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

NCT03354312 | Completed Phase 4

• 1 other identifier: DyMZIS-01
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• 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

  1 hour post-dose of second treatment

Secondary Outcomes (11)

• Assessment of pain

  1 hour post-dose

• Side Effects

  1, 5, 25 hours post-dose

• Handling/Application

  1 hour post-dose

• Onset of anesthetic effect

  1 hour post-dose

• Duration of anesthetic effect

  1 hour post-dose

Study Arms (2)

Lidocaine/Articaine

EXPERIMENTAL

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

Drug: Lidocaine Hydrochloride 1% Gel; Drug: Articaine hydrochloride/epinephrine (adrenaline) hydrochloride

Articaine/Lidocaine

EXPERIMENTAL

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

Drug: Lidocaine Hydrochloride 1% Gel; Drug: Articaine hydrochloride/epinephrine (adrenaline) hydrochloride

Interventions

Lidocaine Hydrochloride 1% Gel 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.

Also known as: Dynexan Mundgel®

Articaine/Lidocaine; Lidocaine/Articaine

Articaine hydrochloride/epinephrine (adrenaline) hydrochloride 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.

Also known as: Ultracain® D-S 1:200,000

Articaine/Lidocaine; Lidocaine/Articaine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chemische Fabrik Kreussler & CO GmbH: lead
• Anfomed GmbH: collaborator

Study Sites (5)

Praxis Dr. Heckel

Röttenbach, Bavaria, 91341, Germany

Location

Praxis Dr. Petersilka

Würzburg, Bavaria, 97070, Germany

Location

Universitätsklinikum Giessen und Marburg GmbH, Standort Marburg

Marburg, Hesse, 35033, Germany

Location

Universitätsklinikum Schleswig-Holstein, Klinik für Zahnerhaltungskunde und Parodontologie

Kiel, Schleswig-Holstein, 24105, Germany

Location

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

Berlin, 14197, Germany

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Lidocaine; Gels; Carticaine; Epinephrine

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: November 27, 2017
• Study Start: December 5, 2017
• Primary Completion: November 2, 2018
• Study Completion: November 2, 2018
• Last Updated: December 20, 2018

Record last verified: 2018-12

Locations

DE (5)