Intracanal MedicationEarly Phase 1NCT05074628
Effect of Nitrofurantion Used as an Intracanal Medicament
A Early Phase 1 study testing Nitrofurantoin capsules in people with Intracanal Medication, run by Cairo University.
Trial summary
The aim of this study is to clinically evaluate the effect of Nitrofurantion on Intensity of Postoperative Pain and Bacterial Load Reduction, when compared to calcium hydroxide in teeth with necrotic pulp. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Intracanal Medication
- What is being tested?
- Nitrofurantoin capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 1 Dec 2023
- Phase
- Early Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1- Age between 18-50 years old. 2-Males or females. 3-Healthy patients whom are categorized as I or II according to The American Society of Anesthesiologists. (ASA I or II) 4-Patients' accepting to participate in the trial. 5-Patients who can understand pain scale and can sign the informed consent. 6- Mandibular Single rooted premolars, having single root canal:
- Diagnosed clinically with pulp necrosis.
- Absence of spontaneous pain
- Slight widening in the periodontal membrane space or with periapical radiolucency not exceeding 2*2 mm radiographically.
- Normal occlusal contact with opposing teeth.
Who cannot join
- 1- Medically compromised patients having significant systemic disorders (ASA III or IV).
- 2-If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively as it might alter their pain perception.
- 3-Pregnant women: to avoid radiation exposure, anaesthesia, medication and hormonal Fluctuation that might increase pain prevalence.
- 4-Patients reporting bruxism, clenching, TMJ problems or traumatic occlusion: to avoid further pressure on inflamed tooth which induce subsequent irritation and inflammation.
- 5-Patients with two or more adjacent teeth requiring endodontic treatment. 6- Teeth that requires further procedural steps or multidisciplinary approach, which is out of this experiment's scope: i.Association with swelling or fistulous tract. ii. Acute periapical abscess. iii. Mobility Grade II or III. iv. Pocket depth more than 5mm. v. Previous root canal treatment. vi. Non-restorable. vii. Immature root. Vii. Radiographic evidence of external or internal root resorption, vertical root fracture, perforation, calcification.
- 7-Inability to perceive the given instructions.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Nitrofurantion Used as an Intracanal Medicament on the Intensity of Postoperative Pain and Bacterial Load Reduction Versus Calcium Hydroxide in Teeth With Necrotic Pulp: A Randomized Clinical Trial
The aim of this study is to clinically evaluate the effect of Nitrofurantion on Intensity of Postoperative Pain and Bacterial Load Reduction, when compared to calcium hydroxide in teeth with necrotic pulp.
Read the detailed description
Nitrofurantoin has been used as a treatment for UTI since the 1950s. Evidence suggested that nitrofurantoin has excellent safety profile and lower resistance rates compared to recently introduced antimicrobials, recommending it as the first-line agent. Nitrofurantoin is convert to reactive intermediates by bacterial Nitroreductases. These intermediates were shown to attack bacterial ribosomal proteins non-specifically, causing complete inhibition of protein synthesis. In MIC, Nitrofurantoin specifically inhibit enzyme synthesis in bacteria (24). The lack of clinically significant bacterial resistance development to Nitrofurantoin is likely due to the multiple sites of attack and multiple mechanisms of action. Achievement of high local levels and low serum concentrations, and its effectiveness against both gram-negative and gram-positive bacteria provide many advantages that many of the newer agents do not have. After searching the database there is no clinical studies found yet on the effect of Nitrofurantoin antibiotic used as intracanal medicament in teeth with necrotic pulp. The aim of this study is to clinically evaluate the effect of Nitrofurantion on Intensity of Postoperative Pain and Bacterial Load Reduction, when compared to calcium hydroxide in teeth with necrotic pulp.
- Conditions
- Intracanal Medication
- Being tested
- Nitrofurantoin capsules
- Keywords
- Nitrofurantion, necrotic pulp, Calcium Hydroxide
- Medical subject headings
- Dental Pulp Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrofurantoin capsulesDrug
methyl cellulose powder (MC) will be added to Nit solution to get a thick paste like consistency mixture.
| Study group | Role | What they receive |
|---|---|---|
| Nitrofurantion | Experimental | is the drug of choice for the treatment of infections caused by multidrug resistant pathogens. Receives: Drug: Nitrofurantoin capsules |
| Calcium Hydroxide | Active comparator | Most commonly used intracanal medicaments . Antimicrobial activity of calcium hydroxide is related to the release of hydroxyl ions in an aqueous environment. Receives: Drug: Nitrofurantoin capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
measured using numerical rating scale (NRS), 6, 12, 24, 48 hours:
Measured: 2 Weeks
Secondary outcomes (3)
Bacterial load reduction
determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml).
Measured: 2 Weeks
Incidence of inter-appointment flare up
measured using visual analog scale of postoperative swelling (VAS).
Measured: 2 Weeks
Incidence of analgesic intake
numerical counting.
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start1 Dec 2021 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracanal MedicationStudies 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
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mohamed Elsaber, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05074628
- Sponsor's protocol ID
- ICM
- Status last verified
- Oct 2021
- First submitted
- 2 Oct 2021
- Last updated
- 12 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Alrahman MSA, Faraj BM, Dizaye KF. Assessment of Nitrofurantoin as an Experimental Intracanal Medicament in Endodontics. Biomed Res Int. 2020 Feb 18;2020:2128473. doi: 10.1155/2020/2128473. eCollection 2020.
