Pain and Discomfort During Scaling and Root Planning of Patients With, Periodontitis
Conditions
Keywords
Pain, Discomfort, Periodontitis, Scaling and Root Planning, Visual Analogue Scale, McGills Pain Questionnaire
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.
Interventions
DRUGLidocaine-adrenalin injection
Sponsors
Ove Andersen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Day 1 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator evaluation of the scaling procedure | Day 1 | After the scaling and root planning the investigator evaluates the scaling procedure by a questionnaire |
| Patient assessment of the two pharmaceutical formulations | Day 1 | After the scaling procedure the patient assesses the two pharmaceutical formulations by a questionnaire |
| 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 | 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 |
Countries
Denmark
Outcome results
None listed