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

Phase 1

Conditions: Pain and discomfort during dental treatment in patients with periodontitis
MedDRA version: 15.1Level: LLTClassification code 10009102Term: Chronic periodontitisSystem Organ Class: 100000004862
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2012-003430-16-DK

Lead Sponsor: Clinical Reasearch Centre, Hvidovre University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

-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

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br> - the pharmaceutical form of the two local anesthetic<br> - the taste and texture of the lozenge<br>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<br>The patient scores the level of pain by:<br>-Visual Analog Scale (VAS) 0-10 where 0 = no pain, 10 = extreme pain.<br>-McGills Pain Questionnaire (MPQ), which gives a qualitative pain profile.<br>The patient scores the level of discomfort by:<br>-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.<br>

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The patient evaluates <br> - the pharmaceutical form of the two local anesthetic using a questionnaire<br> - the taste and texture of the lozenge using a questionnaire <br>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<br>- The patient assesses taste and texture of the lozenge after the depuration<br>- The dentist evaluates the depuration after the procedure