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

NCT ID: NCT05313399

Last Updated: 2022-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2023-05-01

Brief Summary

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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

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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.

Conditions

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Anterior Open Bite

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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control group

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

Group Type ACTIVE_COMPARATOR

Palatal Crib

Intervention Type DEVICE

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 group

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

Group Type EXPERIMENTAL

bonded spur

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Reem Hatem Shams

OTHER

Sponsor Role lead

Responsible Party

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Reem Hatem Shams

Master Student

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Ahmed H Elkhadem, Ass. professor

Role: STUDY_CHAIR

Cairo University

Central Contacts

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Reem H Shams, B.D.S

Role: CONTACT

01099898731 ext. 002

maii M Ali, Lecturer

Role: CONTACT

01012632608 ext. 022

References

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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.

Reference Type BACKGROUND
PMID: 26719946 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/PMC8600830/

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

Other Identifiers

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457

Identifier Type: -

Identifier Source: org_study_id

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