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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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05074628
Enrollment
38
Registered
2021-10-12
Start date
2021-12-01
Completion date
2023-12-01
Last updated
2021-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracanal Medication

Keywords

Nitrofurantion, necrotic pulp, Calcium Hydroxide

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.

Interventions

methyl cellulose powder (MC) will be added to Nit solution to get a thick paste like consistency mixture.

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Postoperative pain2 Weeksmeasured using numerical rating scale (NRS), 6, 12, 24, 48 hours:

Secondary

MeasureTime frameDescription
Bacterial load reduction2 Weeksdetermined by bacterial counting using agar culture technique after root canal preparation (CFU/ml).
Incidence of inter-appointment flare up2 Weeksmeasured using visual analog scale of postoperative swelling (VAS).
Incidence of analgesic intake2 Weeksnumerical counting.

Contacts

Primary ContactNoha M Elsaber, Master
nohaalsaber@dentistry.cu.edu.eg00201157157197

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026