A Comparative Evaluation of Removable Appliances and Clear Aligners in Terms of Multidimensional Parameters and Their Effects on Phonation in Early Orthodontic Treatments During the Mixed Dentition Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Formant frequencies (F1-F4) during speech production
研究概览
简要总结
This prospective study aims to compare two different orthodontic treatment modalities-clear aligners and removable appliances-in children aged 6 to 12 years during the mixed dentition period. The primary focus of the research is to evaluate treatment-related changes in oral hygiene status assessed using the Simplified Oral Hygiene Index (OHI-S), oral health-related quality of life, pain and anxiety levels, and speech function. In addition, orthodontic treatment need will be assessed using the Index of Orthodontic Treatment Need (IOTN), including both the Dental Health Component (DHC) and Aesthetic Component (AC). By assessing multiple dimensions associated with early orthodontic intervention, the study seeks to provide a comprehensive understanding of how different appliance types influence clinical, functional, and psychosocial outcomes in pediatric patients.
详细描述
This prospective study aims to compare two different orthodontic treatment modalities-clear aligners and removable appliances-in children aged 6 to 12 years during the mixed dentition period. The primary focus of the research is to evaluate treatment-related changes in oral hygiene status assessed using the Simplified Oral Hygiene Index (OHI-S), oral health-related quality of life, pain and anxiety levels, and speech function. In addition, orthodontic treatment need will be assessed using the Index of Orthodontic Treatment Need (IOTN), including both the Dental Health Component (DHC) and Aesthetic Component (AC). By assessing multiple dimensions associated with early orthodontic intervention, the study seeks to provide a comprehensive understanding of how different appliance types influence clinical, functional, and psychosocial outcomes in pediatric patients.
The mixed dentition period, occurring approximately between the ages of 6 and 12, represents a transitional developmental stage during which primary and permanent teeth coexist. In this phase, early diagnosis and treatment of orthodontic anomalies are particularly important to support functional, aesthetic, and psychosocial development and to minimize the need for more complex treatment in later stages.
Removable orthodontic appliances have traditionally been used to guide dental arch development, correct minor malocclusions, and eliminate harmful oral habits. Advances in digital technology have introduced clear aligners as an alternative treatment option that offers aesthetic and removable features. Despite their differences in design and material characteristics, both approaches are commonly used during early orthodontic treatment planning.
Orthodontic appliances may influence various aspects of oral function, including oral hygiene maintenance, periodontal health, caries risk, pain perception, anxiety levels, and speech performance. In growing children, treatment experiences may additionally shape cooperation, adaptation, and overall quality of life. Therefore, evaluating orthodontic interventions during the mixed dentition period requires consideration of not only mechanical efficiency but also broader functional and psychosocial parameters.
Orthodontic treatment need and malocclusion severity may also influence oral hygiene maintenance during treatment. Therefore, the present study additionally evaluates the relationship between orthodontic treatment need assessed using the IOTN and oral hygiene status assessed using the OHI-S at baseline and during the early treatment period. Appliance-related changes in intraoral volume and tongue movement may alter speech production, potentially affecting articulatory patterns and acoustic characteristics. Contemporary acoustic analysis methods, such as the use of specialized speech software, allow the objective measurement of frequency- and time-based acoustic parameters and provide complementary information to clinical observations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 12 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Children aged between 6 and 12 years who applied to the Clinics of the Departments of Pedodontics and Orthodontics at Marmara University Faculty of Dentistry were included in the study.
- •Patients were required to present with anterior cross-bite type malocclusion.
- •Participants had to be cooperative, native Turkish speakers, and have no systemic disease, syndrome, craniofacial anomaly, or known allergy.
- •Individuals with no apparent oro-facial anomaly, no hearing or speech impairment, and no reading or language difficulties were included.
- •Based on clinical and radiographic evaluations, only patients whose malocclusions were determined to be dental in origin (not skeletal) were selected.
- •Patients who did not require maxillary (palatal) expansion were also included in the study.
排除标准
- •The study excluded patients who had severe periodontal disease, a history of systemic illness, a known allergy to any of the materials used in the study, poor oral hygiene, insufficient cooperation, or who did not agree to attend regular follow-up appointments during the study period.
- •Additionally, individuals with craniofacial anomalies or skeletal-origin malocclusions were not included. Participants with hearing impairments, non-native Turkish speakers, or those with any disease or history of surgery that could affect voice or speech quality were also excluded from the study.
研究组 & 干预措施
Patients treated with removable orthodontic appliances
Patients aged between 6 and 12 years who required early orthodontic treatment and started removable orthodontic appliance therapy were included in the study.
Patients treated with clear aligners
Patients aged between 6 and 12 years who required early orthodontic treatment and started clear aligner therapy were included in the study.
结局指标
主要结局
Formant frequencies (F1-F4) during speech production
时间窗: At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.
Evaluation of phonation changes during early orthodontic treatment by analysing the first four formant frequencies (F1-F4) obtained from standardized speech recordings. Recordings were collected immediately before appliance placement and on days 1, 3, 7, and 14 after appliance insertion. Words selected from a standardized articulation test were read aloud by the participants, and acoustic data were analysed using Praat software to assess treatment-related variations in vowel resonance patterns. Units: Hertz (Hz) Higher values indicate: Changes in vowel resonance characteristics potentially related to treatment-related alterations in oral cavity configuration.
次要结局
- Simplified Oral Hygiene Index (OHI-S)(At baseline (before treatment) and Day 14 of treatment.)
- Index of Orthodontic Treatment Need (IOTN)(At baseline (before treatment).)
- Voice Onset Time (VOT)(At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.)
- Spectral Centre of Gravity (CoG)(At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.)
- Spectral skewness(At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.)
- Plaque Index (PI; Silness & Löe)(At baseline (before treatment) and 14th days of treatment.)
- Gingival Index (GI; Löe & Silness)(At baseline (before treatment) and 14th days of treatment.)
- Pain perception (Visual Analog Scale)(1st, 3rd, 7th, and 14th days of treatment)
- Spectral kurtosis(At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.)
- Anxiety levels during treatment (State-Trait Anxiety Inventory for Children)(1st, 3rd, 7th, and 14th days of treatment)
- Oral health-related quality of life during treatment (OHIP-14)(1st, 3rd, 7th, and 14th days of treatment)
研究者
Neslihan Atmaca
Principal Investigator
Marmara University
