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Acceptance and Preference of Lidocaine Gel Compared to Injection Anesthesia After Non Surgical Periodontal Treatment

Primary Purpose

Periodontitis

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Lidocaine Hydrochloride 1% Gel
Articaine hydrochloride/epinephrine (adrenaline) hydrochloride
Sponsored by
Chemische Fabrik Kreussler & CO GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Periodontitis focused on measuring scaling and root planing, topical anesthesia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Signed informed consent must be available
  • Willingness and ability to comply with scheduled visits, treatment plan, and other study procedures
  • Patient systemically healthy except for controlled diabetes and hypertension
  • Patients with comparable periodontal status of the right and left jaw, with ≥ 3 teeth with pockets ≥ 4 mm and ≤ 7 mm per quadrant
  • Female patients of childbearing potential must practice highly effective contraception methods

Exclusion Criteria:

  • Generalized severe periodontitis with pockets > 8 mm
  • More than 2 pockets > 7 mm and ≤ 8 mm per quadrant

  • Contraindicated for treatment with the investigational product, the comparator drug, or meet warnings and precautions for use specifications in accordance with the approved SmPCs as follows:

    • Hypersensitivity to the investigational product, the comparator drug or to any of their respective excipients
    • Hypersensitivity to other local anesthetics of the amide type
    • Severe uncontrolled and untreated excitation and conduction disorder of the heart
    • Acute decompensated heart failure
    • Severe renal or hepatic disease/dysfunction
    • Untreated or uncontrolled diabetes type 2
    • Severe hypertension and severe hypotension
    • Narrow-angle glaucoma
    • Hyperthyroidism
    • Paroxysmal tachycardia or high-frequency absolute arrhythmia
    • Myocardial infarction within the last 6 months
    • Coronary artery bypass within the last 3 months
    • Concurrent use of non-cardio selective beta blockers (e.g. propranolol)
    • Pheochromocytoma
    • Concurrent treatment with tri-cyclic antidepressants or monoamine oxidase (MAO) inhibitors
  • Use of painkillers or anti-inflammatory drugs 24 hours before the first treatment
  • Antibiotic prophylaxis or treatment with antibiotics
  • Use of any anxiolytic medication
  • Periodontal treatment within the last 3 months
  • Continuing orthodontic treatment
  • Concurrent use of another investigational medication
  • Participation in another clinical trial within the last 3 months
  • Women who are pregnant or breastfeeding, or planning pregnancy while enrolled in the study
  • Persons who are in a dependency or working relationship with the sponsor or investigator
  • A subject who, in the opinion of the investigator will be uncooperative or unable to comply with study procedures

Sites / Locations

  • Praxis Dr. Heckel
  • Praxis Dr. Petersilka
  • Universitätsklinikum Giessen und Marburg GmbH, Standort Marburg
  • Universitätsklinikum Schleswig-Holstein, Klinik für Zahnerhaltungskunde und Parodontologie
  • Charité - Universitätsmedizin Berlin Charité Centrum Zahn-, Mund- und Kieferheilkunde CC 3

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lidocaine/Articaine

Articaine/Lidocaine

Arm Description

Lidocaine Hydrochloride 1% Gel anesthesia / Articaine hydrochloride/epinephrine (adrenaline) hydrochloride anesthesia

Articaine hydrochloride/epinephrine (adrenaline) hydrochloride anesthesia / Lidocaine Hydrochloride 1% Gel anesthesia

Outcomes

Primary Outcome Measures

Acceptance and preference of topical lidocaine mouth gel anesthesia
To compare acceptance and preference of topical lidocaine mouth gel anesthesia vs. injection anesthesia with articaine in patients undergoing subgingival debridement by comparing the proportion of patients after the second periodontal treatment who prefer topical anesthesia with lidocaine gel against the injection anesthesia with articaine to a proportion of 0.5; the patient rates the preferred anesthesia method on a questionnaire by stating if the patient's preference is treatment with anesthetic gel, treatment with anesthetic injection, or no preference

