Asymptomatic Necrotic Teeth
Conditions
Keywords
post operative pain, triple antibiotic paste, intracanal medication
Brief 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.
Detailed 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.
Interventions
OTHERtriple antibiotic paste with an anti-inflammatory drug
Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast)
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Intracanal Bacterial Count | 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) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control: Calcium Hydroxide non setting calcium hydroxide | 42 |
| Test: Triple Antibiotic Paste and Anti-Inflammatory Drug Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast) | 42 |
| Total | 84 |
Baseline characteristics
| Characteristic | Control: Calcium Hydroxide | Test: Triple Antibiotic Paste and Anti-Inflammatory Drug | Total |
|---|---|---|---|
| Age, Continuous | 32.23 years STANDARD_DEVIATION 9.75 | 32.32 years STANDARD_DEVIATION 9.65 | 32.28 years STANDARD_DEVIATION 9.7 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 16 Participants | 22 Participants | 38 Participants |
| Sex: Female, Male Male | 26 Participants | 20 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 41 |
| other Total, other adverse events | 0 / 40 | 0 / 41 |
| serious Total, serious adverse events | 0 / 40 | 0 / 41 |
Outcome results
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 \[8-10\] )
Time frame: after 24, 48, and 72 hour from the end of the first visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control: Calcium Hydroxide | Post Operative Pain | 24 hrs | 3.18 score on a scale | Standard Deviation 2.37 |
| Control: Calcium Hydroxide | Post Operative Pain | 48 hrs | 2.20 score on a scale | Standard Deviation 2 |
| Control: Calcium Hydroxide | Post Operative Pain | 72 hrs | 1.30 score on a scale | Standard Deviation 1.36 |
| Test: Triple Antibiotic Paste and Anti-Inflammatory Drug | Post Operative Pain | 24 hrs | 2.27 score on a scale | Standard Deviation 2.28 |
| Test: Triple Antibiotic Paste and Anti-Inflammatory Drug | Post Operative Pain | 48 hrs | 1.39 score on a scale | Standard Deviation 1.46 |
| Test: Triple Antibiotic Paste and Anti-Inflammatory Drug | Post Operative Pain | 72 hrs | 0.78 score on a scale | Standard Deviation 1.11 |
p-value: 0.083Chi-squared
p-value: 0.041Chi-squared
p-value: 0.063Chi-squared
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)
Time frame: before and after mechanical preparation (at day 0) and after 72 hour from placement of the intracanal medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control: Calcium Hydroxide | Intracanal Bacterial Count | S1 | 3.84 CFU/ml | Standard Deviation 1.7 |
| Control: Calcium Hydroxide | Intracanal Bacterial Count | S2 | 3.63 CFU/ml | Standard Deviation 1.63 |
| Control: Calcium Hydroxide | Intracanal Bacterial Count | S3 | 2.14 CFU/ml | Standard Deviation 1.36 |
| Test: Triple Antibiotic Paste and Anti-Inflammatory Drug | Intracanal Bacterial Count | S1 | 3.85 CFU/ml | Standard Deviation 2.01 |
| Test: Triple Antibiotic Paste and Anti-Inflammatory Drug | Intracanal Bacterial Count | S2 | 3.36 CFU/ml | Standard Deviation 1.74 |
| Test: Triple Antibiotic Paste and Anti-Inflammatory Drug | Intracanal Bacterial Count | S3 | 1.33 CFU/ml | Standard Deviation 1.39 |
p-value: 0.982Chi-squared
p-value: 0.467Chi-squared
p-value: 0.01Chi-squared