Necrotic PulpNCT07327996
Evaluation of Pain Relief and Bacterial Reduction After Using Calcium Hydroxide With Mesoporous Silica Nanoparticles as an Intracanal Medicament in Necrotic Mandibular Molars: A Randomized Controlled Clinical Trial
A study testing Calcium Hydroxide Intracanal medication, mesoporous silica nanoparticles paste and Calcium Hydroxide + mesoporous silica nanoparticles in people with Necrotic Pulp, run by Future University in Egypt at 1 site in Egypt.
Trial summary
This study compares how well different root canal medications reduce pain and bacteria after treatment of lower molar teeth with necrotic pulp. It tests whether adding mesoporous silica nanoparticles-antibacterial particles-to calcium hydroxide makes the treatment more effective. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Necrotic Pulp
- What is being tested?
- Calcium Hydroxide Intracanal medication, mesoporous silica nanoparticles paste and Calcium Hydroxide + mesoporous silica nanoparticles
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to Jul 2026
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients with an age range between 18 to 40.
- No sex predilection.
- Patients with necrotic pulp.
- Patients able to sign informed consent.
- Restorable teeth.
- Positive patient's acceptance for participating in the study.
- Type III distal and mesial canal of first mandibular molar.
Who cannot join
- Pregnant females
- Medically compromised patients.
- Patients having analgesics before the treatment
- If antibiotics have been administrated during the past two weeks pre-operatively.
- Patients having bruxism or clenching
- Patients having sever malocclusion associated with traumatic occlusion.
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- Teeth that have:
- Peri-apical radiolucency
- Root resorption.
- Pulp stones or calcifications.
- Previous endodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Post-operative Pain and Bacterial Load Reduction After Incorporation of Mesoporous Silica Nanoparticles in Calcium Hydroxide Intracanal Medicament in Mandibular First Molar Teeth With Necrotic Pulp. "Randomized Controlled Clinical Trial"
This study compares how well different root canal medications reduce pain and bacteria after treatment of lower molar teeth with necrotic pulp. It tests whether adding mesoporous silica nanoparticles-antibacterial particles-to calcium hydroxide makes the treatment more effective. Forty-two adult patients will be randomly assigned to receive either calcium hydroxide alone, nanoparticles alone, or a mix of both for one week during root canal therapy. measure patients' pain levels after 6h,12h,24,48h and 72 hours from treatment and the number of bacteria before and after treatment to see which method gives the best results. The goal is to make root canal treatments more comfortable and successful for future patients.
- Conditions
- Necrotic Pulp
- Being tested
- Calcium Hydroxide Intracanal medication, mesoporous silica nanoparticles paste, Calcium Hydroxide + mesoporous silica nanoparticles
- Keywords
- postoperative pain, bacterial load
- Medical subject headings
- Dental Pulp Necrosis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium Hydroxide Intracanal medicationProcedure or surgery
root canals filled with calcium hydroxide paste as intracanal medication for 1week
mesoporous silica nanoparticles pasteProcedure or surgery
root canals filled with mesoporous silica nanoparticles for 1 week
Calcium Hydroxide + mesoporous silica nanoparticlesProcedure or surgery
Root canal filled with Intracanal medication by combination between mesoporous silica nanoparticles with calcium hydroxide paste for one week.
