Anterior Open Bite Clinical Trial
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.
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.
Status | Not yet recruiting |
Enrollment | 30 |
Est. completion date | May 1, 2023 |
Est. primary completion date | April 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 11 Years |
Eligibility | 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Reem Hatem Shams |
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
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Primary | 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. | 12 months | |
Secondary | 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 | 12 months | |
Secondary | 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. |
1 month |
Status | Clinical Trial | Phase | |
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Completed |
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