Clear aligners versus fixed orthodontic appliances in surgery first orthognathic surgery

Not Applicable

Completed

• Conditions: Dentofacial deformity; Oral Health

• Registration Number: ISRCTN11587056
• Lead Sponsor: Instituto Ramón y Cajal de Investigación Sanitaria

Brief Summary

2019 Abstract results in https://doi.org/10.1016/j.ijom.2019.03.582 (added 04/03/2022) 2023 Results article in https://doi.org/10.4317/medoral.25555 (added 19/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-02-02
• Study Start: 2020-06-02
• Last Update Posted: 2 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

1. Skeletal malocclusion requiring combined surgical and orthodontic treatment without extractions
2. Informed consent for this novel protocol

Exclusion Criteria

1. Temporomandibular joint disorders or severe symptoms
2. Uncontrolled periodontal disease
3. Severe crowding requiring extractions
4. Class II division 2 malocclusion with overbite or severely altered curves of Spee
5. Severe asymmetry

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Measured immediately before surgery, 1 month after surgery and at the end of study:<br> 1. Plaque index assessed by visual inspection of the plaque accumulation and recorded according to the modified index of Loe (0-3)<br> 2. Quality of life measured using Orthognathic Quality of Life Questionnaire (OQLQ-22)<br>

Secondary Outcome Measures

Name	Time	Method
<br> Measured immediately before surgery, 1 month after surgery and at the end of study:<br> 1. Probing depth (PD) and bleeding on probing (BP) assessed by periodontal probing on the gingival pocket and recorded in milimetres (PD) and as absent or present (BP)<br> 2. Quality of life assessed using the short version of the Oral Health Impact Profile (OHIP-14)<br>