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

Phase 2

Terminated

• Conditions: Pain and Discomfort During Scaling and Root Planning of Patients With; Periodontitis
• Interventions: Drug: Bupivacaine lozenge; Drug: Lidocaine-adrenalin injection

• Registration Number: NCT01878864
• Lead Sponsor: Ove Andersen

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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-04-19
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted QC: 2013-06-13
• Study First Posted: 2013-06-17
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-01
• Last Update Posted: 2015-04-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Bupivacaine lozenge	Bupivacaine lozenge	Single dose administration of a 25 mg bupivacaine lozenge before the scaling and root planning was performed.
Lidocaine-adrenalin injection	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.

Primary Outcome Measures

Name	Time	Method
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 discomfort: -Visual Analog Scale (VAS) 0-10 where 0 = no discomfort, 10 = extreme discomfort

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (3)

Frederiksberg Tandlægerne; 🇩🇰 Frederiksberg, Denmark

Tandlægepraksis ved Jonna Bork; 🇩🇰 Hvidovre, Denmark

Tandlægerne Vimmelskaftet; 🇩🇰 Copenhagen K, Denmark