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

Cairo University (CU)

Status and phase: Completed; Phase 1

Conditions: Asymptomatic Necrotic Teeth

Treatments: Other: triple antibiotic paste with an anti-inflammatory drug

Study type: Interventional

Funder types: Other

Identifiers

NCT02907489

CEBD-CU-2016-09-194

Details and patient eligibility

About

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.

Full 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.

Enrollment: 84 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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84 participants in 2 patient groups

Control: Calcium Hydroxide

No Intervention group

Description:

Non-setting Calcium Hydroxide

Test: Triple Antibiotic Paste and Anti-Inflammatory Drug

Other group

Description:

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

Treatment:

Other: triple antibiotic paste with an anti-inflammatory drug