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

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.

Study Overview

• Status: Terminated
• Conditions: Periodontitis; Pain and Discomfort During Scaling and Root Planning of Patients With
• Intervention / Treatment: Drug: Bupivacaine lozenge; Drug: Lidocaine-adrenalin injection

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen K, Denmark, 1161
    • Tandlægerne Vimmelskaftet
  • Frederiksberg, Denmark, 2000
    • Frederiksberg Tandlægerne
  • Hvidovre, Denmark, 2650
    • Tandlægepraksis ved Jonna Bork

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bupivacaine lozenge; Single dose administration of a 25 mg bupivacaine lozenge before the scaling and root planning was performed.	Drug: Bupivacaine lozenge
ACTIVE_COMPARATOR: 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.	Drug: Lidocaine-adrenalin injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	Day 1
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.	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	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator evaluation of the scaling procedure	After the scaling and root planning the investigator evaluates the scaling procedure by a questionnaire	Day 1
Patient assessment of the two pharmaceutical formulations	After the scaling procedure the patient assesses the two pharmaceutical formulations by a questionnaire	Day 1
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.	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	Daiy 1

Collaborators and Investigators

• Sponsor: Ove Andersen
• Investigators: Study Director: Ove Andersen, MD, Hvidovre UH

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ACTUAL): June 1, 2013
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: April 19, 2013
• First Submitted That Met QC Criteria: June 13, 2013
• First Posted (ESTIMATE): June 17, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): April 3, 2015
• Last Update Submitted That Met QC Criteria: April 1, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Pain, Discomfort, Periodontitis, Scaling and Root Planning, Visual Analogue Scale, McGills Pain Questionnaire
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Bupivacaine
• Other Study ID Numbers: OC004PDS; 2012-003430-16 (EUDRACT_NUMBER)