Secondary Outcome Measures

Assessment of pain
Comparative assessment of pain the patients experienced during treatment; a visual analogue scale (100mm, 0 = no pain, 100 = maximum pain) will be used for maximum pain and average pain Rating after each treatment visit
Side Effects
Evaluate type and number of side effects (incl. after-effects due to study Treatment up to 24h after each treatment visit by use of a patient diary)
Handling/Application
Compare the handling/application of both methods; the treating physician rates the handling/application on a questionnaire by using German school grades (1 = very good, 2 = good, 3 = satisfactory, 4 = adequate, 5 = inadequate, 6 = insufficient) after each treatment visit.
Onset of anesthetic effect
Compare the onset of anesthetic effect in both treatment groups; the treating physician rates the onset of the anesthetic effect on a questionnaire by using German school grades (1 = very good, 2 = good, 3 = satisfactory, 4 = adequate, 5 = inadequate, 6 = insufficient) after each treatment visit.
Duration of anesthetic effect
Compare the duration of anesthetic effect in both treatment groups; the treating physician rates the duration of the anesthetic effect on a questionnaire by using German school grades (1 = very good, 2 = good, 3 = satisfactory, 4 = adequate, 5 = inadequate, 6 = insufficient) after each treatment visit.
Patient compliance
Compare the patient compliance in both treatment groups; the treating physician rates the patient compliance on a questionnaire by using German school grades (1 = very good, 2 = good, 3 = satisfactory, 4 = adequate, 5 = inadequate, 6 = insufficient) after each treatment visit.
Treating physicians preference
Evaluation which of the anesthetic methods the treating physician prefers. The treating physician rates the preferred anesthesia method on a questionnaire by stating if the treating physician's preference is treatment with anesthetic gel, treatment with anesthetic injection, or no preference
Anesthesia re-application/rescue anesthesia
Assess the number of re-application of the anesthetic gel or the rescue anesthesia injections that are required in every treatment group
Overall patient satisfaction with anesthesia
Evaluation of the overall patient satisfaction with anesthesia. The patient rates the overall satisfaction on a questionnaire by using German school grades (1 = very good, 2 = good, 3 = satisfactory, 4 = adequate, 5 = inadequate, 6 = insufficient) after each treatment visit.
Willingness to pay
Evaluation of the willingness to pay for lidocaine gel by using a questionnaire (willingness to pay 0, 1-5, 5-10, 10-15, 15-20 or >20 €)
Re-Evaluation of patients preference
Re-evaluation of preference of topical lidocaine mouth gel anesthesia vs. injection anesthesia with articaine 24 h after end of last treatment. The patient again rates the preferred anesthesia method by stating if his/her preference is treatment with anesthetic gel, treatment with anesthetic injection, or no preference. The preference 24 h after end of last treatment is collected by using the patient diary.

Full Information

First Posted
November 14, 2017
Last Updated
December 19, 2018
Sponsor
Chemische Fabrik Kreussler & CO GmbH
Collaborators
Anfomed GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT03354312
Brief Title
Acceptance and Preference of Lidocaine Gel Compared to Injection Anesthesia After Non Surgical Periodontal Treatment
Official Title
Multicenter, Randomized, Split-mouth Study to Evaluate the Acceptance and Preference of Lidocaine Gel Compared to Injection Anesthesia After Non Surgical Periodontal Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
December 5, 2017 (Actual)
Primary Completion Date
November 2, 2018 (Actual)
Study Completion Date
November 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chemische Fabrik Kreussler & CO GmbH
Collaborators
Anfomed GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This project is a national, open label, multicenter, randomized split-mouth study in patients from 18 to 70 years of age to compare the efficacy and acceptability of lidocaine gel compared to injection anesthesia with articaine (infiltration anesthesia for the upper jaw and infiltration or nerve block anesthesia for the lower jaw). It is planned that about 90 patients with a proven moderate periodontitis will be enrolled in 5 German study centers. Dynexan Mundgel® (lidocaine hydrochloride) is a topical anesthetic gel containing lidocaine that is commercially available as an anesthetic for temporary, symptomatic treatment of pain at the oral mucosa, gingiva and lips. The gold standard for scaling and root planing (SRP) is still the use of injection anesthesia. This raises the question what kind of anesthesia patients would prefer if they had a free choice. For this study Ultracaine® D-S 1:200,000 (articaine hydrochloride/epinephrine hydrochloride) was selected as the injectable comparator drug because it is the most frequently used anesthetic drug for infiltration and nerve-block anesthesia in Germany at present.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
scaling and root planing, topical anesthesia

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Model Description
The randomization determines if a subject will be assigned to receive either lidocaine gel or articaine injection anesthesia as the first anesthesia during SRP Treatment of the right upper and lower jaw. The second anesthesia during SRP at visit 2 will be carried out with the remaining anesthetic on the left side of the upper and lower jaw.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lidocaine/Articaine
Arm Type
Experimental
Arm Description
Lidocaine Hydrochloride 1% Gel anesthesia / Articaine hydrochloride/epinephrine (adrenaline) hydrochloride anesthesia
Arm Title
Articaine/Lidocaine
Arm Type
Experimental
Arm Description
Articaine hydrochloride/epinephrine (adrenaline) hydrochloride anesthesia / Lidocaine Hydrochloride 1% Gel anesthesia
Intervention Type
Drug
Intervention Name(s)
Lidocaine Hydrochloride 1% Gel
Other Intervention Name(s)
Dynexan Mundgel®
Intervention Description
Cylinder vials with 1.7 g gel containing 34 mg lidocaine (1 g gel contains 20 mg lidocaine) will be used. Application of the gel into the periodontal pockets or the sulcus according to summary of product characteristics (SmPC). A total dose of 40 mg lidocaine should not be exceeded.
Intervention Type
Drug
Intervention Name(s)
Articaine hydrochloride/epinephrine (adrenaline) hydrochloride
Other Intervention Name(s)
Ultracain® D-S 1:200,000
Intervention Description
Cylinder vials with 1.7 ml solution for injection containing 68 mg articaine and 0.0102 mg epinephrine (1 ml contains 40 mg articaine and 0.006 mg epinephrine) will be used. Infiltration anesthesia for the upper jaw and infiltration or nerve block anesthesia for the lower jaw with articaine solution for injection according to SmPC. Adults can be treated with up to 7 mg articaine per kg of body weight per treatment session.
Primary Outcome Measure Information:
Title
Acceptance and preference of topical lidocaine mouth gel anesthesia
Description
To compare acceptance and preference of topical lidocaine mouth gel anesthesia vs. injection anesthesia with articaine in patients undergoing subgingival debridement by comparing the proportion of patients after the second periodontal treatment who prefer topical anesthesia with lidocaine gel against the injection anesthesia with articaine to a proportion of 0.5; the patient rates the preferred anesthesia method on a questionnaire by stating if the patient's preference is treatment with anesthetic gel, treatment with anesthetic injection, or no preference
Time Frame
1 hour post-dose of second treatment
Secondary Outcome Measure Information:
Title
Assessment of pain
Description
Comparative assessment of pain the patients experienced during treatment; a visual analogue scale (100mm, 0 = no pain, 100 = maximum pain) will be used for maximum pain and average pain Rating after each treatment visit
Time Frame
1 hour post-dose
Title
Side Effects
Description
Evaluate type and number of side effects (incl. after-effects due to study Treatment up to 24h after each treatment visit by use of a patient diary)
Time Frame
1, 5, 25 hours post-dose
Title
Handling/Application
Description
Compare the handling/application of both methods; the treating physician rates the handling/application on a questionnaire by using German school grades (1 = very good, 2 = good, 3 = satisfactory, 4 = adequate, 5 = inadequate, 6 = insufficient) after each treatment visit.
Time Frame
1 hour post-dose
Title
Onset of anesthetic effect
Description
Compare the onset of anesthetic effect in both treatment groups; the treating physician rates the onset of the anesthetic effect on a questionnaire by using German school grades (1 = very good, 2 = good, 3 = satisfactory, 4 = adequate, 5 = inadequate, 6 = insufficient) after each treatment visit.
Time Frame
1 hour post-dose
Title
Duration of anesthetic effect
Description
Compare the duration of anesthetic effect in both treatment groups; the treating physician rates the duration of the anesthetic effect on a questionnaire by using German school grades (1 = very good, 2 = good, 3 = satisfactory, 4 = adequate, 5 = inadequate, 6 = insufficient) after each treatment visit.
Time Frame
1 hour post-dose
Title
Patient compliance
Description
Compare the patient compliance in both treatment groups; the treating physician rates the patient compliance on a questionnaire by using German school grades (1 = very good, 2 = good, 3 = satisfactory, 4 = adequate, 5 = inadequate, 6 = insufficient) after each treatment visit.
Time Frame
1 hour post-dose
Title
Treating physicians preference
Description
