Effect of Micro-osteo-perforations on the Rate of Alignment of Mandibular Anterior Teeth.
Microosteoperforations
Treatment Study
Summary
Study start date: January 1, 2021
Actual date on which the first participant was enrolled.MATERIAL AND METHODS: STUDY DESIGN: Two parallel arm randomized controlled clinical trial SETTING: Orthodontics Department, Rehman College of Dentistry. DURATION OF STUDY: one year SAMPLING TECHNIQUE: non-probability consecutive sampling. SAMPLE SELECTION: INCLUSION CRITERIA 1. Malocclusion cases with mandibular anterior segment crowding. 2. Age range 13-30 years. EXCLUSION CRITERIA: 1. Missing lower anterior tooth. 2. Systemic diseases/Medications affecting bone biology. 3. Previous orthodontic treatment. 4. Poor oral hygiene status. 5. Active periodontal disease 6. Syndromes. DATA COLLECTION Written informed consent from the patients will be taken after clarification of the purpose of the intervention and the associated risks and benefits. Orthodontic treatment will be started in all subjects using fixed preadusted edgewise appliance (0.022-in MBT prescription, Ortho Organizers, Inc. USA). After bonding of lower arch the patients will be randomized into control and experimental groups. Patients will be randomly allocated, through computer generated tables in Microsoft Excel Software, into parallel groups with a 1:1 allocation ratio. Allocation will be concealed in opaque envelopes and opened only at the time of intervention. Local anesthesia will be given in lower arch on each side approximately 1cm from labial frenum. Two points for screw insertion will be demarcated on buccal mucosa, in each interdental segment, by bleeding points using a calibrated periodontal probe. Probe tip will be inserted to the level of bone to measure the thickness of gingiva. The measurement will be added to the depth of perforation needed i-e 2 - 3 mm into the bone. First point will be marked at a distance of 3mm from free gingival margin and second point will be marked 3mm from the first one. Orthodontic miniscrew (AbsoAnchor, Korea) of 1.3 mm diameter will be used for MOPs to the depth of 2-3 mm into the buccal cortical bone. An endodontic rubber stopper will be set for required / optimal depth on miniscrew and MOPs will be performed. After the intervention, the patients will be instructed for maintaining good oral hygiene and to take analgesics, such as acetaminophen, only if necessary. The control group will receive no MOPs at the alignment stage. Alignment will be started in both control and experimental groups using 0.012 NiTi (North American Braces, USA). Both the groups will be followed every month for maximum six months. Digital scan of lower arch will be taken on each visit. Each scan will be labelled for identification, date of scan taking and little index score .For reliability 20 randomly selected scan will be rescored for little index by the same examiner as well as another examiner after 2 weeks for intra and inter-examiner reliability.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.30 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 13 to 30 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location