Orthognathic SurgeryNCT07431268
Dietary Interventions to Reduce Postoperative Weight Loss and Improve Recovery After Orthognathic Surgery
A study testing Intervention group receiving nutritional supplements through G-tube and Protein drinks and Intervention group receiving nutritional supplements through Protein drinks in people with Orthognathic Surgery, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Orthognathic Surgery
- What is being tested?
- Intervention group receiving nutritional supplements through G-tube and Protein drinks and Intervention group receiving nutritional supplements through Protein drinks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Apr 2017to 11 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systematic Dietary Interventions to Minimize Postoperative Weight Loss and Enhance Recovery Following 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.
- Conditions
- Orthognathic Surgery
- Being tested
- Intervention group receiving nutritional supplements through G-tube and Protein drinks, Intervention group receiving nutritional supplements through Protein drinks
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group receiving nutritional supplements through G-tube and Protein drinksOther
Nutrition supplement: G-tube administered Nutrition and Protein drinks
Intervention group receiving nutritional supplements through Protein drinksOther
Nutrition supplements recieved through intake of Protein drinks
| Study group | Role | What they receive |
|---|---|---|
| Controle | No intervention | Usual care |
| G-tube administered Nutrition and Protein drinks | Experimental | Nutrition supplement: G-tube administered Nutrition and Protein drinks Receives: Other: Intervention group receiving nutritional supplements through G-tube and Protein drinks |
| Protein drink | Experimental | Nutrition supplement: Protein drink Receives: Other: Intervention group receiving nutritional supplements through Protein drinks |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment, (14 days before surgery), to 8 weeks after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start18 Apr 2017
- Primary completion11 Apr 2022
- Study completion11 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthognathic SurgeryStudies of the same condition, open and under way.
- More trials run by Aalborg University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Germund Nielsen, Aalborg University Hospital
- Investigators
- Karin Bundgaard, PhD, Principal investigator, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431268
- Sponsor's protocol ID
- 2016-130
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Dietary Interventions to Minimize Postoperative Weight Loss and Enhance Recovery Following Orthognathic Surgery
- ClinicalTrials.gov ID
- NCT07431268
- Acronym / sponsor ID
- 2016-130
- Conditions
- Orthognathic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 18 Apr 2017 (actual)
- Primary completion
- 11 Apr 2022 (actual)
- Study completion
- 11 Apr 2022 (actual)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Controle | No intervention | –Usual care |
| G-tube administered Nutrition and Protein drinks | Experimental | Other: Intervention group receiving nutritional supplements through G-tube and Protein drinksNutrition supplement: G-tube administered Nutrition and Protein drinks |
| Protein drink | Experimental | Other: Intervention group receiving nutritional supplements through Protein drinksNutrition supplement: Protein drink |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention group receiving nutritional supplements through G-tube and Protein drinksNutrition supplement: G-tube administered Nutrition and Protein drinks | Other | G-tube administered Nutrition and Protein drinks |
| Intervention group receiving nutritional supplements through Protein drinksNutrition supplements recieved through intake of Protein drinks | Other | Protein drink |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karin Bundgaard, PhD principal investigator
Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group receiving nutritional supplements through G-tube and Protein drinks and Intervention group receiving nutritional supplements through Protein drinks in people with Orthognathic Surgery, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in weight in kilogram after orthognatic surgery (time frame: From enrollment, (14 days before surgery), to 8 weeks after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.