Status:
COMPLETED
Acceptance and Preference of Lidocaine Gel Compared to Injection Anesthesia After Non Surgical Periodontal Treatment
Lead Sponsor:
Chemische Fabrik Kreussler & CO GmbH
Collaborating Sponsors:
Anfomed GmbH
Conditions:
Periodontitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 injectio...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 5 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 2 2018
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT03354312
Start Date
December 5 2017
End Date
November 2 2018
Last Update
December 20 2018
Active Locations (5)
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1
Praxis Dr. Heckel
Röttenbach, Bavaria, Germany, 91341
2
Praxis Dr. Petersilka
Würzburg, Bavaria, Germany, 97070
3
Universitätsklinikum Giessen und Marburg GmbH, Standort Marburg
Marburg, Hesse, Germany, 35033
4
Universitätsklinikum Schleswig-Holstein, Klinik für Zahnerhaltungskunde und Parodontologie
Kiel, Schleswig-Holstein, Germany, 24105