Maxillofacial Abnormalities Clinical Trial
— DLMOFOfficial title:
Impact of Manual Lymphatic Drainage on Postoperative Edema of the Face and the Neck After Orthognathic Surgery.Open-label Multicenter Randomized Controlled Trial
Verified date | October 2018 |
Source | University Hospital, Tours |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Orthognathic surgery aims to standardize position of the maxilla and the mandible and
therefore chewing, breathing, phonation and swallowing functions. In postoperative, several
physical and functional consequences are observed in patients: transient edema of the face,
maxillo-mandibular blocking (causing difficulties to eat and occasional weight loss), pain
and sensory disturbances (labial or/and chin paresthesias).
Achieving sessions of manual lymphatic drainage by physiotherapist may allow faster decrease
of postoperative edema, improved postoperative comfort and mental well-being.
The main objective of this study is to evaluate the efficacy of sessions of manual lymphatic
drainage to reduce postoperative edema.
Status | Completed |
Enrollment | 120 |
Est. completion date | October 2018 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 14 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Orthognathic surgery (mandibular osteotomy, maxillary osteotomy or both) - Providing informed consent. Exclusion Criteria: - Postoperative flexible restraint on the chin region. - Inability to understand and/or follow all scheduled visits. |
Country | Name | City | State |
---|---|---|---|
France | UH Montpellier | Montpellier | |
France | UH Tours | Tours |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Tours |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of edema using a centimeter scale. | Assessment in centimeter of the distance between the ear lobes passing under the bottom of the columella, through the chin and passing under the bottom edge of the chin and assessment in centimeter of the neck circumference at 7.5 cm below the lobes ears. | day 22 after surgery | |
Secondary | Comfort criteria | Comfort criteria (pain, aesthetic discomfort, difficulty in breathing and discomfort in swallowing) will be assessed by a self-administered questionnaire consisting of visual analogue scale(0-10). | Day 22 | |
Secondary | mental well-being. | The mental well-being will be assessed by the General Health Questionnaire in its 28 items french version (GHQ-28) | day 22 |
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