Pulp Necrosis, Apical PeriodontitisEarly Phase 1NCT07603934
The Effect of Different Intra-canal Medications on Postoperative Pain
A Early Phase 1 study testing ibuprofen, Nitrofurantoin and Calcium Hydroxide in people with Pulp Necrosis, Apical Periodontitis, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to assess the effect of ibuprofen, nitrofurantoin, and calcium hydroxide on postoperative pain after endodontic treatment of necrotic mandibular posterior teeth Research question/hypothesis: In patients with necrotic pulps in their mandibular posterior teeth, there would be no difference in… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pulp Necrosis, Apical Periodontitis
- What is being tested?
- ibuprofen, Nitrofurantoin and Calcium Hydroxide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2025to 15 Mar 2027
- Phase
- Early Phase 1
- 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 necrotic pulps.
- Adult, healthy patients, older than 18 years old
- Males and females.
- Patient with the ability to understand and use pain scales.
- Patient who accepts enroll to the study.
Who cannot join
- Patients' allergies or any other contraindication to any of the medications used.
- Pregnant and lactating females.
- Patients have been taking pain medication 12 hours earlier.
- Patients who have more than one symptomatic mandibular tooth in the same quadrant.
- Patients with contributory medical history (ASA>II).
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
Faculty of Oral and Dental Medicine, Egyptian Russian University
Cairo, Cairo Governorate, 4450113
Maha Nasr, Assistant professor, 01114367063, mahmouhaa87@gmail.com
maha-nasrmorsi@eru.edu.eg
About this study
Official title: Evaluation of Postoperative Pain After Using Ibuprofen, Nitrofurantoin, or Calcium Hydroxide as Intracanal Medicaments in Root Canal Treatment of Necrotic Mandibular Posterior Teeth. A Randomized Controlled Trial
The aim of this study is to assess the effect of ibuprofen, nitrofurantoin, and calcium hydroxide on postoperative pain after endodontic treatment of necrotic mandibular posterior teeth
Research question/hypothesis:
In patients with necrotic pulps in their mandibular posterior teeth, there would be no difference in the incidence and/or severity of postoperative pain after the use of ibuprofen, nitrofurantoin, or calcium hydroxide intracanal medications.
The study will evaluate postoperative pain after using either of the tested drugs as an intracanal medication amidst visits. of endodontic treatment in cases where pulp necrosis is confirmed.
Read the detailed description
- Trial design:
- A Randomized controlled, double-blind, parallel-arm, clinical trial.
- Allocation ratio 1:1:1
- Framework: superiority
- Study settings:
Outpatient clinic of Endodontics at the Faculty of Dentistry, Egyptian Russian University, Badr city, Cairo governorate, Egypt.
- Eligibility criteria
- Inclusion criteria:
- Patients with necrotic pulps.
- Adult, healthy patients, older than 18 years old
- Males and females.
- Patient with the ability to understand and use pain scales.
- Patient who accepts enroll to the study.
- Exclusion criteria:
- Patients' allergies or any other contraindication to any of the medications used.
- Pregnant and lactating females.
- Patients have been taking pain medication 12 hours earlier.
- Patients who have more than one symptomatic mandibular tooth in the same quadrant.
- Patients with contributory medical history (ASA>II).
- Diagnosis:
The diagnosis of pulp necrosis is confirmed through the patients' history, lack of response to cold testing and negative response to electric pulp tester whenever .The treatment will be done on two- visits.
- Treatment procedure: Each patient will be given an NRS chart to rate her /his presenting pain as preoperative pain. After complete mechanical preparation, each patient will be randomly assigned to either of three groups as follows, group 1: ibuprofen will be used as an intracanal medication, group 2: nitrofurantoin will be used as an intra canal medication and group 3: CaOH will be used as an intracanal medicament. The access cavity will be then sealed with temporary filling (MD-TEMP, META BIOMED CO., LTD. Chungbuuk, Korea). Post-operative instructions and appropriate post-operative rescue medication will be prescribed (400mg Ibuprofen). All patients will be asked to record their postoperative pain level felt on NRS at 6, 12, 24, 48, 72 hours and 7 days.
One week after the first visit, patients will be recalled to the clinic to complete their root canal treatment as recommended. All canals will be dried then obturated by the modified single cone technique using 0.04 taper gutta percha points and epoxy resin sealer. Patients will be referred to an operative or a fixed prosthodontics specialist for crown placement at the Faculty of Dentistry, Egyptian Russian University.
Research objective (state the aim) The aim of this study is to assess the effect of ibuprofen, nitrofurantoin and calcium hydroxide on postoperative pain after endodontic treatment of necrotic mandibular posterior teeth.
