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Comparison of Two Miniscrew Anchored Maxillary Protraction Protocols

Primary Purpose

Malocclusion, Angle Class III, Crossbite (Anterior) (Posterior)

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
MAMP therapy with MARPE expander
MAMP therapy with Hyrax expander
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malocclusion, Angle Class III focused on measuring Orthodontic Anchorage Procedures, Malocclusion, Angle Class III, Palatal Expansion Technique., Cone-Beam Computed Tomography, Dental Models

Eligibility Criteria

9 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Both sexes;
  • Ages ranging from 9 to 13 years old;
  • Class III malocclusion;
  • Mandibular canines erupted.

Exclusion Criteria:

  • Previous orthodontic treatment;
  • Cleft lip and palate;
  • Craniofacial syndromes;
  • Systemic and/or neurological diseases.

Sites / Locations

  • University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MAMP therapy with MARPE expander

MAMP therapy with Hyrax expander

Arm Description

The experimental group will comprise 20 patients submitted to miniscrew anchored maxillary protraction (MAMP) with a tooth-bone-borne expander as anchorage in the maxillary arch. The miniscrew assisted rapid palatal expander (MARPE) will be used.

The active comparator group will comprise 15 patients submitted to miniscrew anchored maxillary protraction (MAMP) with a tooth-borne expander as anchorage in the maxillary arch. The conventional hyrax expander will be used.

Outcomes

Primary Outcome Measures

Maxillary sagittal skeletal discrepancy
CBCT exams will be obtained before (T1) and after treatment (T2). Reformatted lateral cephalometric images will be obtained using Dolphin software for comparisons with conventional cephalograms. The maxillary sagittal skeletal discrepancy will be observed using the variables: SNA, Co-A, Condylion to ANS and others.
Mandibular sagittal skeletal discrepancy
CBCT exams will be obtained before (T1) and after treatment (T2). Reformatted lateral cephalometric images will be obtained using Dolphin software for comparisons with conventional cephalograms. Mandibular sagittal skeletal discrepancy will be observed using the variables: Co-Gn, SNB, Gonial/Jaw Angle and others.
Vertical skeletal discrepancy
CBCT exams will be obtained before (T1) and after treatment (T2). Reformatted lateral cephalometric images will be obtained using Dolphin software for comparisons with conventional cephalograms. Vertical skeletal discrepancy will be observed using the variables: Occ Plane to SN, NF - FH (PP-FH), SN - GoGn, SN- Palatal Plane and others.
Teeth discrepancy
CBCT exams will be obtained before (T1) and after treatment (T2). Reformatted lateral cephalometric images will be obtained using Dolphin software for comparisons with conventional cephalograms. Teeth discrepancy will be observed using the variables: Overjet, Overbite, Interincisal Angle (U1-L1), Molar Relation, Mesial Molar Relationship, U1 - Palatal Plane, IMPA and others.
Soft tissue discrepancy
CBCT exams will be obtained before (T1) and after treatment (T2). Reformatted lateral cephalometric images will be obtained using Dolphin software for comparisons with conventional cephalograms. Soft tissue discrepancy will be observed using the variables: Nasolabial Angle (Col-Sn-UL), Upper Lip to E-Plane, Lower Lip to E-Plane, Upper Lip - S line, Lower Lip - S line and others.

Secondary Outcome Measures

Maxillary and mandibular inter-first permanent molar distances
Arch dimensions will be measured in digital dental models obtained before (T1) and after treatment (T2).
Maxillary and mandibular intercanine distances
The intercanine distance will be measured in digital dental models obtained before (T1) and after treatment (T2).
Maxillary and mandibular dental arches perimeters
Arch perimeter will be measured in digital dental models obtained before (T1) and after treatment (T2).
Maxillary and mandibular dental arches lengths
Arch lenght will be measured in digital dental models obtained before (T1) and after treatment (T2).
Inclination of maxillary and mandibular first permanent molars
Teeth inclination will be measured in digital dental models obtained before (T1) and after treatment (T2).
Amount of interincisor diastema
The interincisor diastema will be measured in the occlusal radiograph and partial model obtained immediately after expansion.
Three-dimensional changes
Three-dimensional changes will be observed by the cranial base superimposition of the CBCT exams obtained before (T1) and after treatment (T2).
Discomfort and pain
Discomfort and pain will be evaluated using a visual analog scale of 10-cm, where 0-cm is no discomfort/pain and 10-cm is the greatest discomfort/pain.
Parents perception of pain
Parents perception of pain will be evaluated using a visual analog scale of 10-cm, where 0-cm is no discomfort/pain and 10-cm is the greatest discomfort/pain.
Quality of life evaluation
CPQ (Child Perceptions Questionnaires) will be used to evaluated quality of life. The CPQ8-10 and CPQ11-14 will be applied before (T1), during and after (T2) treatment for patients of both groups.

