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

Chemische Fabrik Kreussler

Status and phase: Completed; Phase 4

Conditions: Periodontitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03354312

DyMZIS-01

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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94 participants in 2 patient groups

Lidocaine/Articaine

Experimental group

Description:

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

Treatment:

Drug: Lidocaine Hydrochloride 1% Gel

Drug: Articaine hydrochloride/epinephrine (adrenaline) hydrochloride

Articaine/Lidocaine

Experimental group

Description:

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

Treatment:

Drug: Lidocaine Hydrochloride 1% Gel

Drug: Articaine hydrochloride/epinephrine (adrenaline) hydrochloride