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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Asymptomatic Necrotic Teeth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control: Calcium Hydroxide

Non-setting Calcium Hydroxide

Group Type NO_INTERVENTION

No interventions assigned to this group

Test: Triple Antibiotic Paste and Anti-Inflammatory Drug

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

Group Type OTHER

triple antibiotic paste with an anti-inflammatory drug

Intervention Type OTHER

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

Interventions

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triple antibiotic paste with an anti-inflammatory drug

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes