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Bupivacaine Lozenge vs Lidocaine Injection for Periodontitis Pain
NCT01878864Phase 2
Key facts
- Status
- Terminated
- Start
- Nov 2012
- Primary completion
- Jun 2013
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- bupivacaine
- Conditions
- periodontitis
01
Overview
Phase 2, randomised, open-label trial of bupivacaine in periodontitis (2 arms). Primary endpoints: Visual Analog Scale for Pain at Day 1 and Visual Analog Scale for Discomfort at Day 1. Started Nov 2012; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Bupivacaine lozenge
Single dose administration of a 25 mg bupivacaine lozenge before scaling and root planning.
Lidocaine-adrenalin injection
Lidocaine-adrenalin injection administered by the dentist.
03
Who it enrols
Adult patients with periodontitis undergoing scaling and root planning, excluding those with allergies to amide anesthetics, other gingival infections, or pregnancy/breastfeeding.
04
Endpoints
Primary
Visual Analog Scale for Pain
Visual Analog Scale for Discomfort
Secondary
Investigator evaluation of the scaling procedure
Patient assessment of the pharmaceutical formulations
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