Comparative Evaluation of PowerScope and Forsus

NCT03328754 | Completed DMC

• 1 other identifier: Rekha ortho
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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 .

Conditions

Class II Division 1 Malocclusion

Keywords

Pitchfork; Class II malocclusion; PowerScope

Outcome Measures

Primary Outcomes (1)

• changes in mandibular length

  changes in mandibular length after intervention

  12 months

Secondary Outcomes (2)

• Evaluation of Patient comfort

  12 months

• Evaluation of Operator Convenience

  12 months

Study Arms (2)

Group 1 Powerscope

EXPERIMENTAL

Powerscope placed bilaterally for class II correction

Device: Powerscope placed bilaterally for class II correction

Group 2 Forsus

EXPERIMENTAL

Forsus placed bilaterally for class II correction

Device: Group 2 Forsus

Interventions

Powerscope placed bilaterally for class II correction DEVICE

Powerscope placed bilaterally for class II correction

Group 1 Powerscope

Group 2 Forsus DEVICE

Forsus placed bilaterally for class II correction

Group 2 Forsus

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

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:

• 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

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

Post Graduate Institute of Dental Sciences

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Conditions

Malocclusion, Angle Class II; Overbite

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Rekha Sharma

  PGIDS Rohtak

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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..
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparative evaluation of treatment effects of PowerScope and Forsus

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: November 1, 2017
• Study Start: December 10, 2015
• Primary Completion: November 30, 2016
• Study Completion: December 15, 2016
• Last Updated: November 1, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

IN (1)