Trial | NCT03354312  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    94
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.
Study Started
Dec 05
2017
Primary Completion
Nov 02
2018
Study Completion
Nov 02
2018
Last Update
Dec 20
2018

Drug Lidocaine Hydrochloride 1% Gel

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.

  • Other names: Dynexan Mundgel®

Drug Articaine hydrochloride/epinephrine (adrenaline) hydrochloride [articaine (Septocaine), epinephrine (levophed)]

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.

  • Other names: Ultracain® D-S 1:200,000

Lidocaine/Articaine Experimental

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

Articaine/Lidocaine Experimental

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

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
No Results Posted