3D evaluation of postoperative swelling in treatment of zygomatic bone fractures using 2 different cooling therapy methods: - A randomized observer blind prospective study –

3D evaluation of postoperative swelling in treatment of zygomatic bone fractures using 2 different cooling therapy methods: - A randomized observer blind prospective study – - Cooling therapy in treatment of zygomatic fractures

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004846

Enrollment

Registered

2013-03-26

Start date

2009-01-12

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

S02.4

Interventions

Group 1: 21 patients were treated with conventional cooling after reposition of unilateral zygomatic bone fractures Group 2: 21 patients received continuous cooling using hilotherapy after reposition

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: unilateral zygomatic bone fracture

Exclusion criteria

Exclusion criteria: missing operability, foreseeable missing opportunity for follow-up examination, pregnancy, nursing, drug addiction, recent operations, and diseases of heart, metabolism, CNS, infectious, circulation, systemic, malignant and immune system affecting diseases as well as blood coagulation disorders and allergic reactions to pharmaceuticals and antibiotics

Design outcomes

Primary

Measure	Time frame
swelling: 3D optical scans were recorded at 6 points in time: on the 1st day after surgery (T1), on the 2nd (T2), the 3rd (T3), the 7th (T4) and the 28th (T5) and the 90th (T6) postoperative day pain: 10-point visual analogue scale (VAS) based on measurements before surgery (T0), on the 1st (T1), 2nd (T2) and 7th (T3) day after operation eye motility and diplopia: For the analysis of eye motility and diplopia the patient was required to fix a light source at a distance of 30 cm. While the head was fixed, the light source was guided in different directions of view. The relative displacement of the reflected images to each other and the movement of the eye were analyzed. Meanwhile, the patient was asked about diplopia. The data were collected at 4 points in time: before surgery (T0), on the 1st (T1), the 7th (T2) and the 28th (T3) postoperative day. neurological complaints: The skin of the upper lip was checked using a cotton test for touch sensation, a pinprick test using a needle for sharp pain and a blunt instrument for testing pressure. Additionally, a two-point discrimination test was executed on the lip. The results were recorded on a score that ranges between 0 and 9, with 9 being the worst neurological score. The neurological score was assessed at 5 points in time: before surgery (T0), on the 1st (T1), the 7nd (T2), the 28th (T3), and the 90th (T4) postoperative day patient satisfaction:Each patient was asked to complete a questionnaire on the 10th postoperative day subjectively rating their comfort and satisfaction with the applied postoperative cooling therapy. The grading scale ranged from 1 to 4, where 1 denoted “very satisfied” and 4 for “not satisfied”.	—

Measure

Time frame

swelling: 3D optical scans were recorded at 6 points in time: on the 1st day after surgery (T1), on the 2nd (T2), the 3rd (T3), the 7th (T4) and the 28th (T5) and the 90th (T6) postoperative day pain: 10-point visual analogue scale (VAS) based on measurements before surgery (T0), on the 1st (T1), 2nd (T2) and 7th (T3) day after operation eye motility and diplopia: For the analysis of eye motility and diplopia the patient was required to fix a light source at a distance of 30 cm. While the head was fixed, the light source was guided in different directions of view. The relative displacement of the reflected images to each other and the movement of the eye were analyzed. Meanwhile, the patient was asked about diplopia. The data were collected at 4 points in time: before surgery (T0), on the 1st (T1), the 7th (T2) and the 28th (T3) postoperative day. neurological complaints: The skin of the upper lip was checked using a cotton test for touch sensation, a pinprick test using a needle for sharp pain and a blunt instrument for testing pressure. Additionally, a two-point discrimination test was executed on the lip. The results were recorded on a score that ranges between 0 and 9, with 9 being the worst neurological score. The neurological score was assessed at 5 points in time: before surgery (T0), on the 1st (T1), the 7nd (T2), the 28th (T3), and the 90th (T4) postoperative day patient satisfaction:Each patient was asked to complete a questionnaire on the 10th postoperative day subjectively rating their comfort and satisfaction with the applied postoperative cooling therapy. The grading scale ranged from 1 to 4, where 1 denoted “very satisfied” and 4 for “not satisfied”.

—

Countries

Germany

Contacts

Public ContactMajeed Rana

Medizinische Hochschule Hannover Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie

rana.majeed@mh-hannover.de+49-511-532-4716

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 23, 2026