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    Clinical Trial Results:
    The Efficacy and Safety of Chlorhexidine Gluconate Chip (PerioChip®) in Therapy of Peri-implantitis

    Summary
    EudraCT number
    		 2013-000383-28
    Trial protocol
    		 GB   DE  
    Global end of trial date
    26 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jun 2021
    First version publication date
    02 Jun 2021
    Other versions
    Summary report(s)
    		 CLI/016P Synopsis

    Trial information

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    Trial identification
    Sponsor protocol code
    CLI/016P
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02080403
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dexcel Pharma Technologies Ltd
    Sponsor organisation address
    1 Dexcel St, Or-Akiva,, Israel, 3060000
    Public contact
    Dexcel Clinical Trial Information, Dexcel Pharma GmbH, 49 6023 94800,
    Scientific contact
    Dexcel Clinical Trial Information, Dexcel Pharma GmbH, 49 6023 94800,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Oct 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Jun 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To assess the efficacy of Chlorhexidine gluconate chip (PerioChip®) versus Subgingival debridement in Peri-implantitis patients.
    Protection of trial subjects
    Informed consent, Patient confidentiality, Monitoring the participant closely during the study
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    19 Aug 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 21
    Country: Number of subjects enrolled
    Germany: 23
    Country: Number of subjects enrolled
    Israel: 58
    Country: Number of subjects enrolled
    United States: 188
    Worldwide total number of subjects
    290
    EEA total number of subjects
    23
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    156
    From 65 to 84 years
    131
    85 years and over
    3

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 10 sites: 6 in US, 2 in Isreal, 1 in Germany and 1 in UK

    Pre-assignment
    Screening details
    		 Study subjects had to meet the inclusion/exclusion criteria

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Single blind
    Roles blinded
    		 Assessor [1]
    Blinding implementation details
    The clinicians that performed the pocket measurments were blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 PerioChip
    Arm description
    		 2.5 mg of chlorhexidine gluconate
    Arm type
    		 Experimental

    Investigational medicinal product name
    PerioChip
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Periodontal insert
    Routes of administration
    Dental use
    Dosage and administration details
    Up to 2 PerioChips may have been inserted into each target implant, for a maximum chlorhexidine gluconate dosage of 5 mg per implant. The maximum chlorhexidine gluconate dosage for a single patient across all implants was 10 mg (up to 4 PerioChips)

    Arm title
    		 Control
    Arm description
    		 Mechanical Subgingival Debridement
    Arm type
    		 standart of care

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Notes
    [1] - The roles blinded appear inconsistent with a simple blinded trial.
    Justification: The study used a single-blind masking design, in which patients and clinicians responsible for administering treatment (ie, placing PerioChips in the periodontal pockets and/or performing subgingival debridement) were aware of treatment arm assignments but separate clinicians who were not aware of treatment arm assignments were responsible for performing the other study assessments.
    Number of subjects in period 1
    		PerioChip Control
    Started
    146
    144
    Completed
    131
    132
    Not completed
    15
    12
         Adverse event, serious fatal
    2
    2
         Consent withdrawn by subject
    5
    1
         Adverse event, non-fatal
    4
    2
         Pregnancy
    -
    1
         Lost to follow-up
    2
    -
         Protocol deviation
    2
    6

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 290 290
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 156 156
        From 65-84 years
    		 131 131
        85 years and over
    		 3 3
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 62.6 ( 11.38 ) -
    Gender categorical
    Units: Subjects
        Female
    		 172 172
        Male
    		 118 118
    Race
    Units: Subjects
        Asian
    		 13 13
        Black or African American
    		 13 13
        White
    		 244 244
        Other
    		 20 20

    End points

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    End points reporting groups
    Reporting group title
    PerioChip
    Reporting group description
    		 2.5 mg of chlorhexidine gluconate

    Reporting group title
    Control
    Reporting group description
    		 Mechanical Subgingival Debridement

    Subject analysis set title
    By-Pocket Analysis (PerioChip)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    By-pocket analysis of ITT population (PerioChip)

    Subject analysis set title
    By-Pocket Analysis (Control)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    By-pocket analysis of ITT Population (Control)

    Subject analysis set title
    Number of implants at Week 16 (PerioChip)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Number of implants at Week 16 in the ITT population (PerioChip)

    Subject analysis set title
    Number of implants at Week 16 (Control)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Number of implants at Week 16 in the ITT population (Control)

    Subject analysis set title
    Number of implants at Week 24 (PerioChip)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Number of implants at Week 24 in the ITT population (PerioChip)

    Subject analysis set title
    Number of implants at Week 24 (Control)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Number of implants at Week 24 in the ITT population (Control)

    Primary: Mean Pocket Depth reduction (absolute change) for the selected target implant(s) at Week 24 compared to Baseline

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    End point title
    		 Mean Pocket Depth reduction (absolute change) for the selected target implant(s) at Week 24 compared to Baseline
    End point description
    End point type
    Primary
    End point timeframe
    Baseline to Week 24
    End point values
    		 By-Pocket Analysis (PerioChip) By-Pocket Analysis (Control)
    Number of subjects analysed
    180
    174
    Units: mm
        arithmetic mean (standard deviation)
    -1.69 ( 1.18 )
    -1.51 ( 1.16 )
    Statistical analysis title
    		 Anaylsis of Primary Efficacy Endpoint
    Comparison groups
    By-Pocket Analysis (PerioChip) v By-Pocket Analysis (Control)
    Number of subjects included in analysis
    354
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Mixed linear model
    Confidence interval

