The Effect of Different Intra-canal Medications on Postoperative Pain

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-40
SponsorCairo University

About this trial

The aim of this study is to assess the effect of ibuprofen, nitrofurantoin, and calcium hydroxide on postoperative pain after endodontic treatment of necrotic mandibular posterior teeth

Research question/hypothesis:

In patients with necrotic pulps in their mandibular posterior teeth, there would be no difference in the incidence and/or severity of postoperative pain after the use of ibuprofen, nitrofurantoin, or calcium hydroxide intracanal medications.

The study will evaluate postoperative pain after using either of the tested drugs as an intracanal medication amidst visits. of endodontic treatment in cases where pulp necrosis is confirmed.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients with necrotic pulps.

Adult, healthy patients, older than 18 years old

Males and females.

Patient with the ability to understand and use pain scales.

Disqualifiers

Patients' allergies or any other contraindication to any of the medications used.

Pregnant and lactating females.

Patients have been taking pain medication 12 hours earlier.

Patients who have more than one symptomatic mandibular tooth in the same quadrant.

Trial design

Design model

Parallel

Treatments tested in this trial

  • ibuprofen

    Drug

    Ibuprofen. a NSAID, will be ground and formed into a paste to be placed inside the root canals of necrotic mandibular posterior teeth, to explore its effects on post-operative pain

  • Nitrofurantoin

    Drug

    Nitrofurantoin tablets will be formed into a paste to be placed inside the root canals of necrotic mandibular premolars during endodontic treatment.

  • Calcium Hydroxide

    Drug

    Calcium Hydroxide intracanal medicament will be placed inside the root canals of mandibular necrotic posterior teeth during endodontic treatment.

Treatment groups

111 Participants
are divided into 3 treatment groups
Group A: ibuprofenExperimental treatment 1 intervention
Group B: nitrofurantoinExperimental treatment 1 intervention
Group C: calcium hydroxideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Intensity of Postoperative pain

Postoperative pain intensity will be self-reported by patients using an 11-point Numerical rating scale (NRS), where 0 represents "no paon" and 10 represents "the worst immaginable pain"

Time frame
Baseline (preoperative) and at 6, 12, 24, 48 and 72 hours after placement of the intracanal medicament.

Secondary outcomes

1

Incidence of Postoperative pain

The percentage of patients experiencing any postoperative pain (NRS=0) within the follow-up period

Time frame
Up to 72 hours after placement of intracanal medicament
2

Postoperative Analgesic Consumption

The total amount of prescribed analgesics consumed by the oatient. this will be measured by counting the total number of Ibuprofen 400 mg tablets taken by patients.

Time frame
Up to 72 hours postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cairo University

Lead sponsor

Egyptian Russian University

Collaborator

Fayoum University

Collaborator