Effect of Preoperative Clindamycin on Postoperative Endodontic Pain

Symptomatic Periapical Periodontitis Clinical Trial

Official title:

Effect of Preoperative Single-dose Clindamycin on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03033472
• Other study ID #: CEBC-CU-2017-01-09
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: January 24, 2017
• Last updated: January 26, 2017

Study information

• Verified date: January 2017
• Source: Cairo University
• Contact: Nermeen SA El Sedawy, Post Graduate
• Phone: 01002463414
• Email: nermeen.elsedaway[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periapical Periodontitis
• Periodontitis
• Symptomatic Periapical Periodontitis

Intervention

Drug:
• 600 mg Clindamycin orally
600 mg Clindamycin orally 30 minutes before treatment
• Oral Placebo
Oral Placebo 30 minutes before treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

References & Publications (2)

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. Review. — View 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):877-8 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative pain	Post-operative pain will be measured by a numerical rating scale (NRS)	Up to 7 days after endodontic treatment
Secondary	Swelling	The occurrence of Swelling will be measured by a questionnaire	7 days