This 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, oral health-related quality of life, pain and anxiety levels, and speech function. 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.
This 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, oral health-related quality of life, pain and anxiety levels, and speech function. 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. Detailed Description 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. Appliance-related changes in intraoral volume and tongue movement can 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. This prospective study was designed to investigate how clear aligners and removable appliances influence oral hygiene status, pain and anxiety perception, oral health-related quality of life, and speech performance in children. Through standardized clinical assessments, validated questionnaires, and acoustic analysis, the study aims to generate multidimensional data that may guide clinical decision-making in early orthodontic treatment planning.
Study Type
OBSERVATIONAL
Enrollment
24
Marmara Universty School of Dentistry
Istanbul, Maltepe, Turkey (Türkiye)
Formant frequencies (F1-F4) during speech production
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.
Time frame: At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.
Voice Onset Time (VOT)
Assessment of speech timing by measuring Voice Onset Time (VOT) from standardized speech recordings collected immediately before appliance placement and on days 1, 3, 7, and 14 after insertion. Selected words containing voiceless and voiced stop consonants were read aloud by participants, and VOT values were extracted using Praat software to evaluate treatment-related changes in articulatory timing. Units: Milliseconds (ms) Range: Approximately -100 ms to +150 ms (dependent on consonant type and participant characteristics) Higher values indicate: Longer delays between consonant release and onset of voicing, reflecting increased articulatory timing.
Time frame: At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.
Spectral Centre of Gravity (CoG)
Assessment of spectral energy distribution during speech production by measuring the spectral Centre of Gravity (CoG) from standardized speech recordings. Recordings were obtained immediately before appliance placement and on days 1, 3, 7, and 14 after insertion. Selected words containing target consonants and vowels were read aloud by participants, and CoG values were extracted using Praat software to evaluate treatment-related changes in spectral balance and resonance characteristics. Units:Hertz (Hz) Range: Approximately 500-6000 Hz (dependent on sound type and participant characteristics) Higher values indicate: Spectral energy concentrated at higher frequencies, reflecting changes in resonance or articulatory configuration.
Time frame: At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.
Spectral skewness
Assessment of spectral shape during speech production by measuring spectral skewness from standardized speech recordings. Recordings were obtained immediately before appliance placement and on days 1, 3, 7, and 14 after insertion. Selected words containing target consonants and vowels were read aloud by participants, and skewness values were extracted using Praat software to evaluate treatment-related changes in the asymmetry of the spectral energy distribution. Units: Dimensionless (no unit) Range: Approximately -3.0 to +3.0 (dependent on sound type and participant characteristics) Higher values indicate: Greater positive asymmetry of the spectral energy distribution (more energy concentrated above the mean frequency).
Time frame: At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.
Spectral kurtosis
Assessment of spectral shape during speech production by measuring spectral kurtosis from standardized speech recordings. Recordings were obtained immediately before appliance placement and on days 1, 3, 7, and 14 after insertion. Selected words containing target consonants and vowels were read aloud by participants, and kurtosis values were extracted using Praat software to evaluate treatment-related changes in the peakedness of the spectral energy distribution. Units: Dimensionless (no unit) Range: Approximately -1.0 to +10.0 (dependent on sound type and participant characteristics) Higher values indicate: A more peaked spectral energy distribution with relatively more energy concentrated around the mean frequency.
Time frame: At baseline (before treatment) and on the 1st, 3rd, 7th, and 14th days of treatment.
Plaque Index (PI; Silness & Löe)
Assessment of dental plaque accumulation recorded at baseline, Day 1, and Day 14. Units: Score (0-3) Higher values indicate worse plaque accumulation.
Time frame: At baseline (before treatment) and 14th days of treatment.
Gingival Index (GI; Löe & Silness)
Evaluation of gingival inflammation recorded at baseline, Day 1, and Day 14. Units: Score (0-3) Higher values indicate worse gingival inflammation.
Time frame: At baseline (before treatment) and 14th days of treatment.
Pain perception (Visual Analog Scale)
Pain perception during early orthodontic treatment will be evaluated using a Visual Analog Scale (VAS). Participants will be asked to rate their pain on a 0-10 scale at multiple time points during adaptation to the appliance, including Days 1, 3, 7, and 14 following appliance insertion. Units: Scale score (0-10) Range: 0 (no pain) to 10 (severe pain) Higher values indicate: Greater perceived pain intensity.
Time frame: 1st, 3rd, 7th, and 14th days of treatment
Anxiety levels during treatment (State-Trait Anxiety Inventory for Children)
Anxiety levels during early orthodontic treatment will be evaluated using the State-Trait Anxiety Inventory for Children (STAI-C). Participants will complete the inventory on Days 1, 3, 7, and 14 following appliance insertion to assess treatment-related anxiety at multiple time points. Units: Scale score (20-60) Range: 20 (low anxiety) to 60 (high anxiety) Higher values indicate: Greater anxiety levels.
Time frame: 1st, 3rd, 7th, and 14th days of treatment
Oral health-related quality of life during treatment (OHIP-14)
Oral health-related quality of life during early orthodontic treatment will be evaluated using the Oral Health Impact Profile-14 (OHIP-14). Participants will complete the OHIP-14 questionnaire on Days 1, 3, 7, and 14 following appliance insertion to assess treatment-related changes in patient-reported oral health impact. Units: Scale score (0-56) Range: 0 (better oral health-related quality of life) to 56 (worse oral health-related quality of life) Higher values indicate: Worse oral health-related quality of life.
Time frame: 1st, 3rd, 7th, and 14th days of treatment
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