Facial Asymmetry Clinical Trial
Verified date | June 2013 |
Source | Università degli Studi di Sassari |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ministry of Health |
Study type | Interventional |
The specific aims of the study were to measure and compare the rates of alignment and cant reduction of the dental and facial midlines among the two groups.
Status | Completed |
Enrollment | 20 |
Est. completion date | January 2012 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years to 54 Years |
Eligibility |
Inclusion Criteria: - facial asymmetry or mandibular deviation (cant of the occlusal plane > 3° and/or midline discrepancies > 2.5 mm) - presence of all central incisors, - pre- and postoperative radiographs and plaster casts (group 1) - cranial CBCT images (group 2) - pre- and postoperative digital photographs. Exclusion Criteria: - previous trauma involving the hard or soft facial tissues - functional deviation of the mandible - incomplete records (CBCT, radiographs, casts or digital photographs). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Italy | Maxillofacial Unit, University of Sassari | Sassari | SS |
Lead Sponsor | Collaborator |
---|---|
Università degli Studi di Sassari |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in linear measures | More specifically were measured: distance from the upper interincisal point to the facial midline; distance from the lower interincisal point to the facial midline; distance between interincisal points; distance from skeletal menton to the facial midline; distance from soft tissue menton to the facial midline; | Preoperative (baseline)-Postoperative (up to 1 month) | Yes |
Primary | Change in angular measures | More specifically were measured:distance from the maxillary sagittal plane to the facial mid-sagittal plane; distance from the mandibular sagittal plane to the facial mid-sagittal plane. | Preoperative (baseline)- Postoperative (up to one month) | Yes |
Secondary | age of patients | age at surgery | Preoperative (baseline) | No |
Secondary | Type of surgery needed | How many patients had genioplasty added to the standard bimaxillary surgery plan | Preoperative (baseline) | No |
Secondary | sample size | number of patients | Preoperative (baseline) | No |
Secondary | gender | male/female | Preoperative (baseline) | No |
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