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NCT Number: NCT04921579

Evaluation of Treatment Duration of En-masse Versus Two Steps Retraction in Patients Having Maxillary Protrusion

Brief summary: there's a scarcity in literature concerning time needed to retract anterior segment following premolars extraction. the purpose of this study is to determine, in orthodontic patients with maxillary protrusion, which form of technique of retraction offers a faster treatment duration of retraction : en-masse or two step techniques

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Key information

Conditions

Bimaxillary Protrusion

Age range

14 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Future University

Cairo, 11835, Egypt

About this study

Anterior segment retraction can be done in one of two ways: through En masse or two step techniques. Both are viable options, but, ideally, the investigator wanted to retract and complete the orthodontic treatment as quickly as possible, in order to decrease the negative effects that may occur during treatment. Which of these techniques results in a decreased treatment time is still up for debate.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults and adolescent patients ( both gender)
  • Age range (14- 24)
  • patient with maxillary protrusion requiring first premolars extraction ( bimaxillary protrusion or class II division 1 cases)
  • patients with fully erupted permanent teeth ( not necessarily including the third molar).
  • cases required maximum anchorage during retraction.
  • good general and oral health

Exclusion criteria

  • patients suffering from any systemic diseases interfering with tooth movement.
  • patients with extracted or missing permanent teeth (except for third molars).
  • patients with badly decayed teeth.
  • patients with any parafunctional habits ( i.e. Bruxism, tongue thrusting, mouth breathing, etc.,.....)
  • patients with previous orthodontic treatment

Treatment and study plan

En masse retraction

Procedure

Retraction stated on a 0.017''x 0.025'' Stainless steel wire using elastomeric chain ( force applied 200 g per side) extending between the crimpable hooks and the mini-screw.

Two-Step retraction

Procedure

Retraction of canine started on a 0.017''x0.025'' Stainless steel wire using elastomeric chain ( force applied 150 g per side) followed by anterior teeth retraction on 0.017''x0.025'' Stainless steel wire using elastomeric chain ( force applied 160 g per side) extending between crimpable hooks and the mini-screw.

Primary outcomes

  1. Time to close extraction space

    Time frame: from pre to post retraction ( an average of 10 - 12 months)

    the antero-posterior movement of anterior teeth are assessed by monthly taken models and patient record sheets

Secondary outcomes

  1. Anchorage loss

    Time frame: From pre to post retraction ( an average of 10- 12 months)

    Digitalized dental models taken before and after completion of retraction will be measured by identifying landmarks and reference lines and planes ( measured in mm)

  2. pain of intervention

    Time frame: From pre to post retraction ( an average of 10 - 12 months)

    Each patient was informed to fill a questionnaire regarding treatment experience in Visual analogue scale scoring from (0 -10) 0 means no pain and 10 means severe pain

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study title

Evaluation of Treatment Duration of En-masse Versus Two Steps Retraction in Patients Having Maxillary Protrusion: A Randomized Clinical Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 10, 2021
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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