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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01878864
• Other study ID #: OC004PDS
• Secondary ID: 2012-003430-16
• Status: Terminated
• Phase: Phase 2
• First received: April 19, 2013
• Last updated: April 1, 2015
• Start date: November 2012
• Est. completion date: June 2013

Study information

• Verified date: April 2015
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain and Discomfort During Scaling and Root Planning of Patients With
• Periodontal Diseases
• Periodontitis

Intervention

Drug:
• Bupivacaine lozenge

• Lidocaine-adrenalin injection

Locations

Country	Name	City	State
Denmark	Tandlægerne Vimmelskaftet	Copenhagen K
Denmark	Frederiksberg Tandlægerne	Frederiksberg
Denmark	Tandlægepraksis ved Jonna Bork	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Ove Andersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Investigator evaluation of the scaling procedure	After the scaling and root planning the investigator evaluates the scaling procedure by a questionnaire	Day 1	No
Secondary	Patient assessment of the two pharmaceutical formulations	After the scaling procedure the patient assesses the two pharmaceutical formulations by a questionnaire	Day 1	No
Secondary	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	No