Symptomatic Periapical Periodontitis
Conditions
Brief summary
The aim of this prospective, randomized, placebo controlled study is to evaluate the effect of a single preoperative dose of amoxicillin/clavulanic acid combination on post-operative pain and swelling in adult patient with symptomatic apical periodontitis.
Detailed description
Medical and dental history will be obtained from all patients participating in this trial. Clinical and radiographic evaluation for each tooth included in this study will be recorded. Clinical diagnosis of symptomatic apical periodontitis is to be confirmed. Prior to initiation of root canal treatment, eligible participants will be randomly assigned to one of the following groups: experimental group (receiving 2 gm of amoxicillin/ clavulanic acid orally 30 minutes before the treatment) or control group (receiving a placebo 30 minutes before treatment). Root canal treatment will then be carried out in a single visit. Each patient will receive a 7-day diary to record postoperative pain and swelling. In case of pain, the participant will be instructed to take an analgesic. Post-operative pain will be measured as a primary outcome on 11-point scale (NRS) at the following time points: 6, 12, 24, 48, 72 hours and 7 days. The occurrence of swelling will be reported by participant as a secondary outcome.
Interventions
2 gm of amoxicillin/ clavulanic acid combination orally 30 minutes before root canal treatment
DRUGOral placebo
placebo 30 minutes before root canal treatment
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patients with symptomatic apical periodontitis who do not have evidence of spreading infection or systemic involvement. * Mandibular posterior teeth. * Patients with non-contributory systemic condition. * Patients who can understand pain scales and able to sign informed consent.
Exclusion criteria
* Patients allergic to penicillin. * Patients who have a draining sinus tract. * Retreatment cases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | Up to 7 days after endodontic treatment | Postoperative pain will be measured by a numerical rating scale (NRS). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Swelling | Up to 7 days after endodontic treatment | The occurrence of Swelling will be measured by a questionnaire. |
Countries
Egypt
Outcome results
None listed