Clinical trial NCT03354312: Acceptance and Preference of Lidocaine Gel Compared to Injection Anesthesia After Non Surgical Periodontal Treatment
Official title: Multicenter, Randomized, Split-mouth Study to Evaluate the Acceptance and Preference of Lidocaine Gel Compared to Injection Anesthesia After Non Surgical Periodontal Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontitis
Keywords: scaling and root planing
topical anesthesia
Lead sponsor: Chemische Fabrik Kreussler & CO GmbH
Sponsor class: INDUSTRY
Collaborators: name: Anfomed GmbH
First posted: 2017-11-27
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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.
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Acceptance and preference of topical lidocaine mouth gel anesthesia
timeFrame: 1 hour post-dose of second treatment
Secondary outcomes:
measure: Assessment of pain
timeFrame: 1 hour post-dose
measure: Side Effects
timeFrame: 1, 5, 25 hours post-dose
measure: Handling/Application
timeFrame: 1 hour post-dose
measure: Onset of anesthetic effect
timeFrame: 1 hour post-dose
measure: Duration of anesthetic effect
timeFrame: 1 hour post-dose
measure: Patient compliance
timeFrame: 1 hour post-dose
measure: Treating physicians preference
timeFrame: 1 hour post-dose of second treatment
measure: Anesthesia re-application/rescue anesthesia
timeFrame: 1 hour post-dose
measure: Overall patient satisfaction with anesthesia
timeFrame: 1 hour post-dose
measure: Willingness to pay
timeFrame: 1 hour post-dose of second treatment
measure: Re-Evaluation of patients preference
timeFrame: 25 hours post-dose of second treatment
Other outcomes:
Locations:
city: Röttenbach
country: Germany
facility: Praxis Dr. Heckel
state: Bavaria
city: Würzburg
country: Germany
facility: Praxis Dr. Petersilka
state: Bayern
city: Marburg
country: Germany
facility: Universitätsklinikum Giessen und Marburg GmbH, Standort Marburg
state: Hessen
city: Kiel
country: Germany
facility: Universitätsklinikum Schleswig-Holstein, Klinik für Zahnerhaltungskunde und Parodontologie
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin Charité Centrum Zahn-, Mund- und Kieferheilkunde CC 3
Study officials:
References: