Moderate parodontitis
Conditions
Interventions
Trade Name: Dynexan Mundgel (cylinder vials containing 1,7 g gel)
Pharmaceutical Form: Gel
INN or Proposed INN: LIDOCAINE HYDROCHLORIDE
CAS Number: 73-78-9
Concentration unit: mg/g milligram(s)/gram
Sponsors
Chemische Fabrik Kreussler & Co. GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients 18-70 years of age 2) Signed informed consent must be available 3) Willingness and ability to comply with scheduled visits, treatment plan, and other study procedures 4) Patient systemically healthy except for controlled diabetes or hypertension 5) Patients with comparable periodontal status of the right and left jaw, with = 3 teeth with pockets = 4 mm and = 7 mm per quadrant 6) Female patients of childbearing potential must practice highly effective contraception methods Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1) Generalized severe periodontitis with pockets > 8 mm 2) More than 2 pockets > 7 mm and = 8 mm per quadrant 3) Contraindicated for treatment with the investigational product, the comparator drug, or meet special 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 MAO inhibitors 4) Use of painkillers or anti-inflammatory drugs 24 hours before the first treatment 5) Antibiotic prophylaxis or treatment with antibiotics 6) Use of any anxiolytic medication 7) Periodontal treatment within the last 3 months 8) Continuing orthodontic treatment 9) Concurrent use of another investigational medication 10) Participation in another clinical trial within the last 3 months 11) Women who are pregnant or breastfeeding, or planning pregnancy while enrolled in the study 12) Persons who are in a dependency or working relationship with the sponsor or investigator 13) A subject who, in the opinion of the investigator will be uncooperative or unable to comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare acceptance and preference of topical lidocaine mouth gel anesthesia vs. injection anesthesia with articaine in patients undergoing subgingival debridement by comparing the proportion of patients after the second periodontal treatment who prefer topical anesthesia with lidocaine gel against the injection anesthesia with articaine to a proportion of 0.5; the patient rates the preferred anesthesia method on a questionnaire by stating if the patient’s preference is treatment with anesthetic gel, treatment with anesthetic injection, or no preference;Secondary Objective: Comparative assessment of maximum and average pain the patients experienced during treatment Evaluate type and number of side effects (incl. after-effects due to study treatment) Compare the handling/application of both methods Compare the onset of anesthetic effect in both treatment groups Compare the duration of anesthetic effect in both treatment groups Compare the patient compliance in both treatment groups Evaluate which of the anesthetic methods the treating physician prefers Assess the number of re-application of the anesthetic gel or the rescue anesthesia injections that are required in every treatment group Evaluation of the overall patient satisfaction with anesthesia Evaluation of the willingness to pay for lidocaine gel Re-evaluation of preference of topical lidocaine mouth gel anesthesia vs. injection anesthesia with articaine 24 h after end of last treatment;Primary end point(s): Comparison of the proportion of patients who prefer gel anesthesia versus the proportion of patients who prefer injection anesthesia;Timepoint(s) of evaluation of this end point: Evaluation of the end point can be performed after the second treatment session (visit 2) has been completed and the patient has filled out the questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Comparison of the patients maximum and average pain ratings in mm on a VAS (0-100 mm) in the gel anesthesia group versus the patients maximum and average pain ratings in mm on a VAS (0-100 mm) in the injection anesthesia group Comparison of type and number of side and after effects in the gel anesthesia group versus type and number of side and after effects in the injection anesthesia group Comparison of the treating physicians ratings (German school grades 1-6) concerning the handling/application of both anesthesia methods Comparison of the treating physicians ratings (German school grades 1-6) concerning the onset of the anesthetic effect in both treatment groups Comparison of the treating physicians ratings (German school grades 1-6) concerning the duration of the anesthetic effect in both treatment groups Comparison of the treating physicians ratings (German school grades 1-6) concerning the patient compliance during treatment in both treatment groups Comparison of the number of treating physicians who prefer gel anesthesia versus the number of treating physicians who prefer injection anesthesia Comparison of the number of re-applications of the anesthetic gel or the rescue anesthesia injections required in every treatment group Comparison of the patients ratings (German school grades 1-6) concerning the overall satisfaction in both treatment groups Number of patients who are willing to pay extra for the gel anesthesia. If a patient is willing to pay for the gel anesthesia what amount of money would he/she pay extra? Comparison of the proportion of patients who prefer gel anesthesia versus the proportion of patients who prefer injection anesthesia 24 h after end of last treatment;Timepoint(s) of evaluation of this end point: Evaluation of the secondary end points can be performed after the second treatment session (visit 2) has been completed and the patient has filled out the questionnaire and also has sent the patient diary b | — |
Countries
Germany
Contacts
Public ContactMed.-Wiss Abteilung
Chemische Fabrik Kreussler & Co. GmbH
Outcome results
None listed