Clear aligners versus fixed orthodontic appliances in surgery first orthognathic surgery

Surgery first and Invisalign. A comparative assessment of periodontal health and quality of life in postsurgical orthodontic treatment with Invisalign or traditional fixed appliances: a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN11587056

Enrollment

Registered

2020-06-02

Start date

2016-05-01

Completion date

Unknown

Last updated

2023-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentofacial deformity Oral Health

Interventions

Baseline characteristics including periodontal status and quality of life are recorded. All patients in the study receive professional oral hygiene treatment by an experienced dental hygienist. They a

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Measured immediately before surgery, 1 month after surgery and at the end of study: 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) 2. Quality of life assessed using the short version of the Oral Health Impact Profile (OHIP-14)	—

Countries

Spain

Contacts

Public ContactPatricia de Leyva

patricia.leyva@salud.madrid.org+34 (0)913368051

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026