NCT05313399

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2022

Shorter than P25 for phase_3

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2022

Completed
10 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 6, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

April 6, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

March 22, 2022

Last Update Submit

April 1, 2022

Conditions

Anterior Open Bite

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Changes in maxillary mandibular plane angle

    12 months

  • Patient acceptance

    1 month

Study Arms (2)

control group

ACTIVE COMPARATOR

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

Device: Palatal Crib

experimental group

EXPERIMENTAL

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

Device: bonded spur

Interventions

Palatal CribDEVICE

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.

control group
bonded spurDEVICE

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

experimental group

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • Children with loss of permanent teeth.
  • Crowding, maxillary constriction, or posterior crossbites.
  • Previous orthodontic treatment.
  • Presence of craniofacial anomalies or syndromes.
  • Tooth agenesis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 26719946BACKGROUND

Related Links

Study Officials

  • Ahmed H Elkhadem, Ass. professor

    Cairo University

    STUDY CHAIR

Central Study Contacts

Reem H Shams, B.D.S

CONTACT

01099898731reem.shamseldin@dentistry.cu.edu.eg

maii M Ali, Lecturer

CONTACT

01012632608maii.ali@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Master Student

Study Record Dates

First Submitted

March 22, 2022

First Posted

April 6, 2022

Study Start

April 1, 2022

Primary Completion

April 1, 2023

Study Completion

May 1, 2023

Last Updated

April 6, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share