CompletedNot Applicable

Three-dimensional CBCT Analysis of Root Volume Changes Following Tooth-bone and Bone-borne Maxillary Expansion: A Pilot Study.

Italy21 participantsStarted 2023-03-01

Plain-language summary

External root resorption (ERR) is an undesired side effect observed after rapid maxillary expansion (RME). This study aimed to investigate changes in the root volume of maxillary permanent first molars after RME using tooth-borne and bone-borne devices with cone-beam computed tomography (CBCT) software analysis. The study included 21 patients (mean age 11.8 years ±0.79 years) with skeletal transverse maxillary deficiency, randomly allocated into three groups according to the type of expansion device: tooth-borne Hyrax (TB), bone-borne 4-miniscrew (BB4) and bone-borne 2-miniscrew (BB2). The same expansion screw and activation protocol were applied in all groups. A CBCT was carried out before treatment (T0) and after treatment at a 6-month follow-up (T1). The volumetric assessment of maxillary permanent first molars was performed using digital software, evaluating the mean root volume changes (mm3 and %) between T0 and T1 in each group (TB, BB4, BB2). The Wilcoxon test was used for intra-group comparisons and the Kruskal-Wallis test was used for inter-group comparisons. Significance was set at P≤0.05.

Who can participate

Sex

ALL

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

Inclusion Criteria: * Caucasian children in late mixed dentition or permanent dentition, * unilateral or bilateral transverse maxillary deficiency of at least 8 mm, * no previous orthodontic treatment, * good oral hygiene, * completion of apexification of permanent first molars, * availability of adequate pre-treatment and post-retention CBCT records Exclusion Criteria: * any systemic syndrome * acute oral infections

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

root volume changes of maxillary permanent first molars following the active expansion phase.

Timeframe: up to 14 months

Trial details

NCT IDNCT06912568

SponsorUniversity of Roma La Sapienza

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-01

View on ClinicalTrials.gov More Root Resorption trials

Plain-language summary

Who can participate

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.