Sample size: (if calculation equation is used please state) A total of 111 patients, 37 per group needed for the clinical trial was calculated
Grouping \& Randomization used:(specify if present) Three groups Group 1: ibuprofen Group 2: nitrofurantoin Group 3: calcium hydroxide
Outcome variables:
The primary outcome the effect of ibuprofen, nitrofurantoin and calcium hydroxide on postoperative pain after endodontic treatment of necrotic mandibular posterior teeth.
Postoperative pain will be measured using NRS at 6, 12, 24, 48, 72 hours postoperatively. Numerical Rating Scale (NRS) (20): It is an 11-point scale consisting of numbers from 0 through 10; - 0 reading represents "no pain" - 1-3 readings represent "mild pain" - 4- 6 readings represent "moderate pain" - 7- 10 readings represent "severe pain"
- Conditions
- Pulp Necrosis, Apical Periodontitis
- Being tested
- ibuprofen, Nitrofurantoin, Calcium Hydroxide
- Keywords
- Necrotic Pulp
- Medical subject headings
- Dental Pulp Necrosis, Periapical Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibuprofenDrug
Ibuprofen. a NSAID, will be ground and formed into a paste to be placed inside the root canals of necrotic mandibular posterior teeth, to explore its effects on post-operative pain
NitrofurantoinDrug
Nitrofurantoin tablets will be formed into a paste to be placed inside the root canals of necrotic mandibular premolars during endodontic treatment.
Calcium HydroxideDrug
Calcium Hydroxide intracanal medicament will be placed inside the root canals of mandibular necrotic posterior teeth during endodontic treatment.
| Study group | Role | What they receive |
|---|---|---|
| ibuprofen | Experimental | Ibuprofen. a NSAID, will be ground and formed into a paste to be placed inside the root canals of necrotic mandibular posterior teeth, to explore its effects on post-operative pain Receives: Drug: ibuprofen |
| nitrofurantoin | Experimental | Not described Receives: Drug: Nitrofurantoin |
| calcium hydroxide | Active comparator | Not described Receives: Drug: Calcium Hydroxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of Postoperative pain
Postoperative pain intensity will be self-reported by patients using an 11-point Numerical rating scale (NRS), where 0 represents "no paon" and 10 represents "the worst immaginable pain"
Measured: Baseline (preoperative) and at 6, 12, 24, 48 and 72 hours after placement of the intracanal medicament.
Secondary outcomes (2)
Incidence of Postoperative pain
The percentage of patients experiencing any postoperative pain (NRS=0) within the follow-up period
Measured: Up to 72 hours after placement of intracanal medicament
Postoperative Analgesic Consumption
The total amount of prescribed analgesics consumed by the oatient. this will be measured by counting the total number of Ibuprofen 400 mg tablets taken by patients.
Measured: Up to 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start15 Dec 2025
- Primary completion15 Feb 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp Necrosis, Apical PeriodontitisStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Egyptian Russian University, Fayoum University
- Responsible party
- Principal investigator, Maha Nasr, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07603934
- Sponsor's protocol ID
- ERU2
- Status last verified
- Jul 2026
- First submitted
- 18 Nov 2025
- Last updated
- 21 Jul 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 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Postoperative Pain After Using Ibuprofen, Nitrofurantoin, or Calcium Hydroxide as Intracanal Medicaments in Root Canal Treatment of Necrotic Mandibular Posterior Teeth. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07603934
- Acronym / sponsor ID
- ERU2
- Conditions
- Pulp Necrosis, Apical Periodontitis
- Keywords
- Necrotic Pulp
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Egyptian Russian University, Fayoum University
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 22 May 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 aim of this study is to assess the effect of ibuprofen, nitrofurantoin, and calcium hydroxide on postoperative pain after endodontic treatment of necrotic mandibular posterior teeth
Research question/hypothesis:
In patients with necrotic pulps in their mandibular posterior teeth, there would be no difference in the incidence and/or severity of postoperative pain after the use of ibuprofen, nitrofurantoin, or calcium hydroxide intracanal medications.
The study will evaluate postoperative pain after using either of the tested drugs as an intracanal medication amidst visits. of endodontic treatment in cases where pulp necrosis is confirmed.
Detailed description
- Trial design:
- A Randomized controlled, double-blind, parallel-arm, clinical trial.
- Allocation ratio 1:1:1
- Framework: superiority
- Study settings:
Outpatient clinic of Endodontics at the Faculty of Dentistry, Egyptian Russian University, Badr city, Cairo governorate, Egypt.
- Eligibility criteria
- Inclusion criteria:
- Patients with necrotic pulps.
- Adult, healthy patients, older than 18 years old
- Males and females.
- Patient with the ability to understand and use pain scales.
- Patient who accepts enroll to the study.
- Exclusion criteria:
- Patients' allergies or any other contraindication to any of the medications used.
- Pregnant and lactating females.
- Patients have been taking pain medication 12 hours earlier.
- Patients who have more than one symptomatic mandibular tooth in the same quadrant.
