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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-003430-16 | EudraCT Number |
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Too slow patient inclusion and superior effect of the injection
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine lozenge | Experimental | Single dose administration of a 25 mg bupivacaine lozenge before the scaling and root planning was performed. |
|
| Lidocaine-adrenalin injection | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine lozenge | Drug |
| ||
| Lidocaine-adrenalin injection |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ove Andersen, MD | Hvidovre UH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tandlægerne Vimmelskaftet | Copenhagen K | 1161 | Denmark | |||
| Frederiksberg Tandlægerne |
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| Drug |
|
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 |
| Frederiksberg |
| 2000 |
| Denmark |
| Tandlægepraksis ved Jonna Bork | Hvidovre | 2650 | Denmark |
| ID | Term |
|---|---|
| D010146 | Pain |
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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