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Completed

NCT Number: NCT05167708

Effects of Micro-osteoperforation on the Maxillary First Molar Distalization

the study aimed to evaluate the effect of different types of Micro-osteoperforation on the rate of distal movement of maxillary first molars as a primary out come. Besides, it was aimed to study secondary effect on the first molars by evaluating root resorption, bone density, and level of the pain during performing the procedures.

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Key information

Age range

16 year–20 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

About this study

in the study, investigators tried to evaluate two methods to accelerate tooth movement by comparing them with control group. the first method was to apply one-time micro-osteoperforation. the second method was to apply the micro-osteoperforation repeatedly till reaching the end of the phase one treatment.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Space deficiency in the upper arch > 5 mm, and < 8 mm.
  • Non-extraction lower arch.
  • Full upper dentition up to the second molars.
  • Third molar present in both sides, not yet erupted.

Exclusion criteria

  • Systemic disease or syndrome.
  • Evidence of root resorption.
  • Poor oral hygiene.
  • Previous orthodontic treatment
  • Evidence of bone loss.
  • Active periodontal disease.
  • Pregnant females.
  • Presence of oral habits

Treatment and study plan

micro-osteoperforation

Procedure

flapless small punctures in the bone at direction of tooth movement to accelerate the movement.

Primary outcomes

  1. rate of maxillary first molar distal movement

    Time frame: through study completion, an average 1 year

    evaluation of the whole rate of distal movement of the first molar

Secondary outcomes

  1. decrease in length of maxillary first molars in mm.

    Time frame: through study completion, an average 1 year

    the change in the lengths of roots of maxillary first molars in mm.

  2. bone density

    Time frame: through study completion, an average 1 year

    bone density around the first molar

  3. pain perception questionnaire

    Time frame: through study completion, an average 1 year

    evaluate the pain perception to the intervention

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

The Effect of Single and Repeated Micro-osteoperforation on the Maxillary First Molar Distalization: A Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 22, 2021
Registry last updated
Dec 22, 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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