PubMed 32149086
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Nitrofurantion Used as an Intracanal Medicament on the Intensity of Postoperative Pain and Bacterial Load Reduction Versus Calcium Hydroxide in Teeth With Necrotic Pulp: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05074628
- Acronym / sponsor ID
- ICM
- Conditions
- Intracanal Medication
- Keywords
- Nitrofurantion, necrotic pulp, Calcium Hydroxide
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 12 Oct 2021 (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 clinically evaluate the effect of Nitrofurantion on Intensity of Postoperative Pain and Bacterial Load Reduction, when compared to calcium hydroxide in teeth with necrotic pulp.
Detailed description
Nitrofurantoin has been used as a treatment for UTI since the 1950s. Evidence suggested that nitrofurantoin has excellent safety profile and lower resistance rates compared to recently introduced antimicrobials, recommending it as the first-line agent. Nitrofurantoin is convert to reactive intermediates by bacterial Nitroreductases. These intermediates were shown to attack bacterial ribosomal proteins non-specifically, causing complete inhibition of protein synthesis. In MIC, Nitrofurantoin specifically inhibit enzyme synthesis in bacteria (24). The lack of clinically significant bacterial resistance development to Nitrofurantoin is likely due to the multiple sites of attack and multiple mechanisms of action. Achievement of high local levels and low serum concentrations, and its effectiveness against both gram-negative and gram-positive bacteria provide many advantages that many of the newer agents do not have. After searching the database there is no clinical studies found yet on the effect of Nitrofurantoin antibiotic used as intracanal medicament in teeth with necrotic pulp. The aim of this study is to clinically evaluate the effect of Nitrofurantion on Intensity of Postoperative Pain and Bacterial Load Reduction, when compared to calcium hydroxide in teeth with necrotic pulp.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nitrofurantion | Experimental | Drug: Nitrofurantoin capsulesis the drug of choice for the treatment of infections caused by multidrug resistant pathogens. |
| Calcium Hydroxide | Active comparator | Drug: Nitrofurantoin capsulesMost commonly used intracanal medicaments . Antimicrobial activity of calcium hydroxide is related to the release of hydroxyl ions in an aqueous environment. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 1- Age between 18-50 years old. 2-Males or females. 3-Healthy patients whom are categorized as I or II according to The American Society of Anesthesiologists. (ASA I or II) 4-Patients' accepting to participate in the trial. 5-Patients who can understand pain scale and can sign the informed consent. 6- Mandibular Single rooted premolars, having single root canal:
Key exclusion criteria (6 listed)
- 1- Medically compromised patients having significant systemic disorders (ASA III or IV).
- 2-If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively as it might alter their pain perception.
- 3-Pregnant women: to avoid radiation exposure, anaesthesia, medication and hormonal Fluctuation that might increase pain prevalence.
- 4-Patients reporting bruxism, clenching, TMJ problems or traumatic occlusion: to avoid further pressure on inflamed tooth which induce subsequent irritation and inflammation.
- 5-Patients with two or more adjacent teeth requiring endodontic treatment. 6- Teeth that requires further procedural steps or multidisciplinary approach, which is out of this experiment's scope: i.Association with swelling or fistulous tract. ii. Acute periapical abscess. iii. Mobility Grade II or III. iv. Pocket depth more than 5mm. v. Previous root canal treatment. vi. Non-restorable. vii. Immature root. Vii. Radiographic evidence of external or internal root resorption, vertical root fracture, perforation, calcification.
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 |
|---|---|---|
| Nitrofurantoin capsulesmethyl cellulose powder (MC) will be added to Nit solution to get a thick paste like consistency mixture. | Drug | Calcium Hydroxide, Nitrofurantion |
Primary outcome
Postoperative pain
Time frame: 2 Weeks
measured using numerical rating scale (NRS), 6, 12, 24, 48 hours:
3 secondary outcomes
Bacterial load reduction
Time frame: 2 Weeks
Incidence of inter-appointment flare up
Time frame: 2 Weeks
Incidence of analgesic intake
Time frame: 2 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2021.
- Background: PubMed 32149086Alrahman MSA, Faraj BM, Dizaye KF. Assessment of Nitrofurantoin as an Experimental Intracanal Medicament in Endodontics. Biomed Res Int. 2020 Feb 18;2020:2128473. doi: 10.1155/2020/2128473. eCollection 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Intracanal Medication
Recruiting
Modulation of Periapical Inflammation Following Nano-sized Intracanal Medication. A Randomized Controlled Clinical Trial
Post-operative Pain, Periapical Inflammation
Recruiting
Removal of Intracanal Medicaments by Different Techniques Using Cone Beam Computed Tomography Analysis
Removal of Intracanal Medication
Recruiting
Postoperative Pain and Substance P Levels After Bioceramic vs Calcium Hydroxide Intracanal Medicaments in Symptomatic Apical Periodontitis
Symptomatic Apical Periodontitis
Recruiting
Efficiency of Asiaticoside as Intracanal Medication in Revascularization Process
Immature Permanent Teeth With Open Apex, Pulp Necrosis
Active, not recruitingPhase 2
Evaluation of Postoperative Pain and Bacterial Load After Hyalone or Calcium Hydroxide Medication in Mandibular First Molars
Bacterial Load Reduction, Postoperative Pain
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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nitrofurantoin capsules in people with Intracanal Medication, run by Cairo University.
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 6 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 12 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Noha M Elsaber, Master (00201157157197, nohaalsaber@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 2 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05074628, which also lists 1 linked publication.
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 12 Oct 2021.