Multicenter, Randomized, Split-mouth Study to Evaluate the Acceptance and Preference of Lidocaine Gel Compared to Injection Anesthesia After Non Surgical Periodontal Treatment

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.

Start Date05 Dec 2017

Sponsor / Collaborator

Chemische Fabrik Kreussler & Co. GmbH

[+1]

EUCTR2016-005202-19-DE / Not yet recruitingPhase 4

Multicenter, randomized, split-mouth study to evaluate the acceptance and preference of lidocaine gel compared to injection anesthesia after non surgical periodontal treatment - Dynexan Perio Study

Start Date07 Sep 2017

Sponsor / Collaborator

Chemische Fabrik Kreussler & Co. GmbH

EUCTR2011-005336-25-DE / Unknown statusNot Applicable

A randomiszed, mono-center, placebo-controlled, double-blind, comparative study to evaluate the efficacy and safety of Dynexan® Mundgel in minors with acute painful sites of the mouth. - Dynexan® in children with acute painful sites of the mouth

Start Date23 Mar 2012

Sponsor / Collaborator

Chemische Fabrik Kreussler & Co. GmbH

100 Clinical Results associated with Chemische Fabrik Kreussler & Co. GmbH

0 Patents (Medical) associated with Chemische Fabrik Kreussler & Co. GmbH

Literatures (Medical) associated with Chemische Fabrik Kreussler & Co. GmbH

08 Feb 2019·Clinical Oral InvestigationsQ2 · MEDICINE

Non-interventional study to collect data for the application of lidocaine gel 2% during scaling and root planing and professional mechanical plaque removal

Q2 · MEDICINE

Article

Author: Wittig, Tobias ; Otto, Joachim ; Petersilka, Gregor J ; Arweiler, Nicole B

AbstractObjectivesEvaluation of the safety and efficacy of a topical lidocaine gel 2% (LG) during scaling and root planing (SRP) and professional mechanical plaque removal (PMPR).Materials and methodsThe anesthetic effects as well as unwanted effects of LG prior to or during SRP and PMPR were evaluated in an observational, non-randomized, non-interventional study design. A total of 385 treatments were recorded in 68 study centers all over Germany. Rating of the anesthetic effect of LG by treating personnel and patients using a four-item verbal rating scale (VRS), tolerability, safety (adverse effects), and need for additional local injection anesthesia (ALI).ResultsIn SRP as well as in PMPR, application of LG allowed a sufficiently pain-free therapy in more than 90% of the patients as stated on the VRS (SRP: 97.8%, PMPR: 93.75%). Overall, ALI was needed in only 4.23% of the patients treated (SRP: 5.3%, PMPR: 2.62%). One adverse effect occurred within the observation.ConclusionsApplication of LG may offer a safe and effective way to achieve pain-free therapy in periodontal patients.Clinical relevancePatient compliance is key to the success of periodontal maintenance therapy. Effective and safe pain control during various kinds of periodontal therapy might increase patient compliance and therefore contribute to the long-term treatment success, among other factors. With regard to the patients observed in this study, 47% had previously received periodontal maintenance therapy and were therefore familiar with the treatment and the associated pain.

01 Jan 2015·International Journal of Pediatrics

Efficacy and Safety of a Lidocaine Gel in Patients from 6 Months up to 8 Years with Acute Painful Sites in the Oral Cavity: A Randomized, Placebo-Controlled, Double-Blind, Comparative Study

Article

Author: Wolf, Dörte ; Otto, Joachim

Lidocaine is a well-accepted topical anaesthetic, also used in minors to treat painful conditions on mucosal membranes. This randomized, double-blind, placebo-controlled study (registered prospectively as EudraCT number2011-005336-25) was designed to generate efficacy and safety data for a lidocaine gel (2%) in younger children with painful conditions in the oral cavity. One hundred sixty-one children were included in two subgroups: 4–8 years, average age 6.4 years, treated with verum or placebo and 6 months–<4 years, average age 1.8 years, treated only with verum. Pain reduction was measured from the time prior to administration to 10 or 30 minutes after. In addition, adverse events and local tolerability were evaluated. In group I, pain was reduced significantly after treatment with verum compared to placebo at both time points. In group II, the individual pain rating shift showed statistically significant lower pain after treatment. Only seven out of 161 patients reported an adverse event but none were classified as being related to the study medication. The local tolerability was assessed as very good in over 97% of cases. For painful sites in the oral cavity, a 2% lidocaine gel is a meaningful tool for short-term treatment in the paediatric population.

01 Oct 2013·International Journal of Colorectal DiseaseQ3 · MEDICINE

Efficacy and safety of sclerotherapy with polidocanol foam in comparison with fluid sclerosant in the treatment of first-grade haemorrhoidal disease: a randomised, controlled, single-blind, multicentre trial

Q3 · MEDICINE

Article

Author: Maren Walgenbach ; Andreas K. Joos ; Jan Kirsch ; Petra Gliem ; Christoph Mosch ; Stefan Sauerland ; Dieter G. Bussen ; Karl-Heinz Moser

PURPOSESclerotherapy is the treatment of choice for first-grade haemorrhoidal disease. Numerous studies have shown that sclerotherapy with foamed sclerosants is more efficacious than liquid in the treatment of varicose veins. The aim of this study was to assess the efficacy and safety of polidocanol foam in comparison with liquid for haemorrhoidal disease.METHODSA total of 130 patients were randomised to foam or liquid sclerotherapy (polidocanol 3%). Patients with first-grade haemorrhoidal disease were included and blinded to treatment assignment. The primary endpoint was the stopping of perianal bleeding after one sclerotherapy session. Sclerotherapy was repeated until patients were free of bleeding (2-week intervals). The final follow-up was 12 weeks after the last sclerotherapy session.RESULTSIn the foam group, significantly more patients (88%) were treated successfully after one sclerotherapy session compared to the liquid group (69%; p = 0.01). There was high patient satisfaction in both groups, but significantly more patients were satisfied with their treatment in the foam group than in the liquid group (99 vs. 84%; p = 0.009). Additionally, in the foam group, significantly less treatment sessions were required (p < 0.001), and the total amount of injected polidocanol was reduced (p < 0.001).CONCLUSIONIn the therapy of first-grade haemorrhoidal disease, polidocanol 3 % foam is more effective and equally safe compared to liquid polidocanol. The results of this trial show that foam sclerotherapy is a new, innovative, effective and safe non-surgical treatment option for haemorrhoidal disease.

100 Deals associated with Chemische Fabrik Kreussler & Co. GmbH

100 Translational Medicine associated with Chemische Fabrik Kreussler & Co. GmbH

Corporation Tree

Boost your research with our corporation tree data.

view full example data

Pipeline

Pipeline Snapshot as of 17 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Approved

Current Projects

Drug(Targets)	Indications	Global Highest Phase

Polidocanol ( mAChRs )	Varicose Veins More	Approved

Deal

Boost your decision using our deal data.

view full example data

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Profit

Explore the financial positions of over 360K organizations with Synapse.

view full example data

Grant & Funding(NIH)

Access more than 2 million grant and funding information to elevate your research journey.

view full example data

Investment

Gain insights on the latest company investments from start-ups to established corporations.

view full example data

Financing

Unearth financing trends to validate and advance investment opportunities.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis