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    Summary
    EudraCT Number:2016-005202-19
    Sponsor's Protocol Code Number:DyMZIS-01
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-05-08
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2016-005202-19
    A.3Full title of the trial
    Multicenter, randomized, split-mouth study to evaluate the acceptance and preference of lidocaine gel compared to injection anesthesia after non surgical periodontal treatment
    Multizentrische, randomisierte, split-mouth Studie zur Untersuchung der Akzeptanz und Präferenz von Lidocain-Gel im Vergleich zur Injektionsanästhesie im Rahmen der geschlossenen Parodontalbehandlung



    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical study to investigate the acceptance and preference of an anesthetic gel introduced into the gingival pockets compared to anesthetic injection during the non-surgical treatment in the case of inflammation of the tooth bed and tooth holding apparatus
    Klinische Studie zur Untersuchung der Akzeptanz und Präferenz eines in die Zahnfleischtaschen eingebrachten Betäubungsgels im Vergleich zur Betäubungsspritze im Rahmen der nicht-chirurgischen Behandlung bei einer Entzündung des Zahnbetts und Zahnhalteapparats
    A.3.2Name or abbreviated title of the trial where available
    Dynexan Perio Study
    Dynexan Paro Studie
    A.4.1Sponsor's protocol code numberDyMZIS-01
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorChemische Fabrik Kreussler & Co. GmbH
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportChemische Fabrik Kreussler & Co. GmbH
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationChemische Fabrik Kreussler & Co. GmbH
    B.5.2Functional name of contact pointMed.-Wiss Abteilung
    B.5.3 Address:
    B.5.3.1Street AddressRheingaustrasse 87-93
    B.5.3.2Town/ cityWiesbaden
    B.5.3.3Post code65203
    B.5.3.4CountryGermany
    B.5.4Telephone number+496119271184
    B.5.5Fax number+496119271111
    B.5.6E-mailTobias.Wittig@kreussler.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Dynexan Mundgel (cylinder vials containing 1,7 g gel)
    D.2.1.1.2Name of the Marketing Authorisation holderChemische Fabrik Kreussler & Co. GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOromucosal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLIDOCAINE HYDROCHLORIDE
    D.3.9.1CAS number 73-78-9
    D.3.9.4EV Substance CodeSUB88133
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Ultracain D-S 1 : 200.000 (cylinder vials containing 1,7 ml solution)
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-Aventis Deutschland GmbH
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInfiltration
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNARTICAINE HYDROCHLORIDE
    D.3.9.1CAS number 23964-57-0
    D.3.9.4EV Substance CodeSUB00597MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNEpinephrine hydrochloride
    D.3.9.1CAS number 55-31-2
    D.3.9.3Other descriptive nameEPINEPHRINE HYDROCHLORIDE
    D.3.9.4EV Substance CodeSUB01912MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.012
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate parodontitis
    Moderate Parodontitis
    E.1.1.1Medical 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)
    E.1.1.2Therapeutic area Diseases [C] - Mouth and tooth diseases [C07]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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
    E.2.2Secondary 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
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    E.4Principal 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
    E.5 End points
    E.5.1Primary end point(s)
    Comparison of the proportion of patients who prefer gel anesthesia versus the proportion of patients who prefer injection anesthesia
    E.5.1.1Timepoint(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.
    E.5.2Secondary 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
    E.5.2.1Timepoint(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.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Compare acceptance and preference of topical lidocaine mouth gel anesthesia vs. injection anesthesia
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Split-mouth
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    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.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state90
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2017-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-08-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-02
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