Evaluation which of the anesthetic methods the treating physician prefers. The treating physician rates the preferred anesthesia method on a questionnaire by stating if the treating physician's preference is treatment with anesthetic gel, treatment with anesthetic injection, or no preference
Time Frame
1 hour post-dose of second treatment
Title
Anesthesia re-application/rescue anesthesia
Description
Assess the number of re-application of the anesthetic gel or the rescue anesthesia injections that are required in every treatment group
Time Frame
1 hour post-dose
Title
Overall patient satisfaction with anesthesia
Description
Evaluation of the overall patient satisfaction with anesthesia. The patient rates the overall satisfaction on a questionnaire by using German school grades (1 = very good, 2 = good, 3 = satisfactory, 4 = adequate, 5 = inadequate, 6 = insufficient) after each treatment visit.
Time Frame
1 hour post-dose
Title
Willingness to pay
Description
Evaluation of the willingness to pay for lidocaine gel by using a questionnaire (willingness to pay 0, 1-5, 5-10, 10-15, 15-20 or >20 €)
Time Frame
1 hour post-dose of second treatment
Title
Re-Evaluation of patients preference
Description
Re-evaluation of preference of topical lidocaine mouth gel anesthesia vs. injection anesthesia with articaine 24 h after end of last treatment. The patient again rates the preferred anesthesia method by stating if his/her preference is treatment with anesthetic gel, treatment with anesthetic injection, or no preference. The preference 24 h after end of last treatment is collected by using the patient diary.
Time Frame
25 hours post-dose of second treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent must be available Willingness and ability to comply with scheduled visits, treatment plan, and other study procedures Patient systemically healthy except for controlled diabetes and hypertension Patients with comparable periodontal status of the right and left jaw, with ≥ 3 teeth with pockets ≥ 4 mm and ≤ 7 mm per quadrant Female patients of childbearing potential must practice highly effective contraception methods Exclusion Criteria: Generalized severe periodontitis with pockets > 8 mm More than 2 pockets > 7 mm and ≤ 8 mm per quadrant Contraindicated for treatment with the investigational product, the comparator drug, or meet warnings and precautions for use specifications in accordance with the approved SmPCs as follows: Hypersensitivity to the investigational product, the comparator drug or to any of their respective excipients Hypersensitivity to other local anesthetics of the amide type Severe uncontrolled and untreated excitation and conduction disorder of the heart Acute decompensated heart failure Severe renal or hepatic disease/dysfunction Untreated or uncontrolled diabetes type 2 Severe hypertension and severe hypotension Narrow-angle glaucoma Hyperthyroidism Paroxysmal tachycardia or high-frequency absolute arrhythmia Myocardial infarction within the last 6 months Coronary artery bypass within the last 3 months Concurrent use of non-cardio selective beta blockers (e.g. propranolol) Pheochromocytoma Concurrent treatment with tri-cyclic antidepressants or monoamine oxidase (MAO) inhibitors Use of painkillers or anti-inflammatory drugs 24 hours before the first treatment Antibiotic prophylaxis or treatment with antibiotics Use of any anxiolytic medication Periodontal treatment within the last 3 months Continuing orthodontic treatment Concurrent use of another investigational medication Participation in another clinical trial within the last 3 months Women who are pregnant or breastfeeding, or planning pregnancy while enrolled in the study Persons who are in a dependency or working relationship with the sponsor or investigator A subject who, in the opinion of the investigator will be uncooperative or unable to comply with study procedures
Facility Information:
Facility Name
Praxis Dr. Heckel
City
Röttenbach
State/Province
Bavaria
ZIP/Postal Code
91341
Country
Germany
Facility Name
Praxis Dr. Petersilka
City
Würzburg
State/Province
Bayern
ZIP/Postal Code
97070
Country
Germany
Facility Name
Universitätsklinikum Giessen und Marburg GmbH, Standort Marburg
City
Marburg
State/Province
Hessen
ZIP/Postal Code
35033
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein, Klinik für Zahnerhaltungskunde und Parodontologie
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin Charité Centrum Zahn-, Mund- und Kieferheilkunde CC 3
City
Berlin
ZIP/Postal Code
14197
Country
Germany

12. IPD Sharing Statement

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Acceptance and Preference of Lidocaine Gel Compared to Injection Anesthesia After Non Surgical Periodontal Treatment

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