| Study group | Role | What they receive |
|---|---|---|
| The root canals will be filled with calcium hydroxide paste | Active comparator | using calcium hydroxide paste as intracanal medication for 1week Receives: Procedure: Calcium Hydroxide Intracanal medication |
| The root canal will be filled with mesoporous silica nanoparticles paste. | Active comparator | using mesoporous silica nanoparticles paste as intracanal medication for week Receives: Procedure: mesoporous silica nanoparticles paste |
| root canals will be filled with mesoporous silica nanoparticles with calcium hydroxide paste. | Active comparator | using mesoporous silica nanoparticles with calcium hydroxide paste as intracanal medication for 1week Receives: Procedure: Calcium Hydroxide + mesoporous silica nanoparticles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain after application of different intracanal medications
measuring Post-operative pain by Numerical rate scale and pain level will be assigned to one of 4 categorical score: none(0) - mild(1-3), severe(7-10) after 6h,12h,24,48h
Measured: from 6 to 72 hours from the treatment
Secondary outcomes (1)
bacterial load change after intracanal medication
Recording the percentage of bacterial load reduction by collecting samples by paper points, first sample after access cavity and before RCT, second sample after mechanical instrumentation, third sample after removing intracanal medication from the canal
Measured: immediately in the intervention and after 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start1 Sep 2025
- Primary completion30 Apr 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Necrotic PulpStudies 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
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, raneem mohamed, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07327996
- Sponsor's protocol ID
- raneemICM10
- Status last verified
- Oct 2025
- First submitted
- 25 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post-operative Pain and Bacterial Load Reduction After Incorporation of Mesoporous Silica Nanoparticles in Calcium Hydroxide Intracanal Medicament in Mandibular First Molar Teeth With Necrotic Pulp. "Randomized Controlled Clinical Trial"
- ClinicalTrials.gov ID
- NCT07327996
- Acronym / sponsor ID
- raneemICM10
- Conditions
- Necrotic Pulp
- Keywords
- postoperative pain, bacterial load
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 8 Jan 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.
This study compares how well different root canal medications reduce pain and bacteria after treatment of lower molar teeth with necrotic pulp. It tests whether adding mesoporous silica nanoparticles-antibacterial particles-to calcium hydroxide makes the treatment more effective. Forty-two adult patients will be randomly assigned to receive either calcium hydroxide alone, nanoparticles alone, or a mix of both for one week during root canal therapy. measure patients' pain levels after 6h,12h,24,48h and 72 hours from treatment and the number of bacteria before and after treatment to see which method gives the best results. The goal is to make root canal treatments more comfortable and successful for future patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The root canals will be filled with calcium hydroxide paste | Active comparator | Procedure: Calcium Hydroxide Intracanal medicationusing calcium hydroxide paste as intracanal medication for 1week |
| The root canal will be filled with mesoporous silica nanoparticles paste. | Active comparator | Procedure: mesoporous silica nanoparticles pasteusing mesoporous silica nanoparticles paste as intracanal medication for week |
| root canals will be filled with mesoporous silica nanoparticles with calcium hydroxide paste. | Active comparator | Procedure: Calcium Hydroxide + mesoporous silica nanoparticlesusing mesoporous silica nanoparticles with calcium hydroxide paste as intracanal medication for 1week |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
Key exclusion criteria (11 listed)
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 |
|---|---|---|
| Calcium Hydroxide Intracanal medicationroot canals filled with calcium hydroxide paste as intracanal medication for 1week | Procedure or surgery | The root canals will be filled with calcium hydroxide paste |
| mesoporous silica nanoparticles pasteroot canals filled with mesoporous silica nanoparticles for 1 week | Procedure or surgery | The root canal will be filled with mesoporous silica nanoparticles paste. |
| Calcium Hydroxide + mesoporous silica nanoparticlesRoot canal filled with Intracanal medication by combination between mesoporous silica nanoparticles with calcium hydroxide paste for one week. | Procedure or surgery | root canals will be filled with mesoporous silica nanoparticles with calcium hydroxide paste. |
Primary outcome
Post-operative pain after application of different intracanal medications
Time frame: from 6 to 72 hours from the treatment
measuring Post-operative pain by Numerical rate scale and pain level will be assigned to one of 4 categorical score: none(0) - mild(1-3), severe(7-10) after 6h,12h,24,48h
1 secondary outcome
bacterial load change after intracanal medication
Time frame: immediately in the intervention and after 1 week
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 8 Jan 2026.
- 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.
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 Calcium Hydroxide Intracanal medication, mesoporous silica nanoparticles paste and Calcium Hydroxide + mesoporous silica nanoparticles in people with Necrotic Pulp, 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 7 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 8 Jan 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?
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 after application of different intracanal medications (time frame: from 6 to 72 hours from the treatment). 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 8 Jan 2026.