E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Moderate parodontitis |
Moderate Parodontitis |
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E.1.1.1 | Medical condition in easily understood language |
Gum disease (inflammation of the tooth bed and and tooth retaining apparatus) |
Parodontitis, veraltet: Parodontose (Entzündung des Zahnbetts und Zahnhalteapparats) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Mouth and tooth diseases [C07] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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
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E.5 End points |
E.5.1 | Primary end point(s) |
Comparison of the proportion of patients who prefer gel anesthesia versus the proportion of patients who prefer injection anesthesia |
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E.5.1.1 | 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. |
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E.5.2 | 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 |
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E.5.2.1 | 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 back to the study site. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Compare acceptance and preference of topical lidocaine mouth gel anesthesia vs. injection anesthesia |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |