NCT01878864

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 17, 2013

Completed
Last Updated

April 3, 2015

Status Verified

April 1, 2015

Enrollment Period

7 months

First QC Date

April 19, 2013

Last Update Submit

April 1, 2015

Conditions

Pain and Discomfort During Scaling and Root Planning of Patients WithPeriodontitis

Keywords

Pain, Discomfort, Periodontitis, Scaling and Root Planning, Visual Analogue Scale, McGills Pain Questionnaire

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Investigator evaluation of the scaling procedure

    Day 1

  • Patient assessment of the two pharmaceutical formulations

    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.

    Daiy 1

Study Arms (2)

Bupivacaine lozenge

EXPERIMENTAL

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

Drug: Bupivacaine lozenge

Lidocaine-adrenalin injection

ACTIVE COMPARATOR

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

Interventions

Bupivacaine lozengeDRUG
Bupivacaine lozenge
Lidocaine-adrenalin injectionDRUG
Lidocaine-adrenalin injection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Tandlægerne Vimmelskaftet

Copenhagen K, 1161, Denmark

Location

Frederiksberg Tandlægerne

Frederiksberg, 2000, Denmark

Location

Tandlægepraksis ved Jonna Bork

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

PainPeriodontitis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Ove Andersen, MD

    Hvidovre UH

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 19, 2013

First Posted

June 17, 2013

Study Start

November 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

April 3, 2015

Record last verified: 2015-04

Locations

DK(3)