Effect of Nitrofurantion Used as an Intracanal Medicament

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intracanal Medication
• Intervention / Treatment: Drug: Nitrofurantoin capsules

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 Type: Interventional
• Enrollment (Anticipated): 38
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Noha M Elsaber, Master; Phone Number: 00201157157197; Email: nohaalsaber@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nitrofurantion; is the drug of choice for the treatment of infections caused by multidrug resistant pathogens.	Drug: Nitrofurantoin capsules; methyl cellulose powder (MC) will be added to Nit solution to get a thick paste like consistency mixture.
Active Comparator: Calcium Hydroxide; Most commonly used intracanal medicaments . Antimicrobial activity of calcium hydroxide is related to the release of hydroxyl ions in an aqueous environment.	Drug: Nitrofurantoin capsules; methyl cellulose powder (MC) will be added to Nit solution to get a thick paste like consistency mixture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	measured using numerical rating scale (NRS), 6, 12, 24, 48 hours:	2 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bacterial load reduction	determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml).	2 Weeks
Incidence of inter-appointment flare up	measured using visual analog scale of postoperative swelling (VAS).	2 Weeks
Incidence of analgesic intake	numerical counting.	2 Weeks

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): January 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: October 2, 2021
• First Submitted That Met QC Criteria: October 2, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 2, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Calcium Hydroxide; necrotic pulp; Nitrofurantion
• Additional Relevant MeSH Terms: Anti-Infective Agents; Anti-Bacterial Agents; Anti-Infective Agents, Urinary; Renal Agents; Nitrofurantoin
• Other Study ID Numbers: ICM (Other Identifier: BIOTRONIK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No