Full Information

First Posted
October 7, 2018
Last Updated
May 11, 2021
Sponsor
University of Sao Paulo
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do Estado de São Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT03712007
Brief Title
Comparison of Two Miniscrew Anchored Maxillary Protraction Protocols
Official Title
Comparison of Two Miniscrew Anchored Maxillary Protraction Protocols: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
June 9, 2017 (Actual)
Primary Completion Date
August 10, 2019 (Actual)
Study Completion Date
August 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Fundação de Amparo à Pesquisa do Estado de São Paulo

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study evaluates the dentoskeletal effects produced by two maxillary protraction protocols in adolescent patients. Half of participants will be treated with a tooth-borne and tooth-bone-borne expanders as anchorage in the maxillary arch. Miniscrews will be used as anchorage in the mandibular arch for both groups.
Detailed Description
Class III malocclusion treatment in growing patients is challenging. A new treatment for maxillary protraction using skeletal anchorage reported an efficient maxillary protraction in the late mixed dentition an early permanent dentition. Therefore, the aim of this study is to compare the dentoskeletal effects produced by two maxillary protraction protocols anchored on miniscrews. The sample will be recruited at the Orthodontic Clinic of Bauru Dental School, University of São Paulo, Brazil. A sample of thirty-five patients, between 9 and 13 years old will be selected. The inclusion criteria are: Class III malocclusion associated with anterior crossbite. The participants will be allocated into 2 groups. Group 1 will comprise 20 individuals treated with a tooth-bone-borne expander and 2 miniscrews in the mandible Group 2 will comprise 15 individuals treated with a tooth-borne expander and 2 miniscrews in the mandible. Digital models and cone-beam computed tomography (CBCT) will be obtained before (T1) and 12 months after treatment (T2). Occlusal radiographs and partial (canine to canine) models will be obtained before and immediately after expansion. Two-dimensional cephalometric evaluations will be performed in the Dolphin® software. The arch width, arch perimeter and arch length will be analyzed with the Orthoanalyzer® software. Three-dimensional superimposition at the cranial base of T1 and T2 CBCT images will be performed. The inter incisor diastema will be evaluated by occlusal radiographs and dental models. Discomfort, pain and quality of life will evaluated by questionnaires. After verifying the normal distribution, the intragroup comparison will be performed with paired t test and intergroup comparison will be performed with t test. In the case of lost to follow-up patients, intention to treat analysis will be used. A significance level of 5% will be regarded for all tests. Temporary pain and discomfort are possible after the installation of the miniscrews. Patients and legal guardians will be informed. After the consent, the treatment can be stoped at any time.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Angle Class III, Crossbite (Anterior) (Posterior)
Keywords
Orthodontic Anchorage Procedures, Malocclusion, Angle Class III, Palatal Expansion Technique., Cone-Beam Computed Tomography, Dental Models

