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

Primary Purpose

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

Status
Terminated
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Bupivacaine lozenge
Lidocaine-adrenalin injection
Sponsored by
Ove Andersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain and Discomfort During Scaling and Root Planning of Patients With focused on measuring Pain, Discomfort, Periodontitis, Scaling and Root Planning, Visual Analogue Scale, McGills Pain Questionnaire

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Tandlægerne Vimmelskaftet
  • Frederiksberg Tandlægerne
  • Tandlægepraksis ved Jonna Bork

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Bupivacaine lozenge

Lidocaine-adrenalin injection

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

Investigator evaluation of the scaling procedure
After the scaling and root planning the investigator evaluates the scaling procedure by a questionnaire
Patient assessment of the two pharmaceutical formulations
After the scaling procedure the patient assesses the two pharmaceutical formulations by a questionnaire
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

Full Information

First Posted
April 19, 2013
Last Updated
April 1, 2015
Sponsor
Ove Andersen
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1. Study Identification

Unique Protocol Identification Number
NCT01878864
Brief Title
Effect of Local Anesthesia in Patients With Marginal Periodontitis Undergoing Scaling and Root Planning
Official Title
Effect of Local Anesthesia in Patients With Marginal Periodontitis Undergoing Scaling and Root Planning
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Why Stopped
Too slow patient inclusion and superior effect of the injection
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ove Andersen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain and Discomfort During Scaling and Root Planning of Patients With, Periodontitis
Keywords
Pain, Discomfort, Periodontitis, Scaling and Root Planning, Visual Analogue Scale, McGills Pain Questionnaire

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine lozenge
Arm Type
Experimental
Arm Description
Single dose administration of a 25 mg bupivacaine lozenge before the scaling and root planning was performed.
Arm Title
Lidocaine-adrenalin injection
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine lozenge
Intervention Type
Drug
Intervention Name(s)
Lidocaine-adrenalin injection
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
Day 1
Title
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.
Description
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
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Investigator evaluation of the scaling procedure
Description
After the scaling and root planning the investigator evaluates the scaling procedure by a questionnaire
Time Frame
Day 1
Title
Patient assessment of the two pharmaceutical formulations
Description
After the scaling procedure the patient assesses the two pharmaceutical formulations by a questionnaire
Time Frame
Day 1
Title
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.
Description
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
Time Frame
Daiy 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ove Andersen, MD
Organizational Affiliation
Hvidovre UH
Official's Role
Study Director
Facility Information:
Facility Name
Tandlægerne Vimmelskaftet
City
Copenhagen K
ZIP/Postal Code
1161
Country
Denmark
Facility Name
Frederiksberg Tandlægerne
City
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
Facility Name
Tandlægepraksis ved Jonna Bork
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark

12. IPD Sharing Statement

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

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