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

NCT07431268 | Completed

• 1 other identifier: 2016-130
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Orthognathic Surgery

Outcome Measures

Primary Outcomes (1)

• Change from baseline in weight in kilogram after orthognatic 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.

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

Study Arms (3)

Controle

NO INTERVENTION

Usual care

G-tube administered Nutrition and Protein drinks

EXPERIMENTAL

Nutrition supplement: G-tube administered Nutrition and Protein drinks

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

Protein drink

EXPERIMENTAL

Nutrition supplement: Protein drink

Other: Intervention group receiving nutritional supplements through Protein drinks

Interventions

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

Nutrition supplement: G-tube administered Nutrition and Protein drinks

G-tube administered Nutrition and Protein drinks

Intervention group receiving nutritional supplements through Protein drinks OTHER

Nutrition supplements recieved through intake of Protein drinks

Protein drink

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Aalborg University Hospital

Aalborg, Denmark

Location

Study Officials

• Karin Bundgaard, PhD

  Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 24, 2026
• Study Start: April 18, 2017
• Primary Completion: April 11, 2022
• Study Completion: April 11, 2022
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)