CompletedNot Applicable

Efficacy of Skeletally Anchored Modified Leaf Expander in Maxillary Molar Distalization

Egypt30 participantsStarted 2024-01-15

Plain-language summary

Background: Distalization in orthodontics is one of conservative treatment modalities that result in gaining space especially in dental orthodontic cases of class ΙΙ molar relationship. Aim: This study aimed to compare the distalization effects of the skeletally anchored modified Leaf Expander versus the skeletally anchored modified conventional Hyrax Expander. Patients and Methods: Thirty patients (15-18 years) requiring maxillary molar distalization were randomly allocated into two groups (n = 15 each). Group 1 received the modified skeletally anchored self-activated Leaf Expander, and Group 2 received the modified skeletally anchored conventional Hyrax Expander. Pre- and post-distalization lateral cephalometric radiographs and digital dental models were analyzed for skeletal, dental, and arch dimensional changes. Treatment duration and adverse events were also recorded. Statistical analysis included paired t-tests and independent t-tests, with Bonferroni correction (α = 0.0045) applied for multiple comparisons. Effect sizes (Cohen's d) were calculated to assess clinical relevance. .

Who can participate

Age range

15 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * • Class II molar relation. * Patients aged between 15 and 18 years. * Overjet less than 6 mm * ANB angle between 5° and 7°. * Non-extraction treatment plan with molar distalization. * Horizontal or normal growth pattern with symmetrical, balanced facial appearance. * Minimal crowding in the mandibular arch. Exclusion Criteria: * Congenitally missing teeth * Congenital anomalies * Systemic diseases * Previous orthodontic treatment

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Arch length

Timeframe: six months

Inter-canine width

Timeframe: six months

Inter-first premolar width

Timeframe: six months

Inter-second premolar width

Timeframe: six months

Inter-first molar width

Timeframe: six months

Trial details

NCT IDNCT07534072

SponsorAl-Azhar University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-07-14

View on ClinicalTrials.gov More Orthodontic Patients trials

Plain-language summary

Who can participate

Age range

15 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.