Comparison of Treatment Effects of PowerScope2 and Forsus Using CBCT
"Evaluation of Treatment Effects of Two Different Fixed Functional Appliances in Patients With Class II Div 1 Malocclusion Using CBCT- A Randomized Controlled Clinical Study"
1 other identifier
interventional
42
1 country
1
Brief Summary
The main objective of this prospective, controlled clinical study is:
- 1.To compare the treatment effects of PowerScope2 and Forsus Fatigue Resistant Device in patients with Class II divison1 malocclusion.
- 2.To compare the treatment effects of PowerScope2 and Forsus Fatigue Resistant Device with the control group.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 16, 2016
CompletedFirst Submitted
Initial submission to the registry
September 9, 2017
CompletedFirst Posted
Study publicly available on registry
September 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedApril 29, 2019
April 1, 2019
1.6 years
September 9, 2017
April 26, 2019
Conditions
Outcome Measures
Primary Outcomes (6)
mandibular length
changes in mandibular length after intervention
20 months
oropharyngeal volume
changes in oropharyngeal volumes after intervention
20 months
condylar changes
condylar changes after intervention
20 months
patient experiences
patient experiences with Forsus and PowerScope
20 months
pancherz analysis
pancherz analysis after intervention
20 months
soft tissue changes
soft tissue changes after intervention
20 months
Study Arms (2)
PowerScope2 group (G1)
ACTIVE COMPARATORClass II correction using PowerScope2
Forsus group (G2)
ACTIVE COMPARATORClass II correction using Forsus
Interventions
Eligibility Criteria
You may qualify if:
- Patients in active growth period
- Skeletal Class II malocclusion
- Normal or mildly prognathic maxilla
- Retrognathic mandible.
- Increased overjet, not less than 5 mm.
- Horizontal to average growth pattern
- Positive pretreatment visual treatment objective (VTO).
- Minimum crowding in dental arches.
- Treatment completed without any permanent teeth extracted (excluding third molars).
You may not qualify if:
- Anterior open bite
- Severe proclination and crowding of anterior teeth
- Any systemic disease affecting bone and generalgrowth
- Vertical growth pattern
- Patient who fails to follow up or undergo complete treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sonal Chowdhary
POST GRADUATE INSTITUTE OF DENTAL SCIENCES
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2017
First Posted
September 28, 2017
Study Start
August 16, 2016
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
April 29, 2019
Record last verified: 2019-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL