NCT03702881

Brief Summary

This study compares the dentoalveolar and skeletal effects of bonded spurs associated with build-ups versus conventional bonded spurs in the early treatment of anterior open bite patients. Half of participants will be treated with bonded spurs associated with build-ups, while the other half will be treated with conventional bonded spurs. The null hypothesis to be tested is that there are no differences for the dentoalveolar and skeletal effects between the two protocols.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 9, 2017

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 11, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2020

Completed
Last Updated

May 12, 2021

Status Verified

May 1, 2021

Enrollment Period

1.8 years

First QC Date

October 7, 2018

Last Update Submit

May 11, 2021

Conditions

MalocclusionOpen Bite

Keywords

Open BiteOrthodontic applianceCephalometryDental models

Outcome Measures

Primary Outcomes (4)

  • Overbite (mm)

    12 months

  • Gonial angle (º)

    12 months

  • Mandibular plane angle (º)

    12 months

  • Maxillary and mandibular molar vertical development (mm)

    12 months

Secondary Outcomes (62)

  • Overbite (mm)

    24 months

  • Gonial angle (º)

    24 months

  • Mandibular plane angle (º)

    24 months

  • Maxillary and mandibular molar vertical development (mm)

    24 months

  • Maxillary and mandibular position (º)

    12 months

  • +57 more secondary outcomes

Study Arms (2)

Bonded Spurs associated with posterior build-ups Group

EXPERIMENTAL

The experimental group will consist of 25 patients treated with bonded spurs associated with build-ups.

Device: Bonded Spurs associated with posterior build-ups

Conventional bonded spurs Group

ACTIVE COMPARATOR

Active comparator group will consist of 25 patients treated with conventional bonded spurs

Device: Conventional bonded spurs

Interventions

Bonded Spurs associated with posterior build-upsDEVICE

Twenty-five patients will be treated with bonded spurs associated with posterior build-ups. The cervical portion of the palatal surfaces of the maxillary incisors and the incisal portion of the lingual surfaces of the mandibular incisors will be pumiced, rinsed, dried, and acid etched with 37% phosphoric acid. The etched surfaces will be subsequently rinsed and carefully dried. Then, the spurs will be bonded using Transbond primer/adhesive. The positions for the spurs will be chose to prevent possible future occlusal interferences The spurs will be sharpened with a carborundum disk before bonding. In addition, posterior build-ups (resin blocks) will be cemented on the functional cusps of all maxillary posterior teeth. The treatment time will be 12 months. After this time, the posterior build ups will be removed and the bonded spurs will be maintained for 12 months more, as active retention.

Bonded Spurs associated with posterior build-ups Group
Conventional bonded spursDEVICE

Twenty-five patients will be treated only with bonded spurs. The bonding of the spurs will follow the same protocol described for the experimental group. The treatment time will be 12 months. After this time, the bonded spurs will be maintained for 12 months more, as active retention.

Conventional bonded spurs Group

Eligibility Criteria

Age7 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients between 7 to 11 years old,
  • erupted permanent first permanent molars,
  • anterior open bite (AOB) greater than 1 mm,
  • maxillary and mandibular permanent central incisors fully erupted,
  • no or mild crowding,
  • without the need of maxillary expansion
  • Children in the first transitional period will be considered to be eligible for treatment when the maxillary lateral incisors are beginning to erupt and the maxillary central incisors still show an open bite

You may not qualify if:

  • previous orthodontic treatment,
  • craniofacial anomalies or syndromes,
  • tooth agenesis,
  • loss of permanent teeth,
  • severe crowding,
  • maxillary constriction or posterior crossbite

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bauru Dental School, University of São Paulo

Bauru, São Paulo, 17012901, Brazil

Location

Related Publications (4)

  • Aliaga-Del Castillo A, Maranon-Vasquez GA, Janson G, Vilanova L, Miranda F, Massaro C, Bellini-Pereira SA, Arriola-Guillen LE, Yatabe M, Ruellas AC, Cevidanes L, Garib D. Oral health-related quality of life, adaptation/discomfort during open bite treatment with spurs: complementary analysis from a randomized clinical trial. Sci Rep. 2024 Mar 8;14(1):5732. doi: 10.1038/s41598-024-56363-0.

    PMID: 38459254DERIVED

  • Aliaga-Del Castillo A, Janson G, Vilanova L, Cevidanes L, Yatabe M, Garib D, Arriola-Guillen LE, Miranda F, Massaro C, Bellini-Pereira SA, Ruellas AC. Three-dimensional dentoalveolar changes in open bite treatment in mixed dentition, spurs/posterior build-ups versus spurs alone: 1-year follow-up randomized clinical trial. Sci Rep. 2022 Jul 20;12(1):12378. doi: 10.1038/s41598-022-15988-9.

    PMID: 35858941DERIVED

  • Aliaga-Del Castillo A, Bellini-Pereira SA, Vilanova L, Miranda F, Massaro C, Arriola-Guillen LE, Garib D, Janson G. Dental arch changes after open bite treatment with spurs associated with posterior build-ups in the mixed dentition: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2021 Jun;159(6):714-723.e1. doi: 10.1016/j.ajodo.2020.11.036. Epub 2021 Mar 30.

    PMID: 33795189DERIVED

  • Aliaga-Del Castillo A, Vilanova L, Miranda F, Arriola-Guillen LE, Garib D, Janson G. Dentoskeletal changes in open bite treatment using spurs and posterior build-ups: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2021 Jan;159(1):10-20. doi: 10.1016/j.ajodo.2020.06.031. Epub 2020 Nov 18.

    PMID: 33221096DERIVED

MeSH Terms

Conditions

MalocclusionOpen Bite

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS, MSc., PhD Student

Study Record Dates

First Submitted

October 7, 2018

First Posted

October 11, 2018

Study Start

June 9, 2017

Primary Completion

April 15, 2019

Study Completion

April 15, 2020

Last Updated

May 12, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)