immediately after obturation, 6-, 12-, 24- and 48-hours post-operative.
Secondary outcomes (1)
Number of analgesic tablets taken after endodontic treatment with sealer activation in comparison to without sealer activation
Measuring of number of analgesic tablets taken after endodontic treatment by counting.
Measured: Up to 48 hours postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start1 Nov 2024
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Apr 2026 (estimated)
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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Ali Fahmy Heteba, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640231
- Sponsor's protocol ID
- FUE.REC(21)/7-2024
- Status last verified
- Oct 2024
- First submitted
- 7 Oct 2024
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of XP-Endo Finisher Activation of Bioceramic Sealer on Postoperative Pain in Mandibular First Molar With Symptomatic Irreversible Pulpitis
- ClinicalTrials.gov ID
- NCT06640231
- Acronym / sponsor ID
- FUE.REC(21)/7-2024
- Conditions
- Symptomatic Irreversible Pulpitis
- Keywords
- Postoperative pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 15 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.
The aim of endodontic obturation is to make a complete sealing along the length of the root canal system to ensuring the peri radicular tissue healing and sustained health. Disadvantages of gutta-percha-based root filling materials is lack of adhesiveness to canal wall dentin. So, a sealer or cement has to be used with gutta-percha to achieve a fluid-tight seal and fill the space between the canal wall dentin and the obturating material.
Drawbacks of resin-based sealer are difficult preparation technique of deep root canal cavity which also limit dentin bonding, difficult to be removed from the canal in retreatment cases and its shrinkage during setting.
Bio-ceramic root canal sealers become popular in recent years because of their unique chemical and physical properties. These sealers are consisting of biocompatible materials that resemble the of tooth structure natural composition so bio-ceramic sealers are an ideal choice for root canal treatment. Bio-ceramic sealers are better than traditional sealers due to their multiple physical properties for example excellent sealing ability, dimensional stability, and low solubility. These properties ensure that the sealers achieve a tight seal, inhibiting bacterial leakage and decreasing the risk of reinfection. Diaroot Bioaggregate (DiaDent), a white nanoparticle-sized ceramic cement composed of calcium silicate, calcium hydroxide and hydroxyapatite and considered a modified version of MTA, with the advantage of being aluminium-free in composition, a fact that contributes to its greater biocompatibility with periradicular tissue.Root canal sealers activation may improve their penetration into dentinal tubules and improve sealability and antimicrobial effects.
Recently, a non-tapered nickel-titanium rotary instrument (XP-endo Finisher; FKG, La Chaux-de-Fonds, Switzerland) has been designed to increase the efficiency in root canal wall cleaning specifically with limited impact on dentine throughout the literature, XP efficacy in decreasing microorganisms, dissolving organic tissue from artificial cavities in combination with NaOCl and penetrating into the isthmus has been analyzed.
The aim of this study to evaluate the effect of XP-Endo Finisher activation of Bioceramic sealer on postoperative pain in mandibular first molar with symptomatic irreversible pulpitis.
This study consists of 30 patients divided into 2 group each group having 15 patients.
Intervention:
Bioceramic sealer activation with XP Endo Finisher.
Control group:
Bioceramic sealer without activation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bioceramic sealer activation with XP Endo Finisher. | Active comparator | Other: sealer activation after cleaning and shaping with XP-Endo Finisher |
| Bioceramic sealer without activation. | Active comparator | Other: negative control where canals are obturated directly without sealer activation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age ranges from 18 to 40 years old.
- No sex predilection.
- Patients seeking root canal treatment.
- Systematically healthy patient (ASA I, II).
- Patient who can understand numerical rate scale and sign an informed consent.
Key exclusion criteria (20 listed)
- Patients with American association of anesthesiologists (ASA) classification other than ASA T\& II.
- Patients who have already ingested preoperative medication, such as analgesics, non-steroidal or steroidal anti-inflammatory drugs, within 12 hours of the start of treatment.
- Patients with NSAIDs allergy.
- Patients having two or more adjacent teeth needing root canal therapy.
- Pregnant patients.
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 |
|---|---|---|
| sealer activation after cleaning and shaping with XP-Endo Finisheractivation of sealer before the obturation of root canals | Other | Bioceramic sealer activation with XP Endo Finisher. |
| negative control where canals are obturated directly without sealer activationsealer after cleaning and shaping before the obturation without using activation method | Other | Bioceramic sealer without activation. |
Primary outcome
Post-operative pain after sealer activation with XP-Endo Finisher in comparison to without sealer activation
Time frame: Immediately after obturation, 6-, 12-, 24- and 48-hours post-operative.
Measuring of post-operative pain by Numerical rate scale(NRS) and pain level will be assigned to one of 4 categorical scores: None (0); Mild (1-3); Moderate (4-6); Severe (7-10).
1 secondary outcome
Number of analgesic tablets taken after endodontic treatment with sealer activation in comparison to without sealer activation
Time frame: Up to 48 hours postoperatively.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sealer activation after cleaning and shaping with XP-Endo Finisher in people with Symptomatic Irreversible Pulpitis, run by Future University in Egypt 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 9 inclusion and 20 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: status not confirmed, as of the sponsor's last update on 29 Jun 2025. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain after sealer activation with XP-Endo Finisher in comparison to without sealer activation (time frame: Immediately after obturation, 6-, 12-, 24- and 48-hours post-operative.). 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 29 Jun 2025.