Phase 1
N=84
Effect of Triple Antibiotic Paste as an Intracanal Medication With an Anti-Inflammatory Drug on Post-operative Pain.
Asymptomatic Necrotic Teeth
Bottom Line
View on ClinicalTrials.gov: NCT02907489 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Post Operative Pain — 3.18; 2.27; 2.20; 1.39 score on a scale — p=0.083
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- triple antibiotic paste with an anti-inflammatory drug (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cairo University
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post Operative Pain |
3.18; 2.27; 2.20; 1.39; 1.30; 0.78 | 0.083 |
| SECONDARY Intracanal Bacterial Count |
3.84; 3.85; 3.63; 3.36; 2.14; 1.33 | 0.982 |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02907489). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.