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

Asymptomatic Necrotic Teeth Clinical Trial

Official 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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02907489
• Other study ID #: CEBD-CU-2016-09-194
• Status: Completed
• Phase: Phase 1
• Start date: October 2016
• Est. completion date: July 2018

Study information

• Verified date: September 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: July 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

1. Subject's age between 18-50 years.

2. Both male and female subjects.

3. Medically free and healthy subjects.

4. Mandibular and maxillary single rooted teeth.

5. Asymptomatic non vital teeth.

Exclusion Criteria:

1. Teeth with acute dentoalveolar abscess.

2. Subjects having more than one tooth that require root canal treatment.

3. Subjects that have taken analgesic, anti-inflammatory or antibiotic drugs during the 10 days prior to the start of treatment.

4. Pregnant females.

5. Subjects with systemic diseases who have endocrine diseases, Infectious diseases or Psychological disturbance.

6. Teeth with periodontal disease or pulp calcification.

7. Subjects taking chronic pain medications.

Related Conditions & MeSH terms

• Asymptomatic Necrotic Teeth
• Necrosis
• Pain, Postoperative

Intervention

Other:
• triple antibiotic paste with an anti-inflammatory drug
Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post Operative Pain	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] )	after 24, 48, and 72 hour from the end of the first visit.
Secondary	Intracanal Bacterial Count	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)	before and after mechanical preparation (at day 0) and after 72 hour from placement of the intracanal medication.