NCT05074628

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Dec 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 2, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 12, 2021

Status Verified

October 1, 2021

Enrollment Period

1.1 years

First QC Date

October 2, 2021

Last Update Submit

October 2, 2021

Conditions

Intracanal Medication

Keywords

Nitrofurantionnecrotic pulpCalcium Hydroxide

Outcome Measures

Primary Outcomes (1)

  • Postoperative pain

    measured using numerical rating scale (NRS), 6, 12, 24, 48 hours:

    2 Weeks

Secondary Outcomes (3)

  • Bacterial load reduction

    2 Weeks

  • Incidence of inter-appointment flare up

    2 Weeks

  • Incidence of analgesic intake

    2 Weeks

Study Arms (2)

Nitrofurantion

EXPERIMENTAL

is the drug of choice for the treatment of infections caused by multidrug resistant pathogens.

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.

Drug: Nitrofurantoin capsules

Interventions

Nitrofurantoin capsulesDRUG

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

Calcium HydroxideNitrofurantion

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Medically compromised patients having significant systemic disorders (ASA III or IV).
  • If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively as it might alter their pain perception.
  • Pregnant women: to avoid radiation exposure, anaesthesia, medication and hormonal Fluctuation that might increase pain prevalence.
  • Patients reporting bruxism, clenching, TMJ problems or traumatic occlusion: to avoid further pressure on inflamed tooth which induce subsequent irritation and inflammation.
  • 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.
  • Inability to perceive the given instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 32149086BACKGROUND

MeSH Terms

Conditions

Dental Pulp Necrosis

Interventions

Nitrofurantoin

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

NitrofuransNitro CompoundsOrganic ChemicalsFuransHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Noha M Elsaber, Master

CONTACT

00201157157197nohaalsaber@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

October 2, 2021

First Posted

October 12, 2021

Study Start

December 1, 2021

Primary Completion

January 1, 2023

Study Completion

December 1, 2023

Last Updated

October 12, 2021

Record last verified: 2021-10