Targeting the Premaxillary-Maxillary Suture for Skeletal Class III Correction in Growing Patients: Ertty Gap III Versus Facemask Therapy in a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in ANB Angle
研究概览
简要总结
This single-center, parallel-group randomized clinical trial compared 2 orthopedic treatment approaches in growing patients with skeletal Class III malocclusion associated predominantly with maxillary deficiency: the Ertty Gap III appliance and facemask therapy. Forty-two participants were randomly allocated in a 1:1 ratio to Ertty Gap III or facemask therapy. The primary objective was to compare the short-term skeletal effects of the 2 treatment protocols, with the ANB angle designated as the primary outcome. Skeletal, dentoalveolar, and soft-tissue outcomes were assessed using standardized lateral cephalometric radiographs obtained before treatment and at treatment completion.
详细描述
Skeletal Class III malocclusion in growing patients may be associated with maxillary deficiency, mandibular prognathism, or a combination of both. Early orthopedic treatment directed toward maxillary advancement is commonly performed using facemask therapy. The Ertty Gap III appliance is an intraoral orthopedic appliance designed to apply Class III corrective forces through a different biomechanical configuration.
This prospective, single-center, parallel-group randomized clinical trial compared the short-term skeletal, dentoalveolar, and soft-tissue effects of the Ertty Gap III appliance with those of facemask therapy in growing patients with skeletal Class III malocclusion associated predominantly with maxillary deficiency. Forty-two eligible participants were randomly allocated in a 1:1 ratio to the Ertty Gap III or facemask group using concealed allocation.
Standardized lateral cephalometric radiographs were obtained before treatment (T0) and at completion of active orthopedic treatment (T1). The ANB angle was designated as the primary outcome. The between-treatment effect for ANB was evaluated by comparing posttreatment values between the groups after adjustment for the corresponding pretreatment value. Secondary and supportive exploratory outcomes included selected skeletal, dentoalveolar, occlusal, and soft-tissue cephalometric measurements.
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
- None
盲法说明
Because of the nature of the interventions, participants and the treating investigator could not be blinded to treatment allocation. Cephalometric measurements were performed by the treating investigator who delivered the treatments; therefore, the outcome assessor was not blinded. The statistician was blinded to treatment allocation, with the 2 study groups coded as A and B during the statistical analyses.
入排标准
- 年龄范围
- 9 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 9 and 12 years.
- •Late mixed or early permanent dentition.
- •Skeletal Class III malocclusion characterized by an A point-Nasion-B point (ANB) angle ≤ 0° and a Class III molar relationship.
- •Maxillary deficiency confirmed by clinical and cephalometric assessment, including evaluation of the Sella-Nasion-Point A (SNA) angle according to Steiner analysis (82° ± 2° as the reference) and clinical evidence of perinasal or midfacial deficiency.
- •In participants with associated mandibular prognathism, maxillary retrognathia was required to be the predominant skeletal component of the Class III discrepancy.
- •Anterior crossbite or an edge-to-edge incisal relationship.
- •No previous orthodontic or orthopedic treatment.
排除标准
- •Completed skeletal growth.
- •Skeletal Class III malocclusion attributable solely to mandibular prognathism without clinical or cephalometric evidence of maxillary retrognathia.
- •Presence of systemic disease.
- •Craniofacial syndromes or congenital craniofacial anomalies.
- •Temporomandibular joint disorders.
- •Congenital absence of maxillary lateral incisors.
- •Palatally displaced permanent canines.
- •Missing, extracted, or prematurely lost permanent first molars.
研究组 & 干预措施
Ertty Gap III Group
Participants assigned to this arm received orthopedic treatment with the Ertty Gap III appliance. The treatment protocol involved maxillary protraction using an intraoral appliance designed to apply orthopedic forces to the maxillary complex. Treatment was continued until correction of the anterior crossbite and achievement of a positive overjet.
干预措施: Ertty Gap III Appliance (Device)
Facemask Group
Participants assigned to this arm received conventional orthopedic maxillary protraction with facemask therapy. Treatment was continued until correction of the anterior crossbite and achievement of a positive overjet.
