Skip to main content
OpenTrials
Completed

NCT Number: NCT03712007

Comparison of Two Miniscrew Anchored Maxillary Protraction Protocols

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malocclusion, Angle Class III Crossbite (Anterior) (Posterior) Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

9 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of São Paulo

Bauru, São Paulo, 17012901, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 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.

Primary outcomes

  1. Maxillary sagittal skeletal discrepancy

    Time frame: 12 months

    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.

  2. Mandibular sagittal skeletal discrepancy

    Time frame: 12 months

    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.

  3. Vertical skeletal discrepancy

    Time frame: 12 months

    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.

  4. Teeth discrepancy

    Time frame: 12 months

    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.

  5. Soft tissue discrepancy

    Time frame: 12 months

    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 outcomes

  1. Maxillary and mandibular inter-first permanent molar distances

    Time frame: 12 months

    Arch dimensions will be measured in digital dental models obtained before (T1) and after treatment (T2).

  2. Maxillary and mandibular intercanine distances

    Time frame: 12 months

    The intercanine distance will be measured in digital dental models obtained before (T1) and after treatment (T2).

  3. Maxillary and mandibular dental arches perimeters

    Time frame: 12 months

    Arch perimeter will be measured in digital dental models obtained before (T1) and after treatment (T2).

  4. Maxillary and mandibular dental arches lengths

    Time frame: 12 months

    Arch lenght will be measured in digital dental models obtained before (T1) and after treatment (T2).

  5. Inclination of maxillary and mandibular first permanent molars

    Time frame: 12 months

    Teeth inclination will be measured in digital dental models obtained before (T1) and after treatment (T2).

  6. Amount of interincisor diastema

    Time frame: 7 days

    The interincisor diastema will be measured in the occlusal radiograph and partial model obtained immediately after expansion.

  7. Three-dimensional changes

    Time frame: 12 months

    Three-dimensional changes will be observed by the cranial base superimposition of the CBCT exams obtained before (T1) and after treatment (T2).

  8. Discomfort and pain

    Time frame: 1 month

    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.

  9. Parents perception of pain

    Time frame: 1 month

    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.

  10. Quality of life evaluation

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Collaborators

  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Registry information

Official study title

Comparison of Two Miniscrew Anchored Maxillary Protraction Protocols: a Randomized Clinical Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 19, 2018
Registry last updated
May 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.