NCT01878864

Effect of Local Anesthesia in Patients With Marginal Periodontitis Undergoing Scaling and Root Planning

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Ove Andersen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A randomised cross-over study comparing two methods of local anaesthesia for patients diagnosed with periodontitis undergoing scaling and root planning. 40 patients will be included in the study, which aims to demonstrate that the effect of a bupivacaine lozenge is non-inferior to lidocaine-adrenalin injections.

Detailed description

40 periodontitis patients undergoing scaling and root planning (SRP) will be randomised to receive local anaesthesia by either a bupivacaine lozenge or lidocaine-adrenalin injection at their first visit. At the following visit, the patients will receive the opposite treatment. At each visit the patient will evaluate pain before, during and after SRP by: * Visual Analog Scale (VAS) 0-10 where 0 = no pain, 10 = extreme pain. * McGills Pain Questionnaire (MPQ), which gives a qualitative pain profile. At each visit the patient will evaluate discomfort before, during and after the SRP by: \- Visual Analog Scale (VAS) 0-10 where 0 = no discomfort, 10 = extreme discomfort. Additionally the patient assesses the comfort of administration of the two local anaesthesia as well as the taste of the bupivacaine lozenge. The investigator also evaluates the scaling procedure.

Conditions

• Pain and Discomfort During Scaling and Root Planning of Patients With
• Periodontitis

Interventions

Type	Name	Description
DRUG	Bupivacaine lozenge
DRUG	Lidocaine-adrenalin injection

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2013-06-17
• Last updated: 2015-04-03

Locations

3 sites across 1 country: Denmark