干预措施: Facemask Therapy (Device)
结局指标
主要结局
Change in ANB Angle
时间窗: Baseline to completion of orthopedic treatment (approximately 13 months; treatment continued until achievement of a positive overjet)
Change in the ANB angle (degrees) from baseline to completion of orthopedic treatment, assessed on standardized lateral cephalometric radiographs. The ANB angle represents the sagittal skeletal relationship between the maxilla and mandible. A positive change indicates improvement in the sagittal maxillomandibular relationship.
次要结局
- Change in Sella-Nasion-Point A Angle (SNA)(Baseline to completion of orthopedic treatment or the corresponding observation period (approximately 13 months))
- Change in Sella-Nasion-Point B Angle (SNB)(Baseline to completion of orthopedic treatment or the corresponding observation period (approximately 13 months))
- Change in Wits Appraisal(Baseline to completion of orthopedic treatment or the corresponding observation period (approximately 13 months).)
- Change in Point A to Nasion Perpendicular Distance(Baseline to completion of orthopedic treatment or the corresponding observation period (approximately 13 months).)
- Change in Pogonion to Nasion Perpendicular Distance(Baseline to completion of orthopedic treatment or the corresponding observation period (approximately 13 months).)
- Change in Condylion-to-Point A Distance (Co-A)(Baseline to completion of orthopedic treatment or the corresponding observation period (approximately 13 months).)
- Change in Condylion-to-Gnathion Distance (Co-Gn)(Baseline to completion of orthopedic treatment or the corresponding observation period (approximately 13 months).)
- Change in Gonion-Gnathion/Sella-Nasion Angle (GoGn/SN)(Baseline to completion of orthopedic treatment or the corresponding observation period (approximately 13 months).)
- Change in Frankfort Horizontal-Mandibular Plane Angle (FH-MP)(Baseline to completion of orthopedic treatment or the corresponding observation period (approximately 13 months).)
- Change in Anterior Nasal Spine-to-Menton Distance (ANS-Me)(Baseline to completion of orthopedic treatment or the corresponding observation period (approximately 13 months).)
- Change in Sella-to-Gonion Distance (S-Go)(Baseline to completion of orthopedic treatment or the corresponding observation period (approximately 13 months).)
- Change in Maxillary Incisor to Nasion-Point A Linear Distance (U1-NA)(Baseline to completion of orthopedic treatment or the corresponding observation period (approximately 13 months).)
- Change in Maxillary Incisor to Nasion-Point A Angle (U1-NA)(Baseline to completion of orthopedic treatment or the corresponding observation period (approximately 13 months).)
- Change in Maxillary Incisor-to-Palatal Plane Angle (U1-PP)(Baseline to completion of orthopedic treatment or the corresponding observation period (approximately 13 months).)
- Change in Incisor Mandibular Plane Angle (IMPA)(Baseline to completion of orthopedic treatment or the corresponding observation period (approximately 13 months).)
- Change in Mandibular Incisor to Nasion-Point B Linear Distance (L1-NB)(Baseline to completion of orthopedic treatment or the corresponding observation period (approximately 13 months).)
- Change in Mandibular Incisor to Nasion-Point B Angle (L1-NB)(Baseline to completion of orthopedic treatment or the corresponding observation period (approximately 13 months).)
- Change in Overjet(Baseline to completion of orthopedic treatment or the corresponding observation period (approximately 13 months).)
- Change in Overbite(Baseline to completion of orthopedic treatment or the corresponding observation period (approximately 13 months).)
- Change in Maxillary First Molar-to-Palatal Plane Distance (U6t-PP)(Baseline to completion of orthopedic treatment or the corresponding observation period (approximately 13 months).)
- Change in Maxillary First Molar-to-Pterygoid Vertical Distance (U6d-PTV)(Baseline to completion of orthopedic treatment or the corresponding observation period (approximately 13 months).)
- Change in Upper Lip Position Relative to Steiner's S-line (UL-S)(Baseline to completion of orthopedic treatment or the corresponding observation period (approximately 13 months).)
- Change in Lower Lip Position Relative to Steiner's S-line (LL-S)(Baseline to completion of orthopedic treatment or the corresponding observation period (approximately 13 months).)
- Change in Nasolabial Angle(Baseline to completion of orthopedic treatment or the corresponding observation period (approximately 13 months).)
研究者
Hilal Algul
Research Assistant
Ankara University