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OpenTrials
Completed

NCT Number: NCT07431268

Dietary Interventions to Reduce Postoperative Weight Loss and Improve Recovery After Orthognathic Surgery

Objectives This randomized controlled trial aimed to assess whether structured dietary interventions, implemented both before and after orthognathic surgery, could minimize postoperative weight loss and thereby enhance recovery during the first eight weeks.

Material and Methods The study was conducted at Aalborg University Hospital, Denmark, from April 2017 to April 2022, involving patients undergoing single- or bimaxillary surgery. Participants were randomly allocated into two intervention groups receiving nutritional supplements and one control group. Body composition was assessed using a Body Composition Analyzer at five time points: pre-surgery examination, admission, and follow-ups weeks 1, 3, and 8. Primary outcome was weight, secondary outcomes included BMI, fat mass, fat-free mass, total body water, and visceral fat rating. Additional data were collected on age, gender, type of surgery, and hospitalization duration.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University Hospital

Aalborg, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients of both sexes with dentofacial deformities who underwent single- or bimaxillary surgery (Le Fort I osteotomy and/or bilateral sagittal split osteotomy) were included in the study.

Exclusion criteria

Patients not willing to complete the planned treatment in the intervention groups.

Treatment and study plan

Intervention group receiving nutritional supplements through G-tube and Protein drinks

Other

Nutrition supplement: G-tube administered Nutrition and Protein drinks

Intervention group receiving nutritional supplements through Protein drinks

Other

Nutrition supplements recieved through intake of Protein drinks

Primary outcomes

  1. Change from baseline in weight in kilogram after orthognatic surgery

    Time frame: From enrollment, (14 days before surgery), to 8 weeks after surgery.

    Weight changes was the primary measure of interest, assessed using the Tanita BC-418 Segmental Body Composition Analyzer.

    Measurements were taken during scheduled hospital appointments; the pre-surgery examination, admission interview, and follow-up visits at week 1-, 3- and 8.

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Registry information

Official study title

Systematic Dietary Interventions to Minimize Postoperative Weight Loss and Enhance Recovery Following Orthognathic Surgery

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

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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