    Secondary: Pocket Depth measurement at Week 16 compared to Baseline

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    End point title
    		 Pocket Depth measurement at Week 16 compared to Baseline
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    		 By-Pocket Analysis (PerioChip) By-Pocket Analysis (Control)
    Number of subjects analysed
    179
    166
    Units: mm
        arithmetic mean (standard deviation)
    -1.36 ( 1.22 )
    -1.41 ( 1.12 )
    No statistical analyses for this end point

    Secondary: Pocket Depth measurement at Week 24 compared to Baseline in patients with a Baseline PD measurement of 6 to 8 mm (inclusive)

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    End point title
    		 Pocket Depth measurement at Week 24 compared to Baseline in patients with a Baseline PD measurement of 6 to 8 mm (inclusive)
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    		 PerioChip Control
    Number of subjects analysed
    141
    130
    Units: mm
        arithmetic mean (standard deviation)
    -1.77 ( 1.25 )
    -1.65 ( 1.18 )
    No statistical analyses for this end point

    Secondary: Bleeding on probing (BOP) measurements at Weeks 16 compared to Baseline

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    End point title
    		 Bleeding on probing (BOP) measurements at Weeks 16 compared to Baseline
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 16
    End point values
    		 Number of implants at Week 16 (PerioChip) Number of implants at Week 16 (Control)
    Number of subjects analysed
    179
    165
    Units: Number of patients
        BOP to BOP
    96
    82
        BOP to no BOP
    76
    73
        No BOP to BOP
    3
    2
        No BOP to no BOP
    4
    8
    No statistical analyses for this end point

    Secondary: Bleeding on probing (BOP) measurements at Week 24 compared to Baseline

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    End point title
    		 Bleeding on probing (BOP) measurements at Week 24 compared to Baseline
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline to Week 24
    End point values
    		 Number of implants at Week 24 (PerioChip) Number of implants at Week 24 (Control)
    Number of subjects analysed
    180
    173
    Units: Number of patients
        BOP to BOP
    83
    86
        BOP to no BOP
    90
    77
        No BOP to BOP
    2
    3
        No BOP to no BOP
    5
    7
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Baseline through Week 24
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    Safety
    Reporting group description
    		 -

    Serious adverse events
    		 Safety
    Total subjects affected by serious adverse events
         subjects affected / exposed
    7 / 290 (2.41%)
         number of deaths (all causes)
    2
         number of deaths resulting from adverse events
    2
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Colon cancer
         subjects affected / exposed
    1 / 290 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Cardiac disorders
    Acute myocardial infarction
         subjects affected / exposed
    1 / 290 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Ventricular tachycardia
         subjects affected / exposed
    1 / 290 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Nervous system disorders
    Facial paralysis
         subjects affected / exposed
    1 / 290 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    General disorders and administration site conditions
    Death
         subjects affected / exposed
    2 / 290 (0.69%)
         occurrences causally related to treatment / all
    0 / 2
         deaths causally related to treatment / all
    0 / 2
    Musculoskeletal and connective tissue disorders
    Forearm fracture
         subjects affected / exposed
    1 / 290 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Infections and infestations
    Diverticulitis
         subjects affected / exposed
    1 / 290 (0.34%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 2%
    Non-serious adverse events
    		 Safety
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    68 / 290 (23.45%)
    Injury, poisoning and procedural complications
    Tooth repair
         subjects affected / exposed
    5 / 290 (1.72%)
         occurrences all number
    8
    Aphthous ulcer
         subjects affected / exposed
    4 / 290 (1.38%)
         occurrences all number
    6
    Artificial crown procedure
         subjects affected / exposed
    3 / 290 (1.03%)
         occurrences all number
    3
    Tooth fracture
         subjects affected / exposed
    3 / 290 (1.03%)
         occurrences all number
    4
    General disorders and administration site conditions
    Implant site pain
         subjects affected / exposed
    12 / 290 (4.14%)
         occurrences all number
    16
    Post procedural discomfort
         subjects affected / exposed
    6 / 290 (2.07%)
         occurrences all number
    8
    Gingivitis
         subjects affected / exposed
    4 / 290 (1.38%)
         occurrences all number
    8
    Toothache
         subjects affected / exposed
    4 / 290 (1.38%)
         occurrences all number
    5
    Gingival bleeding
         subjects affected / exposed
    3 / 290 (1.03%)
         occurrences all number
    4
    Gingival pain
         subjects affected / exposed
    3 / 290 (1.03%)
         occurrences all number
    3
    Headache
         subjects affected / exposed
    3 / 290 (1.03%)
         occurrences all number
    3
    Hypersensitivity
         subjects affected / exposed
    3 / 290 (1.03%)
         occurrences all number
    3
    Implant site swelling
         subjects affected / exposed
    3 / 290 (1.03%)
         occurrences all number
    3
    Pharyngitis
         subjects affected / exposed
    3 / 290 (1.03%)
         occurrences all number
    3
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    9 / 290 (3.10%)
         occurrences all number
    15

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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