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Completed

NCT Number: NCT06502041

MARPE Effect With/Without MOP in Non-growing Patients

This study compares the effect of MARPE (mini-implant assisted rapid palatal expansion) versus MARPE+ MOP (Micro-osteo-perforation) on nasal airway and maxillary transverse deficiency in non-growing patients.

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Key information

Conditions

Maxillary Transverse Deficiency

Age range

20 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, Adakhlia, Egypt

About this study

All participants with skeletal transverse deficiency with unilateral or bilateral cross-bite aging 20-25 years were treated by expansion of maxillary arch as a first phase of treatment with one expander screw which was anchored to mini-implants placed in the palatal region (Mini-implant assissted rapid palatal expansion; MARPE). The patient's bone support in the anterior area of the palate was examined on CBCT. Micro-osteoperforation (MOP) was done along of medial palatine raphe in the intervention group. Control-group is the same of the intervention group but without micro-osteo-perforations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • The age ranges from 20-25 years.
  • Post pubertal adolescent
  • Skeletal transverse deficiency with unilateral or bilateral cross-bite
  • Extraction is not indicated in the lower arch.
  • Upper permanent dentition is erupted up to the second molars.
  • Average facial vertical growth pattern.
  • Space deficiency in the upper arch is less than 8 mm

Exclusion criteria

  • Diseases and medications those are likely to affect bone biology.
  • Evidence of root resorption.
  • Poor oral hygiene.
  • Previous orthodontic treatment.
  • Evidence of bone loss.
  • Active periodontal disease.
  • Craniofacial congenital anomalies, such as cleft lip and palate.
  • Pregnant females. 8. Presence of oral habits.

Treatment and study plan

MARPE with MOP

Procedure

mini-screw assisted rapid palatal expansion with micro-osteoperforation

MARPE without MOP

Procedure

mini-screw assisted rapid palatal expansion without micro-osteoperforation

Primary outcomes

  1. Number of days till diastema appearance

    Time frame: about 1 month

    (days)

  2. Amount of skeletal expansion

    Time frame: about 1 month

    (mm)

  3. Pain experience during activation of expander by visual analogue scale ( VAS)

    Time frame: about 1 months

    VAS: 0 ( no pain), 10 (unbearable pain)

  4. Skeletal, Dental & Nasal readings

    Time frame: measured before treatment and after 6 month of treatment

    from CBCT and scanned models measured in degrees & mm

  5. Stability of correction of transverse deficiency

    Time frame: about 6 months

    by measuring the same CBCT transverse reading and by superimposition of the scaneed models at the end of the research

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

A Randomized Clinical Trial Comparing MARPE Effect With/Without MOP in Management of Skeletal Transverse Deficiency in Non-growing Patients

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 15, 2024
Registry last updated
Jul 15, 2024

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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