N/A N=43 Treatment

Fixed Lingual Mandibular Growth Modificator

Class II Division 1 Malocclusion · Retrognathic Mandible

Bottom Line

View on ClinicalTrials.gov: NCT01853137 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Nov 2020

Primary outcome: Primary: Total Mandibular Length (Co-Gn) — 3.51; 1.18 mm

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Fixed Lingual Mandibular Growth Modificator (FLMGM) (Device)
Age: Pediatric · 11+ yrs
Sex: All
Sponsor: Damascus University
Primary completion: Jul 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Total Mandibular Length (Co-Gn)	3.51; 1.18	—
SECONDARY Overjet Reduction	-3.32; 0.74	—

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.

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

View full record on ClinicalTrials.gov →

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.