deltatrials
Terminated NA INTERVENTIONAL 2-arm NCT00957489

A Prospective Randomized Controlled Trial to Evaluate the Effectiveness of the Two Different Appliances in the Treatment of Class II Division 1 Malocclusion

Sponsor: National Health Service, United Kingdom

Updated 5 times since 2017 Last updated: May 14, 2023 Started: Jan 31, 2007 Primary completion: Sep 30, 2008 Completion: Sep 30, 2008
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Study stopped due to increased harm and slow progress in the intervention group.

This NA trial investigates Class II Division 1 Malocclusion and is currently terminated or withdrawn. National Health Service, United Kingdom leads this study, which shows 5 recorded versions since 2007 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

The Dynamax appliance is a relatively new appliance for the treatment of Class II malocclusion and was introduced in 2003. The appliance has the theoretical advantages of incremental mandibular advancement without the need for bite registration, and the ability for the operator to simultaneously provide the functional and fixed appliance phases of treatment. Furthermore, the Dynamax appliance is designed to limit lower both lower incisor proclination and upper incisor retroclination without an increase in lower facial height. There has been limited research into this appliance and only one trial has been carried out. In this study the effects of the Dynamax were compared with the Twin-block, unfortunately, the trial was not carried out to contemporary standards and suffered from severe shortcomings. For example, the non compliance rate was not accounted for in the sample size calculation, the randomisation sequence was not clear, the investigators did not carry out an intention-to-treat analysis, the statistical analysis was simplistic and the study was carried out in a single dental school setting. This raises the question about the efficiency of the Dynamax appliance and whether or not they are effective in a 'real' world setting. The aim of this study is to compare the...

The Dynamax appliance is a relatively new appliance for the treatment of Class II malocclusion and was introduced in 2003. The appliance has the theoretical advantages of incremental mandibular advancement without the need for bite registration, and the ability for the operator to simultaneously provide the functional and fixed appliance phases of treatment. Furthermore, the Dynamax appliance is designed to limit lower both lower incisor proclination and upper incisor retroclination without an increase in lower facial height. There has been limited research into this appliance and only one trial has been carried out. In this study the effects of the Dynamax were compared with the Twin-block, unfortunately, the trial was not carried out to contemporary standards and suffered from severe shortcomings. For example, the non compliance rate was not accounted for in the sample size calculation, the randomisation sequence was not clear, the investigators did not carry out an intention-to-treat analysis, the statistical analysis was simplistic and the study was carried out in a single dental school setting. This raises the question about the efficiency of the Dynamax appliance and whether or not they are effective in a 'real' world setting.

The aim of this study is to compare the effectiveness of the Dynamax appliance and the Twin-block appliance for the treatment of Class II Division 1 malocclusion.

Status Flow

~Jan 2017 – ~Jan 2021 · 48 months · monthly snapshotTerminated~Jan 2021 – ~Jun 2023 · 29 months · monthly snapshotTerminated~Jun 2023 – ~Jul 2024 · 13 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 19 months · monthly snapshotTerminated

Change History

5 versions recorded
  1. Sep 2024 — Present [monthly]

    Terminated NA

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated NA

  3. Jun 2023 — Jul 2024 [monthly]

    Terminated NA

  4. Jan 2021 — Jun 2023 [monthly]

    Terminated NA

  5. Jan 2017 — Jan 2021 [monthly]

    Terminated NA

    First recorded

Jan 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Health Service, United Kingdom
  • University of Manchester
Data source: University of Manchester

For direct contact, visit the study record on ClinicalTrials.gov .