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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-06-30

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.

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bupivacaine lozenge

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

Group Type EXPERIMENTAL

Bupivacaine lozenge

Intervention Type DRUG

Lidocaine-adrenalin injection

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.

Group Type ACTIVE_COMPARATOR

Lidocaine-adrenalin injection

Intervention Type DRUG

Interventions

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Bupivacaine lozenge

Intervention Type DRUG

Lidocaine-adrenalin injection

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No