N/A
Completed N=43
Fixed Lingual Mandibular Growth Modificator
Class II Division 1 Malocclusion · Retrognathic Mandible
Source: ClinicalTrials.gov NCT01853137 ↗
Enrolled (actual)
43
Serious AEs
0.0%
Results posted
Nov 2020
Primary outcomePrimary: Total Mandibular Length (Co-Gn) — 3.51; 1.18 mm
Summary
The current trial was designed to investigate the possible initial net skeletal and dental effects of treatment with FLMGM by a comparative evaluation of treated and untreated Cl II/1 malocclusion subjects. The null hypothesis stated that there were no significant differences in dentofacial changes between FLMGM group and control group.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Mandibular Length (Co-Gn) |
3.51; 1.18 | — |
| SECONDARY Overjet Reduction |
-3.32; 0.74 | — |
Eligibility Criteria
Inclusion Criteria
Before treatment, each patient fulfilled the following criteria:
- Cl II/1 malocclusion with an overjet greater than 4 mm.
- Mild to moderate Class II Skeletal pattern (A-N-B > 4°) with retrognathic mandible (S-N-B < 76°).
- Growth potential. Fishman skeletal maturation indicator (SMI) method28 was used to assess the hand-wrist radiographs, and only patients in the peak of the pubertal growth spurt, which occurs on average between SMIs 4 to 7,29 at the beginning of the treatment/observation period were invited.
Exclusion Criteria
-
Data sourced from ClinicalTrials.gov (NCT01853137). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.