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

Chemische Fabrik Kreussler & CO GmbH94 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Periodontitis

Interventions

Articaine hydrochloride/epinephrine (adrenaline) hydrochlorideDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (5)

Praxis Dr. Heckel

Röttenbach, Bavaria, Germany

Praxis Dr. Petersilka

Würzburg, Bavaria, Germany

Universitätsklinikum Giessen und Marburg GmbH, Standort Marburg

Marburg, Hesse, Germany

Universitätsklinikum Schleswig-Holstein, Klinik für Zahnerhaltungskunde und Parodontologie

Kiel, Schleswig-Holstein, Germany

Charité - Universitätsmedizin Berlin Charité Centrum Zahn-, Mund- und Kieferheilkunde CC 3

Berlin, Germany

Outcomes

Primary Outcomes

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

Time frame: 1 hour post-dose of second treatment

Secondary Outcomes

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

Time frame: 1 hour post-dose

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)

Time frame: 1, 5, 25 hours post-dose

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.

Time frame: 1 hour post-dose

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.

Time frame: 1 hour post-dose

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.

Time frame: 1 hour post-dose

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.

Time frame: 1 hour post-dose

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

Time frame: 1 hour post-dose of second treatment

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

Time frame: 1 hour post-dose

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.

Time frame: 1 hour post-dose

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 €)

Time frame: 1 hour post-dose of second treatment

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.

Time frame: 25 hours post-dose of second treatment