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Local Anesthesia in Molar Teeth With Molar Incisor Hypomineralization

Primary Purpose

Molar Incisor Hypomineralization

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Evaluation of cold test
Evaluation of electrical pulp test
Evaluation of pain during the treatment
Sponsored by
Didem Sakaryali
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Molar Incisor Hypomineralization focused on measuring Anesthesia, Cold test, Electrical pulp test

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy participants

Exclusion Criteria:

  • Not being cooperative during treatment procedure

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Placebo Comparator

    Arm Label

    MIH-effected carious first permanent molar teeth

    not MIH-effected carious first permanent molar teeth

    MIH-effected non-carious first permanent molar teeth

    not MIH-effected non-carious first permanent molar teeth

    Arm Description

    MIH-effected carious permanent first molar teeth were well-demarcated white/yellow or brown/yellow enamel opacities which is a sign for hypomineralization and asymptomatic which meant to be without any spontaneous pain or pain during eating or drinking, percussion or palpation tenderness, formation of abcess or fistula.

    The carious not MIH-effected teeth were only carious without any hypomineralize areas and asymptomatic which meant to be without any spontaneous pain or pain during eating or drinking, percussion or palpation tenderness, formation of abcess or fistula.

    MIH-effected teeth were carious permanent first molar teeth with well-demarcated white/yellow or brown/yellow enamel opacities which is a sign for hypomineralization and did not have any sign of caries.

    not any signs of being caries or hypomineralization.

    Outcomes

    Primary Outcome Measures

    Cold test results
    Visual Analog Scale for Pain was used to evaluate the cold tests for before and after the local anesthesia. Visual analog scale was used to rate the sensitivity level of patients with 6 different faces representing different levels of pain from "0=no pain" to "10=unbearable pain".
    Electrical pulp test results
    Electrical pulp test values at which patients felt sensitive were recorded.
    Pain during the treatment
    Visual Analog Scale for Pain was used to evaluate the pain during the treatment. Visual analog scale was used to rate the sensitivity level of patients with 6 different faces representing different levels of pain from "0=no pain" to "10=unbearable pain".

    Secondary Outcome Measures

    Full Information

    First Posted
    August 10, 2019
    Last Updated
    August 16, 2019
    Sponsor
    Didem Sakaryali
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04061096
    Brief Title
    Local Anesthesia in Molar Teeth With Molar Incisor Hypomineralization
    Official Title
    Effectiveness Of Local Anesthesia In Molar Teeth With Molar Incisor Hypomineralization-A Prospective Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2014 (Actual)
    Primary Completion Date
    May 1, 2018 (Actual)
    Study Completion Date
    May 1, 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Didem Sakaryali

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To compare responses to electrical pulp test (EPT) and cold test among molar incisor hypomineralization (MIH)-effected and not MIH-effected carious teeth before and after administration of local anesthesia for caries removal.
    Detailed Description
    Fifty carious permanent first molar teeth (25 MIH-effected, 25 not MIH-effected) were included. Firstly, radiographic caries depth, International Caries Detection and Assessment System (ICDAS) codes and MIH levels of teeth were recorded. Then, during the treatment, EPT and cold test were performed before and after the administration of local anesthesia. Visual Analog Scale for Pain was used to evaluate cold test and pain during treatment. When interpreting results, significancy level was stated for the values of p<0.05.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Molar Incisor Hypomineralization
    Keywords
    Anesthesia, Cold test, Electrical pulp test

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Masking Description
    no need
    Allocation
    Non-Randomized
    Enrollment
    38 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MIH-effected carious first permanent molar teeth
    Arm Type
    Active Comparator
    Arm Description
    MIH-effected carious permanent first molar teeth were well-demarcated white/yellow or brown/yellow enamel opacities which is a sign for hypomineralization and asymptomatic which meant to be without any spontaneous pain or pain during eating or drinking, percussion or palpation tenderness, formation of abcess or fistula.
    Arm Title
    not MIH-effected carious first permanent molar teeth
    Arm Type
    Active Comparator
    Arm Description
    The carious not MIH-effected teeth were only carious without any hypomineralize areas and asymptomatic which meant to be without any spontaneous pain or pain during eating or drinking, percussion or palpation tenderness, formation of abcess or fistula.
    Arm Title
    MIH-effected non-carious first permanent molar teeth
    Arm Type
    Placebo Comparator
    Arm Description
    MIH-effected teeth were carious permanent first molar teeth with well-demarcated white/yellow or brown/yellow enamel opacities which is a sign for hypomineralization and did not have any sign of caries.
    Arm Title
    not MIH-effected non-carious first permanent molar teeth
    Arm Type
    Placebo Comparator
    Arm Description
    not any signs of being caries or hypomineralization.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Evaluation of cold test
    Intervention Description
    Cold test evaluation to describe the sensitivity level of teeth due to induce the hydrodynamic forces in dentine tubules.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Evaluation of electrical pulp test
    Intervention Description
    Electrical pulp test evaluation to describe the sensitivity level of teeth due to induce the nerve fibers in pulp tissue.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Evaluation of pain during the treatment
    Intervention Description
    Describe the sensitivity level due to induce the hydrodynamic forces during treatment procedure.
    Primary Outcome Measure Information:
    Title
    Cold test results
    Description
    Visual Analog Scale for Pain was used to evaluate the cold tests for before and after the local anesthesia. Visual analog scale was used to rate the sensitivity level of patients with 6 different faces representing different levels of pain from "0=no pain" to "10=unbearable pain".
    Time Frame
    Time frame of cold test evaluation was aproximately 1 hour for each participant.
    Title
    Electrical pulp test results
    Description
    Electrical pulp test values at which patients felt sensitive were recorded.
    Time Frame
    Time frame of electrical pulp test evaluation was aproximately 1 hour for each participant.
    Title
    Pain during the treatment
    Description
    Visual Analog Scale for Pain was used to evaluate the pain during the treatment. Visual analog scale was used to rate the sensitivity level of patients with 6 different faces representing different levels of pain from "0=no pain" to "10=unbearable pain".
    Time Frame
    Pain during the treatment was evaluated for aproximately 1 hour for each participant.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy participants Exclusion Criteria: Not being cooperative during treatment procedure
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Didem Sakaryali, Asst.Prof.
    Organizational Affiliation
    Baskent University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The authors decided to share the information of this study after the study will be published in a scientific journal.

    Learn more about this trial

    Local Anesthesia in Molar Teeth With Molar Incisor Hypomineralization

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