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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pain and Discomfort During Scaling and Root Planning of Patients With, Periodontitis

Intervention / Treatment
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* Drug: Bupivacaine lozenge
* Drug: Lidocaine-adrenalin injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bupivacaine lozenge<br>Single dose administration of a 25 mg bupivacaine lozenge before the scaling and root planning was performed. | Drug: Bupivacaine lozenge<br> <br> |
| Active Comparator: Lidocaine-adrenalin injection<br>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. | Drug: Lidocaine-adrenalin injection<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Pain and discomfort are measured immediately after the scaling and root planning procedure Level of pain: -Visual Analog Scale (VAS) 0-10 where 0 = no pain, 10 = extreme pain | Day 1 | 
| 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. | 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 | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator evaluation of the scaling procedure | After the scaling and root planning the investigator evaluates the scaling procedure by a questionnaire | Day 1 | 
| Patient assessment of the two pharmaceutical formulations | After the scaling procedure the patient assesses the two pharmaceutical formulations by a questionnaire | Day 1 | 
| 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. | Pain and discomfort are measured immediately after the scaling and root planning procedure Level of pain: -McGills Pain Questionnaire (MPQ), which gives a qualitative pain profile | Daiy 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Discomfort, Periodontitis, Scaling and Root Planning, Visual Analogue Scale, McGills Pain Questionnaire