Mandibular Dental Crowding
Conditions
Keywords
Micro-osteoperforations, aligner tracking, lower anterior crowding, clear aligners
Brief summary
this randomized controlled trial is designed to compare between clear aligner therapy in alleviating mandibular anterior crowding alone versus with micro-osteoperforations
Detailed description
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
Interventions
DEVICEclear aligners 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
DEVICEmicro-osteoperforations group
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.
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
1. Adult patients with age ranging from 18 to 35 years. 2. Healthy periodontium. 3. Presence of full set of permanent dentition excluding third molars. 4. Patients requiring non-extraction orthodontic treatment in the mandibular arch. 5. Mandibular anterior little's irregularity index from 3 to 6. 6. No spaces in the mandibular arch.
Exclusion criteria
1. Presence of retained primary teeth in the mandibular arch. 2. Patients having systemic diseases as (e.g., diabetes, osteoporosis) or taking medication that could affect tooth movement (e.g., bisphosphonates, anticancer drugs) 3. Vulnerable patients. 4. Smokers. 5. Pregnant female patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| aligner effectivness | 3-9 months | Number of aligners prescribed versus required (total number of aligners including refinements) for each group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| relief of dental crowding | 3-9 months | relief of crowding will be assessed using Little's Irregularity Index |
| gingival assessment | 3-9 months | measuring gingival index before and after treatment |
| pain assessment | from day 1 to day 7 after micro-osteoperforations | evaluating pain experienced after micro-osteoperforation using Visula Analoge score (VAS) |
| periodontal assessment | 3-9 months | measuring periodontal pocket depth before and after teatment |
| tooth mobility assessment | 3-9 months | measuring mobility index before and after treatment |
Countries
Egypt
Outcome results
None listed