- Patients with contributory medical history (ASA>II).
- Diagnosis:
The diagnosis of pulp necrosis is confirmed through the patients' history, lack of response to cold testing and negative response to electric pulp tester whenever .The treatment will be done on two- visits.
- Treatment procedure: Each patient will be given an NRS chart to rate her /his presenting pain as preoperative pain. After complete mechanical preparation, each patient will be randomly assigned to either of three groups as follows, group 1: ibuprofen will be used as an intracanal medication, group 2: nitrofurantoin will be used as an intra canal medication and group 3: CaOH will be used as an intracanal medicament. The access cavity will be then sealed with temporary filling (MD-TEMP, META BIOMED CO., LTD. Chungbuuk, Korea). Post-operative instructions and appropriate post-operative rescue medication will be prescribed (400mg Ibuprofen). All patients will be asked to record their postoperative pain level felt on NRS at 6, 12, 24, 48, 72 hours and 7 days.
One week after the first visit, patients will be recalled to the clinic to complete their root canal treatment as recommended. All canals will be dried then obturated by the modified single cone technique using 0.04 taper gutta percha points and epoxy resin sealer. Patients will be referred to an operative or a fixed prosthodontics specialist for crown placement at the Faculty of Dentistry, Egyptian Russian University.
Research objective (state the aim) The aim of this study is to assess the effect of ibuprofen, nitrofurantoin and calcium hydroxide on postoperative pain after endodontic treatment of necrotic mandibular posterior teeth.
Sample size: (if calculation equation is used please state) A total of 111 patients, 37 per group needed for the clinical trial was calculated
Grouping \& Randomization used:(specify if present) Three groups Group 1: ibuprofen Group 2: nitrofurantoin Group 3: calcium hydroxide
Outcome variables:
The primary outcome the effect of ibuprofen, nitrofurantoin and calcium hydroxide on postoperative pain after endodontic treatment of necrotic mandibular posterior teeth.
Postoperative pain will be measured using NRS at 6, 12, 24, 48, 72 hours postoperatively. Numerical Rating Scale (NRS) (20): It is an 11-point scale consisting of numbers from 0 through 10; - 0 reading represents "no pain" - 1-3 readings represent "mild pain" - 4- 6 readings represent "moderate pain" - 7- 10 readings represent "severe pain"
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ibuprofen | Experimental | Drug: ibuprofenIbuprofen. a NSAID, will be ground and formed into a paste to be placed inside the root canals of necrotic mandibular posterior teeth, to explore its effects on post-operative pain |
| nitrofurantoin | Experimental | Drug: Nitrofurantoin |
| calcium hydroxide | Active comparator | Drug: Calcium Hydroxide |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients with necrotic pulps.
- Adult, healthy patients, older than 18 years old
- Males and females.
- Patient with the ability to understand and use pain scales.
- Patient who accepts enroll to the study.
Key exclusion criteria (5 listed)
- Patients' allergies or any other contraindication to any of the medications used.
- Pregnant and lactating females.
- Patients have been taking pain medication 12 hours earlier.
- Patients who have more than one symptomatic mandibular tooth in the same quadrant.
- Patients with contributory medical history (ASA>II).
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 |
|---|---|---|
| ibuprofenIbuprofen. a NSAID, will be ground and formed into a paste to be placed inside the root canals of necrotic mandibular posterior teeth, to explore its effects on post-operative pain | Drug | ibuprofen |
| NitrofurantoinNitrofurantoin tablets will be formed into a paste to be placed inside the root canals of necrotic mandibular premolars during endodontic treatment. | Drug | nitrofurantoin |
| Calcium HydroxideCalcium Hydroxide intracanal medicament will be placed inside the root canals of mandibular necrotic posterior teeth during endodontic treatment. | Drug | calcium hydroxide |
Primary outcome
Intensity of Postoperative pain
Time frame: Baseline (preoperative) and at 6, 12, 24, 48 and 72 hours after placement of the intracanal medicament.
Postoperative pain intensity will be self-reported by patients using an 11-point Numerical rating scale (NRS), where 0 represents "no paon" and 10 represents "the worst immaginable pain"
2 secondary outcomes
Incidence of Postoperative pain
Time frame: Up to 72 hours after placement of intracanal medicament
Postoperative Analgesic Consumption
Time frame: Up to 72 hours postoperatively
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 Jul 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.
Faculty of Oral and Dental Medicine, Egyptian Russian University
Cairo, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ibuprofen, Nitrofurantoin and Calcium Hydroxide in people with Pulp Necrosis, Apical Periodontitis, 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 5 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: looking for participants now, as of the sponsor's last update on 21 Jul 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Intensity of Postoperative pain (time frame: Baseline (preoperative) and at 6, 12, 24, 48 and 72 hours after placement of the intracanal medicament.). 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 Jul 2026.