Effect of Preoperative Clindamycin on Postoperative Endodontic Pain

NCT ID: NCT03033472

Last Updated: 2017-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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

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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

Conditions

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Symptomatic Periapical Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Study Groups

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Clindamycin

600 mg of Clindamycin orally 30 minutes before root canal treatment

Group Type EXPERIMENTAL

600 mg Clindamycin orally

Intervention Type DRUG

600 mg Clindamycin orally 30 minutes before treatment

Placebo

placebo 30 minutes Orally before treatment

Group Type PLACEBO_COMPARATOR

Oral Placebo

Intervention Type DRUG

Oral Placebo 30 minutes before treatment

Interventions

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600 mg Clindamycin orally

600 mg Clindamycin orally 30 minutes before treatment

Intervention Type DRUG

Oral Placebo

Oral Placebo 30 minutes before treatment

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Nermeen Saeed Abdel Ghany El Sedawy

principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nermeen SA El Sedawy, Post Graduate

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Suzan AW Wanees, PhD

Role: STUDY_CHAIR

Cairo Univertsity

Shaimaa Gawdat, PhD

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

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Nermeen SA El Sedawy, Post Graduate

Role: CONTACT

01002463414

References

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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.

Reference Type RESULT
PMID: 24967571 (View on PubMed)

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.

Reference Type RESULT
PMID: 16343114 (View on PubMed)

Other Identifiers

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CEBC-CU-2017-01-09

Identifier Type: -

Identifier Source: org_study_id

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