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Palatal Crib Versus Bonded Spurs in Early Treatment of Anterior Open Bite Caused by Non-nutritive Sucking Habits: RCT

Primary Purpose

Anterior Open Bite

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Palatal Crib
bonded spur
Sponsored by
Reem Hatem Shams
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anterior Open Bite

Eligibility Criteria

6 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Children with nonnutritive sucking habits and/or tongue thrusting from 6 years to 11 years old.
  2. Angle Class I malocclusions.
  3. Anterior open bite equal to or greater than 1 mm.
  4. Maxillary and mandibular permanent central incisors fully erupted (children in the first transitional period were eligible for treatment when the maxillary lateral incisors were beginning to erupt, and the maxillary central incisors were still showing an open bite).

Exclusion Criteria:

  1. Children with loss of permanent teeth.
  2. Crowding, maxillary constriction, or posterior crossbites.
  3. Previous orthodontic treatment.
  4. Presence of craniofacial anomalies or syndromes.
  5. Tooth agenesis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    control group

    experimental group

    Arm Description

    the group have open bite caused by non-nutritive sucking habits and treat them with palatal crib.

    the group have open bite caused by by non-nutritive sucking habit and treat them with bonded spur.

    Outcomes

    Primary Outcome Measures

    Overbite distance correction in millimeter
    Digital dental model will be scanned using medit software to detect the changes that occur in the vertical distance ( in millimeter ) between incisal edges of the most erupted maxillary and mandibular central incisors in relation to the occlusal plane.

    Secondary Outcome Measures

    Changes in maxillary mandibular plane angle
    standardised lateral cephalometric radiographs will be taken, and the variables will be digitally traced using Dolphin Imaging Software Version 11.5
    Patient acceptance
    The questionnaire is consisted of 5 questions and has space for additional patient comments. The variables in the first four questions will assess speaking, eating, esthetics, and pain. The rating scale that will be used to quantify the effect of the spurs and the palatal crib on these variables 1 (easy), 2 (neutral), and 3 (difficult). The 5th question on the survey will assess the time needed by the patients to adjust the presence of the two appliances. Possible answers are 2 days or less, 1 week, 2 weeks, and longer.

    Full Information

    First Posted
    March 22, 2022
    Last Updated
    April 1, 2022
    Sponsor
    Reem Hatem Shams
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05313399
    Brief Title
    Palatal Crib Versus Bonded Spurs in Early Treatment of Anterior Open Bite Caused by Non-nutritive Sucking Habits: RCT
    Official Title
    Skeletal and Dentoalveolar Effects of Palatal Crib Versus Bonded Spurs in Early Treatment of Anterior Open Bite Caused by Non-nutritive Sucking Habits: A Randomised Clinical Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2022 (Anticipated)
    Primary Completion Date
    April 1, 2023 (Anticipated)
    Study Completion Date
    May 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Reem Hatem Shams

    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
    The study evaluates the effects of palatal crib versus bonded spurs in the early treatment of anterior open bite caused by non-nutritive sucking habits.
    Detailed Description
    Habit is an unintentionally performed repeated activity. Development of habit is considered a part of the natural progression of maturation in children between infancy and three years of age, after this period, it is assumed to be unnatural. The most familiar and earliest noted habit is thumb sucking. It develops during infancy as a rooting reflex, after it ceases around three years of age . Thumb sucking is defined as the placement of the thumb or one or more fingers in different depths into the mouth ). It emerges in two forms: nutritive and non-nutritive, where the first gives nourishment and the second implements a sense of security and amenity. It is common in children and is reported to be harmless for up to five years of age . There is an association between the habit of thumb sucking and the development of skeletal open-bite among children. Anterior open bites (AOBs) are defined as an occlusion in which the lower incisors are not overlapped in the vertical plane by the upper incisors and do not occlude with them when the posterior teeth are in maximum intercuspation . Anterior open bite due to thumb sucking, and a secondary tongue thrust exaggerates the condition . If identified early, this can be avoided and appropriate treatment is delivered. Approaches for habit intervention include counseling, positive reinforcement, a calendar with rewards, an adhesive bandage, bitter nail polish, long sleeves, and appliance therapy. It is recommended to start with the least invasive methods before using habit-breaking appliances. Habit-breaking appliances are either fixed or removable. Fixed appliance therapy may be considered after the age of 4 years. Appliances consisting of cribs in the anterior region are very efficient as reminders and physical restrainers . The palatal crib works as an obstacle in non-nutritive sucking and maintains the tongue in a more retruded position, halting its interposition between the incisors. Spur appliances change tongue action, close the open bite, and boost treatment stability, as it induces a permanent modification of the tongue's anterior rest posture by altering orofacial function, resulting in a change in form. Finally, the spur adjusts the sensory input to the brain. This proprioceptive change leads to an altered motor response, resulting in a new normal tongue rest posture (change in function) that allows the incisors to erupt.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anterior Open Bite

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    control group
    Arm Type
    Active Comparator
    Arm Description
    the group have open bite caused by non-nutritive sucking habits and treat them with palatal crib.
    Arm Title
    experimental group
    Arm Type
    Experimental
    Arm Description
    the group have open bite caused by by non-nutritive sucking habit and treat them with bonded spur.
    Intervention Type
    Device
    Intervention Name(s)
    Palatal Crib
    Intervention Description
    An intraoral appliance approach can be used as an adjunct method to stop the habit. Appliances consisting of cribs in the anterior region are very efficient as reminders and physical restrainers. The palatal crib works as an obstacle in non-nutritive sucking and maintains the tongue in a more retruded position, halting its interposition between the incisors.
    Intervention Type
    Device
    Intervention Name(s)
    bonded spur
    Intervention Description
    Spur appliances change tongue action, close the open bite, and boost treatment stability, as it induces a permanent modification of the tongue's anterior rest posture by altering orofacial function, resulting in a change in form. Finally, the spur adjusts the sensory input to the brain. This proprioceptive change leads to an altered motor response, resulting in a new normal tongue rest posture (change in function) that allows the incisors to erupt
    Primary Outcome Measure Information:
    Title
    Overbite distance correction in millimeter
    Description
    Digital dental model will be scanned using medit software to detect the changes that occur in the vertical distance ( in millimeter ) between incisal edges of the most erupted maxillary and mandibular central incisors in relation to the occlusal plane.
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Changes in maxillary mandibular plane angle
    Description
    standardised lateral cephalometric radiographs will be taken, and the variables will be digitally traced using Dolphin Imaging Software Version 11.5
    Time Frame
    12 months
    Title
    Patient acceptance
    Description
    The questionnaire is consisted of 5 questions and has space for additional patient comments. The variables in the first four questions will assess speaking, eating, esthetics, and pain. The rating scale that will be used to quantify the effect of the spurs and the palatal crib on these variables 1 (easy), 2 (neutral), and 3 (difficult). The 5th question on the survey will assess the time needed by the patients to adjust the presence of the two appliances. Possible answers are 2 days or less, 1 week, 2 weeks, and longer.
    Time Frame
    1 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    6 Years
    Maximum Age & Unit of Time
    11 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Children with nonnutritive sucking habits and/or tongue thrusting from 6 years to 11 years old. Angle Class I malocclusions. Anterior open bite equal to or greater than 1 mm. Maxillary and mandibular permanent central incisors fully erupted (children in the first transitional period were eligible for treatment when the maxillary lateral incisors were beginning to erupt, and the maxillary central incisors were still showing an open bite). Exclusion Criteria: Children with loss of permanent teeth. Crowding, maxillary constriction, or posterior crossbites. Previous orthodontic treatment. Presence of craniofacial anomalies or syndromes. Tooth agenesis.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Reem H Shams, B.D.S
    Phone
    01099898731
    Ext
    002
    Email
    reem.shamseldin@dentistry.cu.edu.eg
    First Name & Middle Initial & Last Name or Official Title & Degree
    maii M Ali, Lecturer
    Phone
    01012632608
    Ext
    022
    Email
    maii.ali@dentistry.cu.edu.eg
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmed H Elkhadem, Ass. professor
    Organizational Affiliation
    Cairo University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    26719946
    Citation
    Leite JS, Matiussi LB, Salem AC, Provenzano MG, Ramos AL. Effects of palatal crib and bonded spurs in early treatment of anterior open bite: A prospective randomized clinical study. Angle Orthod. 2016 Sep;86(5):734-9. doi: 10.2319/031815-170.1. Epub 2015 Dec 31.
    Results Reference
    background
    Links:
    URL
    https://pubmed.ncbi.nlm.nih.gov/PMC8600830/
    Description
    correction of open bite caused by non-nutritive sucking habit by using palatal crib and bonded spur

    Learn more about this trial

    Palatal Crib Versus Bonded Spurs in Early Treatment of Anterior Open Bite Caused by Non-nutritive Sucking Habits: RCT

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