Acceptance and Preference of Lidocaine Gel Compared to Injection Anesthesia After Non Surgical Periodontal Treatment
Status:
Completed
Trial end date:
2018-11-02
Target enrollment:
Participant gender:
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.