NCT03354312

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

Completed Phase 4 Last updated 20 December 2018

What this trial tests

Phase 4 trial testing Lidocaine Hydrochloride 1% Gel in Periodontitis in 94 participants. Completed in 2 November 2018.

Timeline

5 December 2017

Primary endpoint
2 November 2018

2 November 2018

Quick facts

Lead sponsor	Chemische Fabrik Kreussler & CO GmbH
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	other
Enrollment	94
Start date	5 December 2017
Primary completion	2 November 2018
Estimated completion	2 November 2018
Sites	5 locations across Germany

Drugs / interventions tested

• Lidocaine Hydrochloride 1% Gel
• Articaine hydrochloride/epinephrine (adrenaline) hydrochloride — full drug profile →

Conditions studied

• Periodontitis — all drugs for Periodontitis →

Sponsor

Chemische Fabrik Kreussler & CO GmbH — full company profile →

Who can join

Adults 18 to 70, any sex, with Periodontitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Reporting characteristics of nonsurgical periodontal therapy trials registered in ClinicalTrials.gov: an observational study.
   Stazić P, Jurić D, Turić A, Šošić A, et al · · 2023 · cited 3× · PMID 37418255 · DOI 10.57264/cer-2023-0058