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Resin Infiltration Treatment Versus a Combined Treatment With Microabrasion for the Management of MIH Affected Incisors

Primary Purpose

Molar Incisor Hypomineralization

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Resin infiltration and microabrasion for MIH-affected incisors
Resin infiltration for MIH-affected incisors
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Molar Incisor Hypomineralization

Eligibility Criteria

7 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Cooperative children aged between 7-16 years old
  2. Children with MIH having enamel opacity involving at least one permanent incisor
  3. MIH- affected incisors which did not receive any previous treatment
  4. 1/3 of the crown should be visible in the oral cavity
  5. Lesions size should be more than 1mm
  6. Healthy children

Exclusion Criteria:

  1. Children with systemic diseases, allergies or any dental or facial anomaly other than MIH
  2. Children aged < 7 or > 16 years old
  3. Uncooperative children
  4. MIH patients without the affection of the incisors or with compromised incisor esthetics due to tooth surface loss, traumatic dental injury or caries
  5. MIH incisors which already received any kind of treatment
  6. Lesions which are smaller than 1mm in size

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Resin infiltration group

    Microabrasion + resin infiltration group

    Arm Description

    Enamel lesions for this group will be treated only by resin infiltration.

    Enamel lesions for this group will be treated first by microabrasion followed by resin infiltration.

    Outcomes

    Primary Outcome Measures

    Change in the aesthetics and amount of color masking of the lesion
    Vita Easyshade Advance® spectrophotometer (Vita Zahnfabrik, Sackingen, Germany) will be used to evaluate the change in color of the teeth selected in the study before and after the treatment. L*, a*, and b* values will be recorded for each tooth based on the CIEL*a* b* color space. The value of color differences or color masking (∆E) will be clinically evaluated by the formula ∆E=[(∆L*)2+(∆a*)2+(∆b*). Color readings will be taken before, immediately after, 1, 3, 6, and 12 months after treatment.

    Secondary Outcome Measures

    Change in the patient's oral health related quality of life following the treatment: Child Perceptions Questionnaire CPQ 8-10/11-14
    It includes evaluating the patient's Oral Health Related Quality of life (OHRQoL) before and after treatment which is measured as difference in the scores of the Child Perceptions Questionnaire CPQ 8-10/11-14 before and after treatment. There are 36 items included in the questionnaire covering four different domains: oral symptoms, function related limitations as well as emotional and social well-being. The participants should answer regarding the frequency of certain events in the last six months. There are 5 responses to choose from: 0 = Never, 1 = Once or twice, 2 = Sometimes, 3 = Often and 4 = Every day or almost every day. The total score should range from 0 to 144. Higher scores indicate low oral health related quality of life (OHRQoL).

    Full Information

    First Posted
    July 2, 2020
    Last Updated
    July 14, 2020
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04471571
    Brief Title
    Resin Infiltration Treatment Versus a Combined Treatment With Microabrasion for the Management of MIH Affected Incisors
    Official Title
    A Comparison of the Effectiveness of Resin Infiltration Treatment Versus a Combined Treatment of Microabrasion and Resin Infiltration for the Management of Affected Incisors in Molar Incisor Hypomineralization (MIH) Cases
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2021 (Anticipated)
    Primary Completion Date
    January 2022 (Anticipated)
    Study Completion Date
    June 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

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

    5. Study Description

    Brief Summary
    The prevalence of molar incisor hypomineralization is relatively high. It has been reported that MIH-affected children experience a wide range of negative impacts because of having visible enamel opacities on their incisors whether these teeth show post eruptive breakdown or not. The management of MIH is challenging with a broad spectrum of treatment modalities being available. However, there are no clear guidelines available to aid in clinical decision making. Possible treatment options for anterior teeth with MIH include: Microabrasion, resin infiltration, tooth bleaching, etch-bleach and seal technique and composite restorations or veneers. It is believed that these methods could be used alone or in a combination of methods to achieve better aesthetic results. For MIH affected-incisors microabrasion and resin infiltration are acceptable treatment options which could be used alone or in a combination. Accordingly, the aim of this study is to compare the clinical outcomes of using resin infiltration either alone or combined with microabrasion for the management of MIH affected incisors.
    Detailed Description
    The study will be conducted on a dental unit in postgraduate clinic of Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Cairo University, Egypt.The primary hypothesis of this study is that a resin infiltration and microabrasion combined treatment will result in better clinical outcomes than using resin infiltration alone. All treatment procedures will be carried out by the principal investigator. 36 patients will be included in the study. The teeth will be randomized into two groups according to the intervention. The study involves two types of interventions: Group 1 (resin infiltration): The treatment will follow the manufacturer's instructions (Icon, DMG, Hamburg, Germany). The procedure involves the application of Icon-Etch, Icon-Dry as well as Icon-Infiltrant. Followed by removal of excess and then polishing of the treated surfaces. Group 2 (Micro-abrasion followed by resin infiltration): The Micro-abrasion agent (Opalustre, Ultradent, South Jordan, UT, USA) will be applied to the tooth for 60 seconds using a standard rubber cup attached to a low speed hand piece followed by rinsing the tooth surface with water for 20 seconds. This procedure will be repeated up to 5 times. Resin infiltration will then be carried out as discussed before. Vita Easyshade Advance® spectrophotometer (Vita Zahnfabrik, Sackingen, Germany) will be used to evaluate the masking color of the teeth selected in the study. Measurements will be taken before, immediately after, 1 month, 3 months, 6 months and 12 months after treatment. A standardized Photograph will be taken at 5 different times (before treatment, immediately afterwards, one month, 6 months and 12 months after treatment with the exact same camera and conditions. The images collected will be analyzed and evaluated by 2 different dentists.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Molar Incisor Hypomineralization

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    two-arm parallel group randomized controlled trial
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Masking Description
    Selection bias: will be overcome by randomization and allocation concealment. Performance bias: will be overcome by standardized method of application by single operator. Detection bias: will be overcome by blinding of the outcome assessor. Reporting bias: All the outcomes will be reported and published.
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Resin infiltration group
    Arm Type
    Active Comparator
    Arm Description
    Enamel lesions for this group will be treated only by resin infiltration.
    Arm Title
    Microabrasion + resin infiltration group
    Arm Type
    Experimental
    Arm Description
    Enamel lesions for this group will be treated first by microabrasion followed by resin infiltration.
    Intervention Type
    Other
    Intervention Name(s)
    Resin infiltration and microabrasion for MIH-affected incisors
    Intervention Description
    MIH-affected incisors will be treated with microabrasion followed by resin infiltration as a combined treatment
    Intervention Type
    Other
    Intervention Name(s)
    Resin infiltration for MIH-affected incisors
    Intervention Description
    MIH-affected incisors will be treated with resin infiltration alone
    Primary Outcome Measure Information:
    Title
    Change in the aesthetics and amount of color masking of the lesion
    Description
    Vita Easyshade Advance® spectrophotometer (Vita Zahnfabrik, Sackingen, Germany) will be used to evaluate the change in color of the teeth selected in the study before and after the treatment. L*, a*, and b* values will be recorded for each tooth based on the CIEL*a* b* color space. The value of color differences or color masking (∆E) will be clinically evaluated by the formula ∆E=[(∆L*)2+(∆a*)2+(∆b*). Color readings will be taken before, immediately after, 1, 3, 6, and 12 months after treatment.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Change in the patient's oral health related quality of life following the treatment: Child Perceptions Questionnaire CPQ 8-10/11-14
    Description
    It includes evaluating the patient's Oral Health Related Quality of life (OHRQoL) before and after treatment which is measured as difference in the scores of the Child Perceptions Questionnaire CPQ 8-10/11-14 before and after treatment. There are 36 items included in the questionnaire covering four different domains: oral symptoms, function related limitations as well as emotional and social well-being. The participants should answer regarding the frequency of certain events in the last six months. There are 5 responses to choose from: 0 = Never, 1 = Once or twice, 2 = Sometimes, 3 = Often and 4 = Every day or almost every day. The total score should range from 0 to 144. Higher scores indicate low oral health related quality of life (OHRQoL).
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Cooperative children aged between 7-16 years old Children with MIH having enamel opacity involving at least one permanent incisor MIH- affected incisors which did not receive any previous treatment 1/3 of the crown should be visible in the oral cavity Lesions size should be more than 1mm Healthy children Exclusion Criteria: Children with systemic diseases, allergies or any dental or facial anomaly other than MIH Children aged < 7 or > 16 years old Uncooperative children MIH patients without the affection of the incisors or with compromised incisor esthetics due to tooth surface loss, traumatic dental injury or caries MIH incisors which already received any kind of treatment Lesions which are smaller than 1mm in size
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Shehab El-Din
    Phone
    201066695543
    Email
    dinanasrshehab@hotmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shehab El-Din
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30287963
    Citation
    Almuallem Z, Busuttil-Naudi A. Molar incisor hypomineralisation (MIH) - an overview. Br Dent J. 2018 Oct 5. doi: 10.1038/sj.bdj.2018.814. Online ahead of print.
    Results Reference
    background
    PubMed Identifier
    30388743
    Citation
    Hasmun N, Lawson J, Vettore MV, Elcock C, Zaitoun H, Rodd H. Change in Oral Health-Related Quality of Life Following Minimally Invasive Aesthetic Treatment for Children with Molar Incisor Hypomineralisation: A Prospective Study. Dent J (Basel). 2018 Nov 1;6(4):61. doi: 10.3390/dj6040061.
    Results Reference
    background

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    Resin Infiltration Treatment Versus a Combined Treatment With Microabrasion for the Management of MIH Affected Incisors

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