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    Summary
    EudraCT Number:2013-000383-28
    Sponsor's Protocol Code Number:CLI/016P
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2014-06-20
    Trial results View 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 ConcernedUK - MHRA
    A.2EudraCT number2013-000383-28
    A.3Full title of the trial
    The Efficacy and Safety of Chlorhexidine Gluconate Chip (PerioChip®) in Therapy of Peri-implantitis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The Efficacy and Safety of Chlorhexidine Gluconate Chip (PerioChip®) in Therapy of Peri-implantitis
    A.4.1Sponsor's protocol code numberCLI/016P
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02080403
    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 SponsorDexcel Pharma Technologies Ltd.
    B.1.3.4CountryIsrael
    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 supportDexcel Pharma Technologies Ltd.
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDexcel Pharma (UK) Ltd.
    B.5.2Functional name of contact pointDexcel Clinical Trial Information
    B.5.3 Address:
    B.5.3.1Street Address7 Sopwith Way, Drayton Fields
    B.5.3.2Town/ cityDaventry, Northamptonshire
    B.5.3.3Post code NN11 8PB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441327316859
    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 Periochip 2.5 mg Dental Insert
    D.2.1.1.2Name of the Marketing Authorisation holderDexcel Pharma (UK) Ltd.
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 Periodontal insert
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPPeriodontal 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
    Peri-implantitis
    E.1.1.1Medical condition in easily understood language
    Peri-implantitis is characterized by an inflammatory process injuring the soft and hard tissues around the dental implant and resorption of the bone supporting it.
    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
    To assess the efficacy of Chlorhexidine gluconate chip (PerioChip®) versus Subgingival debridement in Peri-implantitis patients.
    E.2.2Secondary objectives of the trial
    Not applicable
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Signed and dated Informed Consent Form. The patient is of age and is
    capable of understanding the nature, significance and implications of the
    clinical trial and to form a rational intention in the light of the facts.
    2. Male or female patients aged ≥18 years old.
    3. The patient has at least one implant in the oral cavity with clinical and radiographical signs of peri-implantitis. In the affected implant, at least one of the four aspect measured (mesio-buccal, mid-buccal, disto-buccal and mid-lingual) must show radiographic evidence of bone loss of at least 3 mm from mplant shoulder, and at least 2 mm distal and mesial supporting bone left from the apex to the coronal direction, in combination with bleeding and/or suppuration on probing and a peri-implant Probing Depth (PD) of 5-8 mm.
    4. The implants have been in function more than 2 years.
    5. Females of childbearing potential must be non-pregnant and non-lactating at entry and agree to use an adequate method of birth control during the study.
    E.4Principal exclusion criteria
    1. History of allergic reaction to Chlorhexidine.
    2. Active Periodontitis which required definitive treatment.
    3. Presence of soft or hard tissue tumours of the oral cavity.
    4. Patients treated with systemic antibiotic therapy or periodontal/mechanical/local delivery therapy within 6 weeks prior to study entry and throughout the study duration. In case the investigator advises the patient that antibiotic therapy is required during the course of the study, the patient should be excluded from further participation.
    5. Patients with uncontrolled diabetes, of any type, and/or patients with HbA1c test value >7.5% dated 3 months prior to the screening visit.
    6. Drug and alcohol abuse.
    E.5 End points
    E.5.1Primary end point(s)
    At week 24, compared to baseline, the mean probing Pocket Depth (PD) reductions (absolute change) for the selected target implant/s will be used as the primary efficacy endpoint.
    E.5.1.1Timepoint(s) of evaluation of this end point
    For the Primary End point the time-point for evaluation is the Last study visit (week 24).
    E.5.2Secondary end point(s)
    • PD measurement at week 24 compared to baseline in patients with baseline PD measurement of 6-8 mm inclusive.
    • Bleeding on Probing (BOP) measurements at week 16 and 24 compared to baseline.
    • PD measurement at week 16 compared to baseline.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For the Secondary End point the time-point for evaluation will be week 24 and week 16.
    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 Yes
    E.6.4Safety Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    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
    Subgingival debridement
    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 Yes
    E.8.5.1Number of sites anticipated in the EEA2
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Germany
    Israel
    United Kingdom
    United States
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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.1.3Elderly (>=65 years) Yes
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 246
    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 Decision2014-07-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-01-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-26
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