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Completed

NCT Number: NCT04458506

Treatment of Unilateral Posterior Cross Bite in Children

Rapid maxillary expansion and quad-helix are two well established appliances in dentistry used for posterior cross bite treatment. This study aims to compare this two different appliances in patients in their early mixed dentition, regarding treatment effects of the extra oral soft tissue but also dental and skeletal effects, if the children experience any pain and discomfort during treatment and the study also aims to make a cost minimization analysis. Comparison of these different treatments are barely made and no randomized controlled trial is yet published. No study has evaluated the difference of subjective experience during these two treatments. After this study we will know which one of these two appliances are the most effective, regarding cost minimization and treatment result but we are also able to put it in relation to the patients subjective experience

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Key information

Conditions

Malocclusion Maxillary Expansion Pain Children Stomatognathic Diseases Tooth Diseases

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Postgraduate Dental Education Center

Örebro, SE-70111, Sweden

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Children in the early mixed dentition
  • Unilateral posterior cross bite including the first permanent molar

Exclusion criteria

  • No ongoing sucking habits
  • Craniofacial syndroms
  • Earlier Orthodontic treatments
  • Not able to independently understand and answer the questionnaires

Treatment and study plan

Maxillary expansion

Procedure

Correction of the unilateral posterior cross bite in children

Primary outcomes

  1. Skeletal expansion at the level of the palatal median suture - the change fram Baseline

    Time frame: At baseline, directly after expansion and one year after expansion

    Skeletal expansion evaluated by computed tomography at three time points in both arms. The change in width of the palatal median suture is going to be evaluated and compared to the Baseline values, in both arms.

  2. The change of inclination of teeth and alveolar bone and side effects between the time points

    Time frame: At baseline, directly after expansion and one year after expansion

    Dental effects and side effects evaluated by computed tomography at three time points in both arms.The change in degree of angulation and inclination of the dental structures (e.g. tooth inclinations) is going to be evaluated and compared to the Baseline values, in both arms.

Secondary outcomes

  1. Assessment of the soft tissue changes

    Time frame: At baseline, directly after expansion, six months and one year after expansion

    3D assessment of the soft tissue changes during and after treatment by 3D -photography

  2. Evaluation of pain and discomfort

    Time frame: Three times during the first week after inserting the appliances

    Questionnaire The Questionnaire has some questions with Visual Analogue Scale. With the minimum value of "0" and maximum value of "10". Higher values mean worse outcome.

    Other questions in the questionnaire have a "yes" and "No" nature.

  3. Evaluation of Temporomandibular Disorder (TMD)

    Time frame: Baseline and one year after expansion

    Questionnaire The questionnaire has no scale and the questions have a "Yes" och "No" nature.

  4. Cost-effectiveness of two treatment modalities in treatment of posterior cross bite

    Time frame: Through study completion, an average of 18 months

    Evaluation of both the direct and indirect costs of the treatment, number of emergency visits, treatment duration (in total) etc are going to be evaluated.

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Collaborators

  • Region Jönköping County

Registry information

Official study title

Treatment of Unilateral Posterior Cross Bite in the Mixed Dentition; a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 7, 2020
Registry last updated
Nov 18, 2023

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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