Comparison of Two Miniscrew Anchored Maxillary Protraction Protocols

NCT03712007 | Completed

• 1 other identifier: 67610717.7.0000.5417
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Orthodontic Anchorage Procedures; Malocclusion, Angle Class III; Palatal Expansion Technique.; Cone-Beam Computed Tomography; Dental Models

Outcome Measures

Primary Outcomes (5)

• 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.

  12 months

• 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.

  12 months

• 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.

  12 months

• 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.

  12 months

• 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.

  12 months

Secondary Outcomes (10)

• Maxillary and mandibular inter-first permanent molar distances

  12 months

• Maxillary and mandibular intercanine distances

  12 months

• Maxillary and mandibular dental arches perimeters

  12 months

• Maxillary and mandibular dental arches lengths

  12 months

• Inclination of maxillary and mandibular first permanent molars

  12 months

Study Arms (2)

MAMP therapy with MARPE expander

EXPERIMENTAL

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.

Device: MAMP therapy with MARPE expander

MAMP therapy with Hyrax expander

ACTIVE COMPARATOR

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.

Device: MAMP therapy with Hyrax expander

Interventions

MAMP therapy with MARPE expander DEVICE

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.

MAMP therapy with MARPE expander

MAMP therapy with Hyrax expander DEVICE

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.

MAMP therapy with Hyrax expander

Eligibility Criteria

• Age: 9 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo: lead
• Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

University of São Paulo

Bauru, São Paulo, 17012901, Brazil

Location

Related Publications (2)

• 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.

  PMID: 34509329 DERIVED

• 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.

  PMID: 34041608 DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class III; Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic 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. and PhD Student

Study Record Dates

• First Submitted: October 7, 2018
• First Posted: October 19, 2018
• Study Start: June 9, 2017
• Primary Completion: August 10, 2019
• Study Completion: August 10, 2019
• Last Updated: May 12, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)