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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anterior Open Bite
• Intervention / Treatment: Device: Palatal Crib; Device: bonded spur

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Reem H Shams, B.D.S; Phone Number: 002 01099898731; Email: reem.shamseldin@dentistry.cu.edu.eg
• Study Contact Backup: Name: maii M Ali, Lecturer; Phone Number: 022 01012632608; Email: maii.ali@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: control group; the group have open bite caused by non-nutritive sucking habits and treat them with palatal crib.	Device: Palatal Crib; 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.
Experimental: experimental group; the group have open bite caused by by non-nutritive sucking habit and treat them with bonded spur.	Device: bonded spur; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Reem Hatem Shams
• Investigators: Study Chair: Ahmed H Elkhadem, Ass. professor, Cairo University

Publications and helpful links

General Publications

• 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.

Helpful Links

• correction of open bite caused by non-nutritive sucking habit by using palatal crib and bonded spur

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): April 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: April 1, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 1, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Malocclusion; Open Bite
• Other Study ID Numbers: 457

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No