Effects of Micro-osteoperforations on Lower Anterior Crowding Using Clear Aligners

N/AActive Not RecruitingNCT07169968

Ain Shams University20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Mandibular Dental Crowding

Interventions

clear aligners groupDEVICE

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

micro-osteoperforations groupDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Department of orthodontics, Faculty of Dentistry, Ain Shams University

Cairo, Abassia, Egypt

Outcomes

Primary Outcomes

aligner effectivness

Number of aligners prescribed versus required (total number of aligners including refinements) for each group

Time frame: 3-9 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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