Clinical trial NCT03033472: Effect of Preoperative Clindamycin on Postoperative Endodontic Pain
Official title: Effect of Preoperative Single-dose Clindamycin on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Symptomatic Periapical Periodontitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-01-26
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this prospective, randomized, placebo controlled study is to evaluate the effect of clindamycin 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.

Before root canal treatment, eligible participants will be randomly assigned to one of the following groups: experimental group (taking 600 mg of clindamycin orally) or control group (taking placebo ) 30 minutes before the start of the treatment. Single-visit root canal treatment will be performed.

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

Eligibility criteria: Inclusion Criteria:

1. Patients with symptomatic apical periodontitis and do not have evidence of spreading infection or systemic involvement.
2. Mandibular posterior teeth.
3. Patients in good health.
4. Patients who can understand pain scales (NRS).
5. Patients able to sign informed consent.

Exclusion Criteria:

1. Patients who have draining sinus tract.
2. Retreatment cases
3. Patients with weeping canals.

Primary outcomes:
measure: Post-operative pain
timeFrame: Up to 7 days after endodontic treatment
Secondary outcomes:
measure: Swelling
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Nermeen SA El Sedawy, Post Graduate
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo Univertsity
name: Suzan AW Wanees, PhD
role: STUDY_CHAIR
affiliation: Cairo University
name: Shaimaa Gawdat, PhD
role: STUDY_DIRECTOR
References:
citation: Cope A, Francis N, Wood F, Mann MK, Chestnutt IG. Systemic antibiotics for symptomatic apical periodontitis and acute apical abscess in adults. Cochrane Database Syst Rev. 2014 Jun 26;(6):CD010136. doi: 10.1002/14651858.CD010136.pub2.
citation: Lindeboom JA, Frenken JW, Valkenburg P, van den Akker HP. The role of preoperative prophylactic antibiotic administration in periapical endodontic surgery: a randomized, prospective double-blind placebo-controlled study. Int Endod J. 2005 Dec;38(12):877-81. doi: 10.1111/j.1365-2591.2005.01030.x.