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MAMP therapy with MARPE expander
Arm Type
Experimental
Arm Description
The experimental group will comprise 20 patients submitted to miniscrew anchored maxillary protraction (MAMP) with a tooth-bone-borne expander as anchorage in the maxillary arch. The miniscrew assisted rapid palatal expander (MARPE) will be used.
Arm Title
MAMP therapy with Hyrax expander
Arm Type
Active Comparator
Arm Description
The active comparator group will comprise 15 patients submitted to miniscrew anchored maxillary protraction (MAMP) with a tooth-borne expander as anchorage in the maxillary arch. The conventional hyrax expander will be used.
Intervention Type
Device
Intervention Name(s)
MAMP therapy with MARPE expander
Intervention Description
Twenty patients will be submitted to MAMP therapy with MARPE expander as anchorage in the maxillary arch. The appliance anchorage will be provided by bands adapted on the maxillary first permanent molars and circumferential clamps in the maxillary canines or premolars. The maxillary and mandibular miniscrews will be placed in the same section. After a 24-hour period, parents will be oriented to activate the expander screw. Patients will be instructed to wear intermaxillary elastics connecting the maxillary first molar hooks to the mandibular mini-implants.
Intervention Type
Device
Intervention Name(s)
MAMP therapy with Hyrax expander
Intervention Description
Fifteen patients will be submitted to MAMP therapy with Hyrax expander as anchorage in the maxillary arch. The appliance anchorage will be provided by bands adapted on the maxillary first permanent molars and circumferential clamps in the maxillary canines or premolars. The mandibular miniscrews will be placed and after a 24-hour period, parents will be oriented to activate the expander screw. Patients will be instructed to wear intermaxillary elastics connecting the maxillary first molar hooks and the mandibular mini-implants.
Primary Outcome Measure Information:
Title
Maxillary sagittal skeletal discrepancy
Description
CBCT exams will be obtained before (T1) and after treatment (T2). Reformatted lateral cephalometric images will be obtained using Dolphin software for comparisons with conventional cephalograms. The maxillary sagittal skeletal discrepancy will be observed using the variables: SNA, Co-A, Condylion to ANS and others.
Time Frame
12 months
Title
Mandibular sagittal skeletal discrepancy
Description
CBCT exams will be obtained before (T1) and after treatment (T2). Reformatted lateral cephalometric images will be obtained using Dolphin software for comparisons with conventional cephalograms. Mandibular sagittal skeletal discrepancy will be observed using the variables: Co-Gn, SNB, Gonial/Jaw Angle and others.
Time Frame
12 months
Title
Vertical skeletal discrepancy
Description
CBCT exams will be obtained before (T1) and after treatment (T2). Reformatted lateral cephalometric images will be obtained using Dolphin software for comparisons with conventional cephalograms. Vertical skeletal discrepancy will be observed using the variables: Occ Plane to SN, NF - FH (PP-FH), SN - GoGn, SN- Palatal Plane and others.
Time Frame
12 months
Title
Teeth discrepancy
Description
CBCT exams will be obtained before (T1) and after treatment (T2). Reformatted lateral cephalometric images will be obtained using Dolphin software for comparisons with conventional cephalograms. Teeth discrepancy will be observed using the variables: Overjet, Overbite, Interincisal Angle (U1-L1), Molar Relation, Mesial Molar Relationship, U1 - Palatal Plane, IMPA and others.
Time Frame
12 months
Title
Soft tissue discrepancy
Description
CBCT exams will be obtained before (T1) and after treatment (T2). Reformatted lateral cephalometric images will be obtained using Dolphin software for comparisons with conventional cephalograms. Soft tissue discrepancy will be observed using the variables: Nasolabial Angle (Col-Sn-UL), Upper Lip to E-Plane, Lower Lip to E-Plane, Upper Lip - S line, Lower Lip - S line and others.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Maxillary and mandibular inter-first permanent molar distances
Description
Arch dimensions will be measured in digital dental models obtained before (T1) and after treatment (T2).
Time Frame
12 months
Title
Maxillary and mandibular intercanine distances
Description
The intercanine distance will be measured in digital dental models obtained before (T1) and after treatment (T2).
Time Frame
12 months
Title
Maxillary and mandibular dental arches perimeters
Description
Arch perimeter will be measured in digital dental models obtained before (T1) and after treatment (T2).
Time Frame
12 months
Title
Maxillary and mandibular dental arches lengths
Description
Arch lenght will be measured in digital dental models obtained before (T1) and after treatment (T2).
Time Frame
12 months
Title
Inclination of maxillary and mandibular first permanent molars
Description
Teeth inclination will be measured in digital dental models obtained before (T1) and after treatment (T2).
Time Frame
12 months
Title
Amount of interincisor diastema
Description
The interincisor diastema will be measured in the occlusal radiograph and partial model obtained immediately after expansion.
Time Frame
7 days
Title
Three-dimensional changes
Description
Three-dimensional changes will be observed by the cranial base superimposition of the CBCT exams obtained before (T1) and after treatment (T2).
Time Frame
12 months
Title
Discomfort and pain
Description
Discomfort and pain will be evaluated using a visual analog scale of 10-cm, where 0-cm is no discomfort/pain and 10-cm is the greatest discomfort/pain.
Time Frame
1 month
Title
Parents perception of pain
Description
Parents perception of pain will be evaluated using a visual analog scale of 10-cm, where 0-cm is no discomfort/pain and 10-cm is the greatest discomfort/pain.
Time Frame
1 month
Title
Quality of life evaluation
Description
CPQ (Child Perceptions Questionnaires) will be used to evaluated quality of life. The CPQ8-10 and CPQ11-14 will be applied before (T1), during and after (T2) treatment for patients of both groups.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Both sexes; Ages ranging from 9 to 13 years old; Class III malocclusion; Mandibular canines erupted. Exclusion Criteria: Previous orthodontic treatment; Cleft lip and palate; Craniofacial syndromes; Systemic and/or neurological diseases.
Facility Information:
Facility Name
University of São Paulo
City
Bauru
State/Province
São Paulo
ZIP/Postal Code
17012901
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34509329
Citation
Miranda F, Cunha Bastos JCD, Magno Dos Santos A, Janson G, Pereira Lauris JR, Garib D. Dentoskeletal comparison of miniscrew-anchored maxillary protraction with hybrid and conventional hyrax expanders: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2021 Dec;160(6):774-783. doi: 10.1016/j.ajodo.2021.02.017. Epub 2021 Sep 9.
Results Reference
derived
PubMed Identifier
34041608
Citation
Miranda F, Garib D, Pugliese F, da Cunha Bastos JC, Janson G, Palomo JM. Upper airway changes in Class III patients using miniscrew-anchored maxillary protraction with hybrid and hyrax expanders: a randomized controlled trial. Clin Oral Investig. 2022 Jan;26(1):183-195. doi: 10.1007/s00784-021-03989-3. Epub 2021 May 27.
Results Reference
derived

Learn more about this trial

Comparison of Two Miniscrew Anchored Maxillary Protraction Protocols

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