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NCT Number: NCT05822271

Evaluation of Surgical Outcomes of Patients Treated With the Surgery First Approach and Aligners

The purpose of this prospective study is to compare treatment outcomes and the quality of life of skeletal Class III patients treated with conventional fixed appliances and aligners undergoing Surgery-first approach. Data will be collected through validated questionnaires: OQLQ (Orthognathic Quality of Life Questionnaire), OHIP-14 (Oral Health Impact Profile), SF-36 (Medical Outcomes Study 36 - Item Short-Form Health Survey) and IOTN (Index of Orthodontic Treatment Need).

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Key information

Conditions

Malocclusion, Angle Class III Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

17 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rio de Janeiro State University

Rio de Janeiro, 20551-030, Brazil

Location status: Recruiting

Location contact

Arthur Cunha, MSc

CONTACT

[email protected]

+5521967637007

Arthur Cunha, MSc

PRINCIPAL_INVESTIGATOR

Jose Augusto M Miguel, PhD

CONTACT

[email protected]

+5521972821500

Jose Augusto M Miguel, PhD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults;
  • Skeletal malocclusion;
  • ANB Angle zero or negative;
  • Witts negative;
  • Etiology: mandibular excess, a maxillary deficiency, or a combination of both;
  • Indication for bimaxillary surgery;

Exclusion criteria

  • Previous orthodontic treatment;
  • Craniofacial anomaly or previous fracture of the facial bones;
  • Total edentulism;
  • Deep curve of Spee;
  • Vertical asymmetry;
  • Any medication use that contraindicates surgical treatment.

Treatment and study plan

Orthognathic Surgery

Procedure

Type of surgery performed to correct skeletal malocclusions

Primary outcomes

  1. Quality of life accessed by validated questionnaires.

    Time frame: at the end of orthodontic treatment (up to 2 years).

    Comparison between quality of life changes in the two groups at the end of treatment.

Secondary outcomes

  1. Periodontal status.

    Time frame: at the end of orthodontic treatment (up to 2 years).

    Comparison between periodontal changes in the two groups at the end of the treatment.

  2. Treatment duration.

    Time frame: at the end of orthodontic treatment (up to 2 years).

    Comparison between treatment time in the two groups at the end of the treatment.

  3. Facial changes as measured by tomographic superimposition of the face.

    Time frame: at the end of orthodontic treatment (up to 2 years).

    Comparison between facial changes in the two groups at the end of the treatment.

  4. Incisors inclination

    Time frame: at the end of orthodontic treatment (up to 2 years).

    Quantitative assessment of incisors inclination between the two groups as measured by tomographic superimposition at the end of orthodontic treatment.

  5. Alveolar bone changes around incisors.

    Time frame: at the end of orthodontic treatment (up to 2 years).

    Comparison between the alveolar bone changes around incisors by tomographic.

  6. Swelling as measured by tomographic images.

    Time frame: 12 months post-operative.

    Comparison between facial swelling in the two groups after orthognathic surgery.

  7. Surgery stability as measured by tomographic superimposition.

    Time frame: 12 months post-operative.

    Comparison between surgery stability in the two groups at the end of the treatment.

  8. Changes in relationship between maxilla and mandible as measured by tomographic superimposition of the cranial base.

    Time frame: 12 months post-operative.

    Comparison between the changes of the relationship among maxilla and mandible in the two groups at the end of the treatment.

Study contacts

Contact information is provided by the study sponsor or research team.

Arthur Cunha, MSc

CONTACT

[email protected]

55-21-967637007

Jose Augusto M Miguel, PhD

CONTACT

[email protected]

55-21-972821500

Sponsors and collaborators

Lead sponsor

Rio de Janeiro State University

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 20, 2023
Registry last updated
Dec 2, 2024

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.

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