Trial · NCT07911176
Registered outcomes20
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Final Peer Assessment Rating (PAR) | Baseline, 14 years of age, 16 years of age, and 18 years of age (through study completion). | The primary analysis will compare the three randomized treatment strategies with respect to the final PAR score at 18 years of age, adjusted for baseline PAR score, according to the prespecified statistical analysis plan. PAR scores will be assessed on digital study models. |
| Secondary | Spontaneous alignment of crowded teeth | Baseline, 14 years of age, 16 years of age, and 18 years of age (through study completion). | Dental alignment assessed on digital study models using tooth size arch length discrepency (TSALD, mm) and Little's Irregularity Index (LII, mm) |
| Secondary | Spontaneus extraction space closure | Baseline, 14 years of age, 16 years of age, and 18 years of age (through study completion). | Space closure closure assessed on digital study models using extent of space closure (mm). |
| Secondary | Sagittal skeletal relationship assessed by ANB Angle | Baseline, 14 years of age, 16 years of age, and 18 years of age (through study completion). | Sagittal skeletal relationship asessed using ANB angle (degrees) on lateral cephalometric radiographs. |
| Secondary | Sagittal skeletal relationship assessed by Wits appraisal | Baseline, 14 years of age, 16 years of age, and 18 years of age (through study completion). | Sagittal skeletal relationship asessed using Wits appraisal (mm) on lateral cephalometric radiographs. |
| Secondary | Change in jaw inclination (ML/NSL Angle) | Baseline, 14 years of age, 16 years of age, and 18 years of age (through study completion). | Vertical skeletal relationship asessed using jaw the ML/NSL angle (degrees) on lateral cephalometric radiographs. |
| Secondary | Facial height changes | Baseline, 14 years of age, 16 years of age, and 18 years of age (through study completion). | Vertical skeletal relationship asessed using facial height (mm) measurements on lateral cephalometric radiographs. |
| Secondary | Nasolabial angle changes | Baseline, 14 years of age, 16 years of age, and 18 years of age (through study completion). | Soft-tissue relationships assessed using nasolabial angle (degrees) anon lateral cephalometric radiographs and profile photographs. |
| Secondary | Lip positions relative to Rickett's estethic line | Baseline, 14 years of age, 16 years of age, and 18 years of age (through study completion). | Soft-tissue relationships assessed as the distance from the upper and lower lips to Ricketts' estethic line (mm) on lateral cephalometric radiographs and profile photographs. |
| Secondary | Tooth inclination changes on cephalometric radiographs | Baseline, 14 years of age, 16 years of age, and 18 years of age (through study completion). | Tooth inclination assessed on lateral cephalometric radiographs using anagular measurments (degrees). |
| Secondary | Tooth movements on cephalometric radiographs | Baseline, 14 years of age, 16 years of age, and 18 years of age (through study completion). | Tooth movements assessed on lateral cephalometric radiographs using linear measurments (mm). |
| Secondary | Change in objective treatment need assessed using the Index of Orthodontic Treatment Need (IOTN). | Baseline, 14 years of age, 16 years of age, and 18 years of age (through study completion). | Orthodontic treatment need assessed using the Index of Orthodontic Treatment Need (IOTN). The scale ranges from Grade 1 (no treatment need) to Grade 5 (very great treatment need) with higher scores indicating greater orthodontic treatment need. |
| Secondary | Change in objective treatment need assessed using the Index of Complexity, Outcome and Need (ICON). | Baseline, 14 years of age, 16 years of age, and 18 years of age (through study completion). | Orthodontic treatment need assessed using the Index of Complexity, Outcome and Need (ICON). The scale ranges from \< 29 (easy) to \> 77 (very difficult), with higher scores indicating greater orthodontic treatment need and treatment complexity. |
| Secondary | Change in objective treatment need assessed using the Dental Aesthetic Index (DAI | Baseline, 14 years of age, 16 years of age, and 18 years of age (through study completion). | Orthodontic treatment need assessed using the Dental Aesthetic Index (DAI). The scale ranges from ≤ 25 (no or slight treatment need) to ≥ 36 (treatment mandatory), with higher scores indicating greater orthodontic treatment need and treatment complexity. |
| Secondary | Oral health-related quality of life (OHRQoL) | Baseline, Post-extraction (9-12 years of age), 14 years of age, 16 years of age, and 18 years of age (through study completion). | Oral health-related quality of life assessed using the Child Perceptions Questionnaire (CPQ11-14) Short Form. The scale ranges from 0 to 64, with higher scores indicating a greater negative impact on oral health-related quality of life. |
| Secondary | Self perceived orofacial aesthetics | Baseline, Post-extraction (9-12 years of age), 14 years of age, 16 years of age, and 18 years of age (through study completion). | Orofacial aesthetics assessed using the Orofacial Estethic Scale (OES). The scale ranges from 0 to 70, with higher scores indicating greater satisfaction with orofacial appearence. |
| Secondary | Health economic impact | From baseline to the end of active orthodontic treatment (approximately 16 years of age). | Health economic impact assessed based on treatment duration, chair time, number of visits, healthcare resource utilization, and patient and family costs. |
| Other | Change in white spot lesions | 14 years of age, 16 years of age, and 18 years of age (through study completion). | Changes in number of white spot lesions (early caries lesions) assessed on clinical photographs. |
| Other | Change in DeFS (Decayed, enamel included and Filled Tooth Surfaces) | 14 years of age, 16 years of age, and 18 years of age (through study completion). | Initial and manifest caries lesions assessed on bitewing radiographs using the DeFS index. Higher scores indicate greater caries experience. |
| Other | Change in root length | Baseline, 14 years of age, 16 years of age, and 18 years of age (through study completion). | Extent of root resorptions assessed as change in root length (mm)on panoramic radiographs and periapical radiographs using linear measurements (mm). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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