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Comparison of Two Miniscrew Anchored Maxillary Protraction Protocols

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ClinicalTrials.gov Identifier: NCT03712007
Recruitment Status : Active, not recruiting
First Posted : October 19, 2018
Last Update Posted : October 19, 2018
Sponsor:
Collaborators:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Felicia Miranda, University of Sao Paulo

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.

Condition or disease Intervention/treatment Phase
Malocclusion, Angle Class III Crossbite (Anterior) (Posterior) Device: MAMP therapy with MARPE expander Device: MAMP therapy with Hyrax expander Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Two Miniscrew Anchored Maxillary Protraction Protocols: a Randomized Clinical Trial
Actual Study Start Date : June 9, 2017
Estimated Primary Completion Date : August 10, 2019
Estimated Study Completion Date : August 10, 2019

Arm Intervention/treatment
Experimental: MAMP therapy with MARPE expander
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
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.

Active Comparator: MAMP therapy with Hyrax expander
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
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 Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   9 Years to 13 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712007


Locations
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Brazil
University of São Paulo
Bauru, São Paulo, Brazil, 17012901
Sponsors and Collaborators
University of Sao Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Fundação de Amparo à Pesquisa do Estado de São Paulo

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Responsible Party: Felicia Miranda, DDS, MSc. and PhD Student, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03712007     History of Changes
Other Study ID Numbers: 67610717.7.0000.5417
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Felicia Miranda, University of Sao Paulo:
Orthodontic Anchorage Procedures
Malocclusion, Angle Class III
Palatal Expansion Technique.
Cone-Beam Computed Tomography
Dental Models

Additional relevant MeSH terms:
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Malocclusion
Malocclusion, Angle Class III
Prognathism
Tooth Diseases
Stomatognathic Diseases
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Mandibular Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities