Effect of Local Anesthesia in Patients With Marginal Periodontitis Undergoing Scaling and Root Planning
Overview
- Phase
- Phase 2
- Intervention
- Bupivacaine lozenge
- Conditions
- Pain and Discomfort During Scaling and Root Planning of Patients With
- Sponsor
- Ove Andersen
- Enrollment
- 12
- Locations
- 3
- Primary Endpoint
- To demonstrate a non-inferior effect on pain and discomfort during scaling and root planning by a bupivacaine lozenge in comparison to lidocaine-adrenalin injections.
- Status
- Terminated
- Last Updated
- 11 years ago
Overview
Brief 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.
Investigators
Ove Andersen
MD
Hvidovre University Hospital
Eligibility Criteria
Inclusion Criteria
- •Patients diagnosed as having, respectively periodontitis marginalis adulta progressiva lenta and periodontitis marginalis adulta progressiva rapid in the hygiene phase, where depurations are repeated within a short timeframe
- •Age between 18 and 80 years
- •Ability to speak, read and understand danish
- •Ability to give oral and written consent
Exclusion Criteria
- •Known allergy to bupivacaine or other local anaesthetics of the amide type
- •Other gingival infections (eg lichen planus)
- •Pregnancy -if in doubt a pregnancy test will be made
- •Breastfeeding
Arms & Interventions
Bupivacaine lozenge
Single dose administration of a 25 mg bupivacaine lozenge before the scaling and root planning was performed.
Intervention: Bupivacaine lozenge
Lidocaine-adrenalin injection
Xyloplyin Dental Adrenalin (20 mg/ml lidocaine, 12.5 microgram/ml adrenaline). Frequency and duration of injections was decided by the dentist preforming the scaling and root planning.
Intervention: Lidocaine-adrenalin injection
Outcomes
Primary Outcomes
To demonstrate a non-inferior effect on pain and discomfort during scaling and root planning by a bupivacaine lozenge in comparison to lidocaine-adrenalin injections.
Time Frame: Day 1
Pain and discomfort are measured immediately after the scaling and root planning procedure Level of discomfort: -Visual Analog Scale (VAS) 0-10 where 0 = no discomfort, 10 = extreme discomfort
Secondary Outcomes
- To demonstrate a non-inferior effect on pain and discomfort during scaling and root planning by a bupivacaine lozenge in comparison to lidocaine-adrenalin injections.(Daiy 1)
- Investigator evaluation of the scaling procedure(Day 1)
- Patient assessment of the two pharmaceutical formulations(Day 1)