Clinical trial NCT01878864: Effect of Local Anesthesia in Patients With Marginal Periodontitis Undergoing Scaling and Root Planning
Official title: Effect of Local Anesthesia in Patients With Marginal Periodontitis Undergoing Scaling and Root Planning
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pain and Discomfort During Scaling and Root Planning of Patients With
Periodontitis
Keywords: Pain, Discomfort, Periodontitis, Scaling and Root Planning, Visual Analogue Scale, McGills Pain Questionnaire
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2013-06-17
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: Day 1
measure: 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.
timeFrame: Day 1
Secondary outcomes:
measure: Investigator evaluation of the scaling procedure
timeFrame: Day 1
measure: Patient assessment of the two pharmaceutical formulations
timeFrame: Day 1
measure: 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.
timeFrame: Daiy 1
Other outcomes:
Locations:
city: Copenhagen K
country: Denmark
facility: Tandlægerne Vimmelskaftet
city: Frederiksberg
country: Denmark
facility: Frederiksberg Tandlægerne
city: Hvidovre
country: Denmark
facility: Tandlægepraksis ved Jonna Bork
Study officials:
affiliation: Hvidovre UH
name: Ove Andersen, MD
role: STUDY_DIRECTOR
References: