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
About this trial
This is an interventional treatment trial for Anterior Open Bite
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.
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
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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