An Evaluation of the Efficacy of Conventional Corticotomy Versus Flapless Corticotomy in the En-Masse Retraction of Upper Anterior Teeth : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Duration of en-masse retraction of anterior teeth
研究概览
简要总结
This study aims to evaluate and compare the skeletal, dental and soft tissue changes, the levels of pain and discomfort and the effect on periodontal health and teeth vitality associated to traditional corticotomy and flapless corticotomy in the retraction of upper anterior teeth.
40 patients requiring extraction of maxillary first premolars and maximum anchorage to retract the upper anterior teeth will participate in the study. They will be divided randomly into two groups : flapless corticotomy (20 patients) and traditional corticotomy (20 patients). Pre-retraction, corticotomy will be performed in the maxillary anterior segment. The skeletal, dental and soft tissue changes will be performed using lateral cephalometric radiographs which will be obtained pretreatment, pre and post en-masse retraction of the anterior teeth and we will also use the dental casts to evaluate the dental changes.
详细描述
A corticotomy is cutting of the bone involves cortical bone only, leaving intact the medullary vessels and periosteum It offers an advantage to adult patients in reduction the orthodontic treatment time. The definition of traditional corticotomy is: elevating full-thickness periodontal flaps from a coronal approach, and vertical corticotomies are made between the teeth extending from 2-3 mm apical of the alveolar crest to 2 mm beyond the tooth apices and connected by a horizontal corticotomy; this process is done on both the labial and palatal aspects.
The definition of flapless corticotomy is: a minimally invasive version of corticotomy, using a piezotome in order to inflict bone injury. This technique entails labial and palatal interproximal piezoelectric microincisions into the cortical bone, without reflecting periodontal flaps.
Prior to enrollment of each subject into the study, they will be examined completely to determine the orthodontic treatment plan. The operator will inform them about the aim of the study and ask them to provide a written informed consent.
Self-drilling titanium mini-implants (1.6mm diameter and 8mm length) will be used. they will be inserted between the maxillary second premolar and first molar at approximately 8-10mm above the archwires at the mucogingival junction and will be checked for primary stability (mechanical retention). Then the maxillary first premolar will be extracted. The maxillary arch will be levelled and aligned. The rectangular stainless steel archwires (0.019" × 0.025") with anterior 8mm height soldered hooks distal to the lateral incisors will be inserted.
The surgery will be carried out under local anesthesia. The traditional corticotomy will be handled by the same maxillofacial surgeon and the flapless corticotomy will be handled by the same orthodontist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with permanent occlusion at age 18-30 years.
- •Comprehensive medical and dental history ruling out any systemic disease
- •Not under any systemic medication.
- •No previous orthodontic treatment
- •Patients with satisfactory periodontal health and Good oral hygiene
- •Need to orthodontic treatment with fixed appliances
- •No congenitally missing teeth except third molars in the maxillary arch
- •Mild or no anterior crowding in maxillary arch.
- •Maximum anchorage, with 75% to 100% of space closure of retraction of anterior segment in maxillary arch.
- •Therapeutic extraction of maxillary first premolars required.
- •Patients with class Ⅱ division 1 (ANB angle ≤7 degrees) with severe overjet (5-10 mm)
- •Maximum retraction of the anterior teeth was desired.
排除标准
- •Patients with previous orthodontic treatment.
- •Patients with severe skeletal dysplasia in all three dimensions.
- •Patients suffer from systemic diseases or syndromes
- •Patients on medication for systemic disorders, pregnancy or steroid therapy.
- •Patients showing any signs of active periodontal disease
- •Patients with severe crowding (≥ 3.5 mm) in maxillary arch
- •Patients with missing or extracted teeth in maxillary arch except third molar.
研究组 & 干预措施
Flapless corticotomy
Flapless corticotomy will be conducted in this group of patients.
干预措施: Flapless corticotomy surgical intervention will be conducted (Procedure)
Traditional corticotomy
Traditional corticotomy will be performed in this group.
干预措施: Traditional corticotomy (Procedure)
结局指标
主要结局
Duration of en-masse retraction of anterior teeth
时间窗: The months required to compete the retraction procedure will be recorded. Completion of this procedure is expected to be occur within six months in the experimental group and eight months in the control group.
Assessment will be performed by calculating the months required to achieve complete retraction of the upper anterior teeth (six teeth) through clinical examination.
Change in the SNA angle
时间窗: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.
This angle the represents the position of the upper jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Change in Incisors' positions
时间窗: T0: 1 day before the beginning of retraction. T1: after 1 month (m) of retraction. T2: after 2 m of retraction. T3: after 3 m. T4: after 4 m. T5: at the end of retraction (expected to be within 6 m in the exp. group and 8 m in the control group)
Amount of distance being traveled by the retracted anterior teeth is going to be measured on study models taken at monthly intervals until the end of the retraction phase.
Change in the SNB angle
时间窗: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.
This angle the represents the position of the lower jaw in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Rate of retraction
时间窗: The calculation of the rate of retraction will be done once the retraction procedures has finished. Completion of this procedure is expected to occur within 6 months in the experimental group and 8 months in the control group.
Assessment will be performed on study models. The amount of distance being retracted in millimeters will be divided by the duration of retraction in weeks to give an estimation of the retraction rate.
Change in Molars' positions
时间窗: T0: 1 day before the beginning of retraction. T1: after 1 month (m) of retraction. T2: after 2 m of retraction. T3: after 3 m. T4: after 4 m. T5: at the end of retraction (expected to be within 6 m in the exp. group and 8 m in the control group)
Amount of distance being traveled by the first molars and is going to be measured on study models taken at monthly intervals until the end of the retraction phase.
Change in the ANB angle
时间窗: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.
This angle the represents the spatial relationship between the upper and lower jaws in the cephalometric analysis in the anteroposterior direction. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Change in the SN.GoMe angle
时间窗: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.
This angle the represents the amount of backward rotation of the lower jaw in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
Change in the MM angle
时间窗: The cephalogram will be taken twice, 1 week before the commencement of the retraction and at the completion of retraction. Completion of this procedure is expected to be done within 6 months in the experimental group and 8 months in the control group.
This angle the represents the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis. Lateral cephalograms will be taken and this angle is going to be measured in degrees.
次要结局
- Change in the Bleeding index(This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.)
- Change in the Gingival index(This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.)
- Gingival Recession(Two measurements are required for this calculation: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.)
- Change in the levels of pain and discomfort(Levels of pain will be assessed at : 24 hours following the surgical intervention (T1), one week (T2) , two weeks (T3) and four weeks (T4) following the surgical intervention)
- Change in the Plaque index(This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.)
- Change in Tooth Vitality(This will be measured: one day before the commencement of the retraction phase and at the end of the retraction phase which is expected to occur within 6 months in the experimental group and 8 months in the control group.)