Effect of Triple Antibiotic Paste as an Intracanal Medication With an Anti-Inflammatory Drug on Post-operative Pain.

The purpose of this study is to determine whether the use of triple antibiotic paste as intracanal medication with an anti-inflammatory drug, compared to a calcium hydroxide will reduce postoperative pain and intracanal bacteria or not in patients with asymptomatic necrotic teeth.

Completed

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Key information

Conditions

Asymptomatic Necrotic Teeth Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

This trial is aiming to answer a clinical question whether in patients with asymptomatic necrotic teeth, the use of triple antibiotic paste as intracanal medication with an anti-inflammatory drug, compared to a calcium hydroxide, reduce postoperative pain and intracanal bacteria or not? trial design will be Randomized, controlled, double blinded, unicenter, parallel, two-arm, superiority trial with 1:1 allocation ratio.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject's age between 18-50 years.
Both male and female subjects.
Medically free and healthy subjects.
Mandibular and maxillary single rooted teeth.
Asymptomatic non vital teeth.

Exclusion criteria

Teeth with acute dentoalveolar abscess.
Subjects having more than one tooth that require root canal treatment.
Subjects that have taken analgesic, anti-inflammatory or antibiotic drugs during the 10 days prior to the start of treatment.
Pregnant females.
Subjects with systemic diseases who have endocrine diseases, Infectious diseases or Psychological disturbance.
Teeth with periodontal disease or pulp calcification.
Subjects taking chronic pain medications.

Treatment and study plan

triple antibiotic paste with an anti-inflammatory drug

Other

Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast)

Primary outcomes

Post Operative Pain

Time frame: after 24, 48, and 72 hour from the end of the first visit.

Visual Analogue Scale (VAS) of post operative pain (The VAS consisted of a 100 mm horizontal ruler without numbers except a "0" at its first part and a "10" in the last part. With "0" indicating the best outcome while "10" the worst outcome. The subjects were asked to mark the point that was equivalent to their pain intensity. The pain levels were classified as no pain [0], mild pain [1-3], moderate pain [4-7] or severe pain [8-10] )

Secondary outcomes

Intracanal Bacterial Count

Time frame: before and after mechanical preparation (at day 0) and after 72 hour from placement of the intracanal medication.

Colony forming units per milliliter of blood agar medium before root canal preparation (S1), after root canal preparation (S2) and after intracanal medication application for 72 hours (S3)

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

The Effect of Triple Antibiotic Paste as an Intracanal Medication With an Anti-Inflammatory Drug on Post-Operative Pain of Asymptomatic Uniradicular Necrotic Teeth (A Double Blind Randomized Clinical Trial).

Important dates

Study start: 2016
Primary completion: 2018
Study completion: 2018
First posted: Sep 20, 2016
Registry last updated: Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed