Class II Division 1 MalocclusionNCT03328754
Comparative Evaluation of PowerScope and Forsus
A study testing Powerscope placed bilaterally for class II correction and Group 2 Forsus in people with Class II Division 1 Malocclusion, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial 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 . Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Class II Division 1 Malocclusion
- What is being tested?
- Powerscope placed bilaterally for class II correction and Group 2 Forsus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteIndia
- Study dates
- 10 Dec 2015to 15 Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 9Show fewer
- Positive pretreatment visual treatment objective (VTO).
- Minimum crowding in dental arches.
- Treatment completed without any permanent teeth extracted (excluding third molars).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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 .
Read the 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 .
- Conditions
- Class II Division 1 Malocclusion
- Being tested
- Powerscope placed bilaterally for class II correction, Group 2 Forsus
- Keywords
- Pitchfork, Class II malocclusion, PowerScope
- Medical subject headings
- Malocclusion, Angle Class II, Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Powerscope placed bilaterally for class II correctionDevice
Powerscope placed bilaterally for class II correction
Group 2 ForsusDevice
Forsus placed bilaterally for class II correction
| Study group | Role | What they receive |
|---|---|---|
| Group 1 Powerscope | Experimental | Powerscope placed bilaterally for class II correction Receives: Device: Powerscope placed bilaterally for class II correction |
| Group 2 Forsus | Experimental | Forsus placed bilaterally for class II correction Receives: Device: Group 2 Forsus |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in mandibular length
changes in mandibular length after intervention
Measured: 12 months
Secondary outcomes (2)
Evaluation of Patient comfort
questionnaire for evaluating discomfort during parafunctional activities
Measured: 12 months
Evaluation of Operator Convenience
operator convenience by evaluating time taken for placement of each appliance.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start10 Dec 2015
- Primary completion30 Nov 2016
- Study completion15 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II Division 1 MalocclusionStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparative evaluation of treatment effects of PowerScope and Forsus
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rekha Sharma, Study director, PGIDS Rohtak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328754
- Sponsor's protocol ID
- Rekha ortho
- Status last verified
- Oct 2017
- First submitted
- 17 Oct 2017
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03328754
- Acronym / sponsor ID
- Rekha ortho
- Conditions
- Class II Division 1 Malocclusion
- Keywords
- Pitchfork, Class II malocclusion, PowerScope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 10 Dec 2015 (actual)
- Primary completion
- 30 Nov 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 1 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Comparative evaluation of treatment effects of PowerScope and Forsus
| Arm | Type | Receives |
|---|---|---|
| Group 1 Powerscope | Experimental | Device: Powerscope placed bilaterally for class II correctionPowerscope placed bilaterally for class II correction |
| Group 2 Forsus | Experimental | Device: Group 2 ForsusForsus placed bilaterally for class II correction |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Patients in active growth period
- Skeletal Class II malocclusion
- Normal or mildly prognathic maxilla
- Retrognathic mandible.
- Increased overjet, not less than 5 mm.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Powerscope placed bilaterally for class II correctionPowerscope placed bilaterally for class II correction | Device | Group 1 Powerscope |
| Group 2 ForsusForsus placed bilaterally for class II correction | Device | Group 2 Forsus |
Primary outcome
changes in mandibular length
Time frame: 12 months
changes in mandibular length after intervention
2 secondary outcomes
Evaluation of Patient comfort
Time frame: 12 months
Evaluation of Operator Convenience
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- Individual participant dataSharing planned: Yes
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LLLLT vs Piezocision in Accelerating Orthodontic Canine Retraction
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EVALUATION OF TREATMENT CHANGES IN CLASS II DIVISION 1 MALOCCLUSION DURING EN MASSE RETRACTION OF UPPER ANTERIOR TEETH USING MINI IMPLANTS PLACED AT INFRAZYGOMATIC CREST AND INTERRADICULAR SITES A RANDOMIZED CLINICAL TRIAL.
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Comparison of Early Interceptive Orthodontic Appliances (Traditional and Novel) and Later Fixed Appliance Treatment in Class II Malocclusion.
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The Effectiveness of the Twin Block and Carriere Motion Appliances in Post-pubertal Patients and an Evaluation of the Impact of Class II Malocclusion and Its Correction on Oral Health-related Quality of Life
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rekha Sharma study director
PGIDS Rohtak
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Powerscope placed bilaterally for class II correction and Group 2 Forsus in people with Class II Division 1 Malocclusion, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in mandibular length (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017; AzTrials last refreshed its copy on 1 Nov 2026.