Effect of local anesthesia in patients with chronic gingivitis undergoing dental cleanings

Effect of local anesthesia in patients with marginal periodontitis undergoing subgingival scaling - PSD Lozenge

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-003430-16-DK

Enrollment

Unknown

Registered

2012-11-15

Start date

2012-11-15

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain and discomfort during dental treatment in patients with periodontitis MedDRA version: 15.1 Level: LLT Classification code 10009102 Term: Chronic periodontitis System Organ Class: 100000004862

Interventions

Product Name: Bupizenge Product Code: BUPI25 Pharmaceutical Form: Lozenge CAS Number: 18010-40-7 Other descriptive name: BUPIVACAINE HYDROCHLORIDE Concentration unit: IU/mg international unit(s)/milli

Eligibility

Sex/Gender

All

Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate that the effect of the lozenge is not worse than the effect of the injection during subgingival depuration;Secondary Objective: The patient evaluates - the pharmaceutical form of the two local anesthetic - the taste and texture of the lozenge The dentist evaluates the depuration;Primary end point(s): To demonstrate that the effect of the lozenge is not worse than the effect of the injection during subgingival depuration The patient scores the level of pain by: -Visual Analog Scale (VAS) 0-10 where 0 = no pain, 10 = extreme pain. -McGills Pain Questionnaire (MPQ), which gives a qualitative pain profile. The patient scores the level of discomfort by: -Visual Analog Scale (VAS) 0-10 where 0 = no discomfort, 10 = extreme discomfort.;Timepoint(s) of evaluation of this end point: The patient evaluates pain and discomfort before, during and after the depuration by VAS and MPQ.	—

Measure

Time frame

Main Objective: To demonstrate that the effect of the lozenge is not worse than the effect of the injection during subgingival depuration;Secondary Objective: The patient evaluates - the pharmaceutical form of the two local anesthetic - the taste and texture of the lozenge The dentist evaluates the depuration;Primary end point(s): To demonstrate that the effect of the lozenge is not worse than the effect of the injection during subgingival depuration The patient scores the level of pain by: -Visual Analog Scale (VAS) 0-10 where 0 = no pain, 10 = extreme pain. -McGills Pain Questionnaire (MPQ), which gives a qualitative pain profile. The patient scores the level of discomfort by: -Visual Analog Scale (VAS) 0-10 where 0 = no discomfort, 10 = extreme discomfort.;Timepoint(s) of evaluation of this end point: The patient evaluates pain and discomfort before, during and after the depuration by VAS and MPQ.

—

Secondary

Measure	Time frame
Secondary end point(s): The patient evaluates - the pharmaceutical form of the two local anesthetic using a questionnaire - the taste and texture of the lozenge using a questionnaire The dentist evaluates the depuration using a questionnaire;Timepoint(s) of evaluation of this end point: - The patient evaluates the pharmaceutical forms after the depuration - The patient assesses taste and texture of the lozenge after the depuration - The dentist evaluates the depuration after the procedure	—

Measure

Time frame

Secondary end point(s): The patient evaluates - the pharmaceutical form of the two local anesthetic using a questionnaire - the taste and texture of the lozenge using a questionnaire The dentist evaluates the depuration using a questionnaire;Timepoint(s) of evaluation of this end point: - The patient evaluates the pharmaceutical forms after the depuration - The patient assesses taste and texture of the lozenge after the depuration - The dentist evaluates the depuration after the procedure

—

Countries

Denmark

Contacts

Public ContactStine Mogensen

Clinical Research Centre, Hvidovre University Hospital

sugetablet@gmail.com004538626077

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026