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

NCT ID: NCT03354312

Last Updated: 2018-12-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-05
• Study Completion Date: 2018-11-02

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.

Conditions

Periodontitis

Keywords

scaling and root planing; topical anesthesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Lidocaine/Articaine

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

Group Type: EXPERIMENTAL

Lidocaine Hydrochloride 1% Gel

Intervention Type: DRUG

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.

Articaine hydrochloride/epinephrine (adrenaline) hydrochloride

Intervention Type: DRUG

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.

Articaine/Lidocaine

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

Group Type: EXPERIMENTAL

Lidocaine Hydrochloride 1% Gel

Intervention Type: DRUG

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.

Articaine hydrochloride/epinephrine (adrenaline) hydrochloride

Intervention Type: DRUG

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.

Interventions

Lidocaine Hydrochloride 1% Gel

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

Articaine hydrochloride/epinephrine (adrenaline) hydrochloride

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.

Intervention Type: DRUG

Other Intervention Names

Dynexan Mundgel®; Ultracain® D-S 1:200,000

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anfomed GmbH

INDUSTRY

Sponsor Role: collaborator

Chemische Fabrik Kreussler & CO GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

Germany

Other Identifiers

DyMZIS-01

Identifier Type: -

Identifier Source: org_study_id