Trial Outcomes & Findings for Fixed Lingual Mandibular Growth Modificator (NCT NCT01853137)

NCT ID: NCT01853137

Last Updated: 2020-11-12

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 43 participants
• Primary outcome timeframe: 8 months
• Results posted on: 2020-11-12

Participant Flow

patients were recruited from those referred to the department of Orthodontics at the University of Damascus between May 2009 and June 2011.

Participant milestones

Measure	FLMGM Treatment Group Fixed Lingual Mandibular Growth Modificator (FLMGM) : Novel Class II functional appliance, a fixed version of double-plate appliance	Untreated Class II Control Group
Overall Study STARTED	25	18
Overall Study COMPLETED	21	17
Overall Study NOT COMPLETED	4	1

Reasons for withdrawal

Measure	FLMGM Treatment Group Fixed Lingual Mandibular Growth Modificator (FLMGM) : Novel Class II functional appliance, a fixed version of double-plate appliance	Untreated Class II Control Group
Overall Study Lost to Follow-up	4	1

Baseline Characteristics

Fixed Lingual Mandibular Growth Modificator

Baseline characteristics by cohort

Measure	FLMGM Treatment Group n=25 Participants Fixed Lingual Mandibular Growth Modificator (FLMGM) : Novel Class II functional appliance, a fixed version of double-plate appliance	Untreated Class II Control Group n=18 Participants	Total n=43 Participants Total of all reporting groups
Age, Categorical <=18 years	25 Participants n=93 Participants	18 Participants n=4 Participants	43 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	13.2 years STANDARD_DEVIATION 0.9 • n=93 Participants	12.5 years STANDARD_DEVIATION 2.1 • n=4 Participants	13.0 years STANDARD_DEVIATION 1.3 • n=27 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	10 Participants n=4 Participants	24 Participants n=27 Participants
Sex: Female, Male Male	11 Participants n=93 Participants	8 Participants n=4 Participants	19 Participants n=27 Participants
Region of Enrollment Syrian Arab Republic	25 participants n=93 Participants	18 participants n=4 Participants	43 participants n=27 Participants

PRIMARY outcome

Timeframe: 8 months

Outcome measures

Measure	FLMGM Treatment Group n=21 Participants Fixed Lingual Mandibular Growth Modificator (FLMGM) : Novel Class II functional appliance, a fixed version of double-plate appliance	Untreated Class II Control Group n=17 Participants This is a group of patients classified as Class II patients but they are not treated during the observation period of this study
Total Mandibular Length (Co-Gn)	3.51 mm Standard Deviation 1.37	1.18 mm Standard Deviation 1.13

SECONDARY outcome

Timeframe: 8 months

Outcome measures

Measure	FLMGM Treatment Group n=21 Participants Fixed Lingual Mandibular Growth Modificator (FLMGM) : Novel Class II functional appliance, a fixed version of double-plate appliance	Untreated Class II Control Group n=17 Participants This is a group of patients classified as Class II patients but they are not treated during the observation period of this study
Overjet Reduction	-3.32 mm Standard Deviation 2.86	0.74 mm Standard Deviation 0.94

Adverse Events

FLMGM Treatment Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Untreated Class II Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.

Osama AlAli

Phone: 00963992262582

Email: osama-alali@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place