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    Clinical Trial Results:
    Study assessing if oxytocin can be used as premedication for anxious patients in dentistry.

    Summary
    EudraCT number
    		 2022-003117-11
    Trial protocol
    		 CZ  
    Global end of trial date
    14 Jan 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    10 Feb 2026
    First version publication date
    10 Feb 2026
    Other versions
    Summary report(s)
    		 Statistics
    statistics2

    Trial information

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    Trial identification
    Sponsor protocol code
    BCD101
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Dentlabe s.r.o.
    Sponsor organisation address
    Namesti Svobody 274, Kolin, Czechia,
    Public contact
    Ondřej Kohout, Dentlabe s.r.o., +420 731885434, ondrej.kohout7@gmail.com
    Scientific contact
    Ondřej Kohout, Dentlabe s.r.o., +420 731885434, ondrej.kohout7@gmail.com
    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
    28 Jan 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Jan 2025
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jan 2025
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To assess if oxytocin can be used as premedication in dentistry
    Protection of trial subjects
    Pain and distress were minimised by proffesional attitude to every subject. Every procedure was performed with local anaesthesia. The whole study was aimed at releaving pain and stress from dental treament.
    Background therapy
    		 Every patient/subject got local anaesthesia. Septanest or Supracain, depends on localisation (upper or lower jaw). Both contain the same drugs; articaini hydrochloridum and epinephrini hydrochloridum. Dose 1,5 - 3ml.
    Evidence for comparator
    		 "Vincentka" mineral water was used as comparator to oxytocin. Study is single-blinded.
    Actual start date of recruitment
    07 Aug 2024
    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
    Czechia: 24
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 recruitment period : 08/07/2024 to 01/28/2025 Czechia *Men and women, *Age 18 – 65 years, *Diagnosis of odontophobia (Dg F40.2) or mentally healthy persons who are afraid of dental procedures *Patients undergoing endodontic treatment

    Pre-assignment
    Screening details
    		 Exclusion criteria: * Allergy to oxytocin or any LATEX component * Scars or previous surgical procedures on the uterus * Use of prostaglandins 6 hours before * Tendency to chest pain due to heart or circulatory problems *Arrhythmia, esp. long QT syndrome, * Serious kidney and liver disease, * Risk of thrombolia *Pregnancy

    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
    		 Subject

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 placebo arm
    Arm description
    		 placebo arm
    Arm type
    		 Placebo

    Investigational medicinal product name
    Vincentka
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal drops, solution
    Routes of administration
    Intranasal use
    Dosage and administration details
    1 drop to each nostril

    Arm title
    		 oxytocin arm
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Oxytocin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Nasal drops, solution
    Routes of administration
    Intranasal use
    Dosage and administration details
    1 drop to each nostril

    Number of subjects in period 1
    		placebo arm oxytocin arm
    Started
    12
    12
    Completed
    12
    12

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 The whole group of 24 subjects

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 24 24
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 24 24
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36 ( 0 ) -
    Gender categorical
    Units: Subjects
        Female
    		 13 13
        Male
    		 11 11
    Subject analysis sets

    Subject analysis set title
    Analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The whole set od 24 subjects

    Subject analysis sets values
    		 Analysis
    Number of subjects
    24
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    24
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    ( )
    Gender categorical
    Units: Subjects
        Female
        Male

    End points

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    End points reporting groups
    Reporting group title
    placebo arm
    Reporting group description
    		 placebo arm

    Reporting group title
    oxytocin arm
    Reporting group description
    		 -

    Subject analysis set title
    Analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The whole set od 24 subjects

    Primary: Change in BDI score

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    End point title
    		 Change in BDI score
    End point description
    Difference of BDI score at start and at the end of study.
    End point type
    Primary
    End point timeframe
    Difference of BDI score at start and at the end of study.
    End point values
    		 placebo arm oxytocin arm Analysis
    Number of subjects analysed
    12
    12
    24
    Units: points
    12
    12
    24
    Statistical analysis title
    		 Statistics
    Comparison groups
    placebo arm v oxytocin arm
    Number of subjects included in analysis
    24
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 5
    Method
    		 t-test, 1-sided
    Confidence interval

    Primary: Heart rate

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    End point title
    		 Heart rate [1]
    End point description
    Difference of heart rate at start and at the end of study.
    End point type
    Primary
    End point timeframe
    Difference of heart rate at start and at the end of study.
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are errors in statistical analysis. Impossible to select arms... So i add attachment instead
    End point values
    		 Analysis
    Number of subjects analysed
    24
    Units: beats
    24
    Attachments
    		 Untitled (Filename: phd oxytocin eng.xlsx)
    No statistical analyses for this end point

    Primary: Blood pressure

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    End point title
    		 Blood pressure [2]
    End point description
    Difference of blood pressure at start and at the end of study.
    End point type
    Primary
    End point timeframe
    Difference of blood pressure at start and at the end of study.
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are errors in statistical analysis. Impossible to select arms... So i add attachment instead
    End point values
    		 Analysis
    Number of subjects analysed
    24 [3]
    Units: mmHg
    24
    Attachments
    		 Untitled (Filename: phd oxytocin eng.xlsx)
    Notes
    [3] - 24
    No statistical analyses for this end point

    Primary: Skin temperature

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    End point title
    		 Skin temperature [4]
    End point description
    Difference of skin temperature at start and at the end of study.
    End point type
    Primary
    End point timeframe
    Difference of skin temperature at start and at the end of study.
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: There are errors in statistical analysis. Impossible to select arms... So i add attachment instead
    End point values
    		 Analysis
    Number of subjects analysed
    24 [5]
    Units: °C
    24
    Attachments
    		 Untitled (Filename: phd oxytocin eng.xlsx)
    Notes
    [5] - 24
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    08/07/2024 - 01/28/2025
    Adverse event reporting additional description
    Subjects were observed, asked after procedure and asked the next day about adverse events.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 SUKL
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Adverse event reporting
    Reporting group description
    		 -

    Serious adverse events
    		 Adverse event reporting
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Adverse event reporting
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    4 / 24 (16.67%)
    Nervous system disorders
    gagging
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Eye disorders
    lachrymation
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Gastrointestinal disorders
    burning of the throat mucosa
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1
    Respiratory, thoracic and mediastinal disorders
    burning of the nasal mucosa
         subjects affected / exposed
    1 / 24 (4.17%)
         occurrences all number
    1

    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.
    early termination leading to a smaller number of subjects than expected, but enough to be assesesd
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    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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