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    Summary
    EudraCT Number:2013-005305-31
    Sponsor's Protocol Code Number:2013v01
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-02-12
    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 ConcernedSweden - MPA
    A.2EudraCT number2013-005305-31
    A.3Full title of the trial
    Ice as topical anaesthesia before injection in the oral mucosa
    –a randomized unblinded cross-over study in adolescents. Comparison between ice and lidokain gel 5%.
    Kyla som ytanestesi före injektion inom tandvården
    -en randomiserad oblindad cross-over studie på ungdomar. Jämförelse mellan kyla och lidokainsalva 5 %.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ice to reduce pain before dental injection
    Kyla för att minska smärta av bedövning i tandvården
    A.3.2Name or abbreviated title of the trial where available
    Topical anaesthesia with ice in dentistry
    Ytanestesi med is i tandvården
    A.4.1Sponsor's protocol code number2013v01
    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 SponsorFolktandvården Östergötland
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportFolktandvården Östergötland
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFolktandvården Östergötland
    B.5.2Functional name of contact pointMats Bågesund
    B.5.3 Address:
    B.5.3.1Street AddressCentrum för ortodonti/pedodonti. Folktandvården Druvan
    B.5.3.2Town/ cityNorrköping
    B.5.3.3Post code60182
    B.5.3.4CountrySweden
    B.5.4Telephone number+46761273222
    B.5.6E-mailmats.bagesund@lio.se
    D. IMP Identification
    D.IMP: 1
    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 Lidokainsalva APL 5% munhålepasta
    D.2.1.1.2Name of the Marketing Authorisation holderApotek produktion och laboratorier AB
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 Gingival gel
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPGingival use
    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
    The patients should be < 20 years and reffered by an orthodontist with two contra lateral premolars in the upper jaw that has to be extracted. They should not have any diseases or medications that, according to the investigator, affects the security of the patient or the quality of the study. Furthermore, they should not have dental fear.
    Patienterna ska vara < 20 år och ha två premolarer bilateralt i maxillan som ska extraheras ortodontiskt enligt remiss från en ortodontist. De ska inte ha något sjukdomstillstånd eller medicinering som enligt prövarens bedömning påverkar patientens säkerhet eller studiens kvalité. De ska heller inte vara tandvårdsrädda.
    E.1.1.1Medical condition in easily understood language
    The patients should be < 20 years, healthy and have two contra lateral premolars in the upper jaw that has to be extracted orthodontically.
    Patienterna ska vara < 20 år, friska och ha två premolarer i maxillan som extraheras ortodontiskt.
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
    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 aim of the study is to evaluate if the anesthetic effect and the patients' subjective experience is better when using cold than when using Lidocain gel 5%.
    Målet med studien är att utvärdera om bedövningseffekten och den subjektiva upplevelsen hos patient av kyla är bättre än vid användande av Lidokainsalva 5 %.
    E.2.2Secondary objectives of the trial
    Not applicable
    Inte aktuellt
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • The patients should have two contra lateral premolars in the upper jaw that are going to be extracted orthodontically after a referral from an orthodontist
    • Age < 20år
    • Informed consent from patient and legal guardian when necessary (<18 years)
    • Patienterna ska ha två premolarer bilateralt i maxillan som ska extraheras ortodontiskt enligt remiss från en ortodontist.
    • Ålder < 20år
    • Informerat samtycke från forskningsperson och vårdnadshavare i de fall det är nödvändigt (<18 år)
    E.4Principal exclusion criteria
    • Disease or medication that according to the investigator affects the security of the patient or the quality of the study.
    • Expressed dental fear according to health declaration or according to the investigator.
    • Hypersensitivity to local anesthesia of amide type or to any of the other ingredients.
    • Sjukdomstillstånd eller medicinering som enligt prövarens bedömning påverkar patientens säkerhet eller studiens kvalité.
    • Uttalad tandvårdsrädsla enligt hälsodeklaration eller enligt tandläkarens bedömning
    • Överkänslighet mot lokalanestetika av amidtyp eller för något av de övriga innehållsämnena
    E.5 End points
    E.5.1Primary end point(s)
    According to the vas scale we expect ice to be at least 4mm lower on a 100mm vas scale.
    Utifrån VAS-skalan förväntas is ligga minst 4mm lägre på en 100mm Vas-skala
    E.5.1.1Timepoint(s) of evaluation of this end point
    Baseline, 1min, 2,5min and 5min after application of local anaesthesia and after injection.
    Baseline, 1min, 2,5min och 5min efter applicering av lokalanestesi och efter injektion.
    E.5.2Secondary end point(s)
    70% of the patients will prefer ice over lidocain gel.
    70% av patienterna kommer att föredra is för lidokainsalva.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Questionnaire after the last visit
    Enkätsvar efter sista besöket
    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 Yes
    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 No
    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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Is är vår intervention. Lidokainsalva används som kontrollsubstans.
    Ice is used as test. Lidocaine gel is used as a comparator.
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    Last follow up phone call after LVLS
    Sista uppföljande telefonsamtal efter sista patientens sista besök.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 35
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 1
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 34
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5
    F.1.3Elderly (>=65 years) No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-02-12. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Consent will be taken from legal guardians and the children.
    Samtycke inhämtas av både vårdnadshavare och barn.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state40
    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
    Ingen
    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 Decision2014-03-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-08-23
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