Comparative Evaluation of PowerScope and Forsus
Primary Purpose
Class II Division 1 Malocclusion
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Powerscope placed bilaterally for class II correction
Group 2 Forsus
Sponsored by
About this trial
This is an interventional treatment trial for Class II Division 1 Malocclusion focused on measuring Pitchfork, Class II malocclusion, PowerScope
Eligibility Criteria
Inclusion Criteria:
- 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).
Exclusion Criteria:
- Subjects with a history of orthodontic treatment
- 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
Sites / Locations
- Post Graduate Institute of Dental Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group 1 Powerscope
Group 2 Forsus
Arm Description
Powerscope placed bilaterally for class II correction
Forsus placed bilaterally for class II correction
Outcomes
Primary Outcome Measures
changes in mandibular length
changes in mandibular length after intervention
Secondary Outcome Measures
Evaluation of Patient comfort
questionnaire for evaluating discomfort during parafunctional activities
Evaluation of Operator Convenience
operator convenience by evaluating time taken for placement of each appliance.
Full Information
NCT ID
NCT03328754
First Posted
October 17, 2017
Last Updated
October 28, 2017
Sponsor
Postgraduate Institute of Dental Sciences Rohtak
1. Study Identification
Unique Protocol Identification Number
NCT03328754
Brief Title
Comparative Evaluation of PowerScope and Forsus
Official Title
Comparative Evaluation of Treatment Effects of PowerScope and Forsus Fixed Functional Appliance in Correction of Class II Malocclusion: A Single Centre Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
December 10, 2015 (Actual)
Primary Completion Date
November 30, 2016 (Actual)
Study Completion Date
December 15, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Postgraduate Institute of Dental Sciences Rohtak
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this 2-arm parallel double blinded randomized controlled trial is was to evaluate and compare the treatment effects of PowerScope and Forsus in the treatment of Class II division 1 malocclusion. Patient comfort and operator convenience was also assessed and compared .
Detailed Description
INTRODUCTION : Among different dental and skeletal combinations that can create a Class II malocclusion, mandibular retrusion is one of the most common characteristics.In such cases, to stimulate mandibular growth by forward positioning of the mandible, various removable and fixed functional appliances are commonly used to alter the position of mandible during the pubertal growth period.
Stimulation of mandibular growth, distal movement of upper dentition, mesial movement of lower dentition contributes to correction of Class II malocclusion with the use of fixed functional appliances. Of the various fixed functional appliances available to the orthodontist today for the correction of Class II malocclusion are Forsus fatigue resistant device which is the most popular fixed functional appliance6 and the PowerScope which is a recent addition to the armamentarium.
PowerScope is delivered as a one-size-fits-all appliance pre-assembled with attachment nuts for quick and easy chairside application. The appliance is a wire-to-wire installation with attachments placed mesial to the first molar in the maxillary arch and distal to the canine of the mandibular arch. Although there are a few case reports in the literature showing the treatment effects and clinical application of PowerScope, there is not a single study mentioning the effects of PowerScope appliance, which has a different status from other fixed functional appliances due to its special attachment. The purpose of this clinical study was to evaluate the skeletal and dental changes produced by the PowerScope and compare these effects with one of the most commonly used fixed functional appliance the Forsus Fatigue Resistant Device (FRD).
MATERIALS AND METHODS: The present study is a prospective, non-pharmacological, double blind, randomised clinical study conducted in the department of Orthodontics and Dentofacial orthopedics, PGIDS Rohtak.
The study sample consisted of 28 patients, were selected from subjects reporting to the department for fixed orthodontic treatment.
The primary researcher explained the nature of the study to the patients and their parents and their consent was taken. The final sample of 28 patients fulfilling the criteria were randomly divided in two groups: Group 1( PowerScope group) and Group 2 (Forsus group) All subjects in both the treatment groups were treated with MBT 0.022- inch slot preadjusted edgewise appliance (Ortho Organizers, San Marcos, Calif). Both arches were levelled and aligned upto 0.019" ×0.025" stainless steel wires and then the fixed functional appliance as per the group mentioned in the patients envelop was installed.
Lateral cephalometric radiographs were taken before starting fixed functional appliance therepy( T1) immediately (1-3 days) before placement of the fixed functional appliance (T2) and after removal of the fixed functional appliance(T3). All cephalometric radiographs were taken on the same cephalostat.
For evaluation of skeletal and dentoalveolar changes that contributed to the Class II correction, pitchfork analysis was used.
To check patient comfort, all the patients were given a questionnaire. The questionnaire was designed in English and then verbally translated into the patients and parents native language at the installation appointment though all the patients and their parents could read and understand it in English. After the installation all the patients were given the questionnaire and requested to bring it at the next scheduled appointment after filling the required details .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class II Division 1 Malocclusion
Keywords
Pitchfork, Class II malocclusion, PowerScope
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Comparative evaluation of treatment effects of PowerScope and Forsus
Masking
ParticipantOutcomes Assessor
Masking Description
Randomization was done with Simple Randomisation method to ensure 1:1 allocation ratio and allocation concealment was achieved with similar looking sealed opaque envelopes. The name of the groups 'Forsus' and 'PowerScope' were written on 13 pieces of paper resulting in total 26 pieces of paper which were folded and shuffled in a box, then taken out and without opening put in 26 opaque envelopes which were then sealed and kept again in the box. The envelopes were shuffled inside the box each time the patient was asked to pick one envelope from the box .The patient was assigned to the group mentioned in the envelope which was opened by the primary investigator who was not involved in data analysis..
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 Powerscope
Arm Type
Experimental
Arm Description
Powerscope placed bilaterally for class II correction
Arm Title
Group 2 Forsus
Arm Type
Experimental
Arm Description
Forsus placed bilaterally for class II correction
Intervention Type
Device
Intervention Name(s)
Powerscope placed bilaterally for class II correction
Intervention Description
Powerscope placed bilaterally for class II correction
Intervention Type
Device
Intervention Name(s)
Group 2 Forsus
Intervention Description
Forsus placed bilaterally for class II correction
Primary Outcome Measure Information:
Title
changes in mandibular length
Description
changes in mandibular length after intervention
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Evaluation of Patient comfort
Description
questionnaire for evaluating discomfort during parafunctional activities
Time Frame
12 months
Title
Evaluation of Operator Convenience
Description
operator convenience by evaluating time taken for placement of each appliance.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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).
Exclusion Criteria:
Subjects with a history of orthodontic treatment
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rekha Sharma
Organizational Affiliation
PGIDS Rohtak
Official's Role
Study Director
Facility Information:
Facility Name
Post Graduate Institute of Dental Sciences
City
Rohtak
State/Province
Haryana
ZIP/Postal Code
124001
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Yes
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Comparative Evaluation of PowerScope and Forsus
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