Clinical trial NCT05074628: Effect of Nitrofurantion Used as an Intracanal Medicament
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Intracanal Medication
Keywords: Nitrofurantion
necrotic pulp
Calcium Hydroxide
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-10-12
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Postoperative pain
timeFrame: 2 Weeks
Secondary outcomes:
measure: Bacterial load reduction
timeFrame: 2 Weeks
measure: Incidence of inter-appointment flare up
timeFrame: 2 Weeks
measure: Incidence of analgesic intake
timeFrame: 2 Weeks
Other outcomes:
Locations:
Study officials:
References:
citation: 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.