An interventional study of clear aligners group and micro-osteoperforations group in Mandibular Dental Crowding, sponsored by Ain Shams University. Active, not recruiting at 1 site in Egypt. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Ain Shams University · Not applicable, Interventional, and Treatment
this randomized controlled trial is designed to compare between clear aligner therapy in alleviating mandibular anterior crowding alone versus with micro-osteoperforations
This study is carried on in order to provide a method to enhance the predictability of clear aligner treatment. Loss of aligner tracking is one of the problems encountered during aligner treatment that results in increasing number of aligners required to complete treatment in addition to increasing the overall treatment time and cost. Micro-osteoperforation is a method for acceleration of orthodontic tooth movement and could be used to improve tooth movement and predictability of treatment with clear aligners. So this study is aimed to evaluate the efficiency of aligner treatment during alleviation of lower anterior crowding with and without micro-osteoperforations
Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
the control group that will receive clear aligner treatment for lower anterior treatment without micro-osteoperforations
Device: clear aligners group
the experimental group that will receive clear aligner treatment for lower anterior treatment with micro-osteoperforations using mini-implants for acceleration of tooth movement and improving aligner's tracking
Device: micro-osteoperforations group
patients with lower anterior crowding, after randomization and allocation, will receive intraoral scanning to create a digital model. using computer software, teeth segmentation, setup and stagging of tooth movement will be carried out. models for each stage of tooth movement will be three-dimentionally printed and the aligners will be thermoformed over each model. patients are instructed to wear each aligner for a week then continue to the next aligner till treatment is finished
Also known as: control group, group 1
patients having lower anteriro crowding, after randomization and allocation, aligners will be produced for them. patients in this group will receive micro-osteoperforation using mini-implants before wearing the first aligner and after one month from starting treatment.
Also known as: experimental group, group 2
aligner effectivness
Number of aligners prescribed versus required (total number of aligners including refinements) for each group
Time frame: 3-9 months
relief of dental crowding
relief of crowding will be assessed using Little's Irregularity Index
Time frame: 3-9 months
gingival assessment
measuring gingival index before and after treatment
Time frame: 3-9 months
pain assessment
evaluating pain experienced after micro-osteoperforation using Visula Analoge score (VAS)
Time frame: from day 1 to day 7 after micro-osteoperforations
periodontal assessment
measuring periodontal pocket depth before and after teatment
Time frame: 3-9 months
tooth mobility assessment
measuring mobility index before and after treatment
Time frame: 3-9 months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Ain Shams University