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

Ove Andersen

Status and phase: Terminated; Phase 2

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

Treatments: Drug: Lidocaine-adrenalin injection; Drug: Bupivacaine lozenge

Study type: Interventional

Funder types: Other

Identifiers

NCT01878864

2012-003430-16 (EudraCT Number)

OC004PDS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Bupivacaine lozenge

Experimental group

Description:

Single dose administration of a 25 mg bupivacaine lozenge before the scaling and root planning was performed.

Treatment:

Drug: Bupivacaine lozenge

Lidocaine-adrenalin injection

Active Comparator group

Description:

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.

Treatment:

Drug: Lidocaine-adrenalin injection