Trial · NCT07897864
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Longitudinal change in mandibular anterior Little's Irregularity Index (LII) | Baseline (T0, before initial appliance placement) and Weeks 4, 8, 12, 16, 20 and 24 after initial appliance placement (APP0). | LII is the sum of five horizontal displacements between corresponding anatomical contact points of adjacent mandibular anterior teeth (43-33), measured in millimeters on digital models. Decreases from baseline indicate improved alignment. |
| Secondary | Alignment Progression and Time to Documented Alignment | Baseline and Weeks 4, 8, 12, 16, 20 and 24 after initial appliance placement. Time to documented alignment: from initial placement up to Week 24. | Mandibular anterior alignment is assessed on digital models using Little's Irregularity Index (LII). Measures include interval LII reduction (mm), improvement rate (mm per four weeks, using actual elapsed intervals), cumulative percentage improvement from baseline, proportion achieving LII ≤1 mm, time (days) from initial appliance placement to the first scan documenting LII ≤1 mm, and area under the LII curve (mm × weeks; trapezoidal rule using scheduled weeks; lower values indicate faster or more complete alignment). |
| Secondary | Changes in mandibular arch dimensions | Baseline and Weeks 4, 8, 12, 16, 20 and 24 after initial placement. | Digital-model changes from baseline (mm) in intercanine cusp-tip width, first-premolar Pont width, first-molar middle-buccal-cusp width and anterior arch depth. Pont points lie at the distal marginal ridge/distal buccal-cusp-slope junctions. Depth is the greatest perpendicular distance from either lower central incisor's most labial incisal-edge point to the first-premolar Pont line. |
| Secondary | Changes in lower incisor inclination and protrusion | Baseline and Week 24 after initial placement, before treatment procedures. | Changes from baseline on lateral cephalograms in the angles between the lower incisor's long axis and the mandibular plane (gonion-menton, Go-Me) and nasion-point B line (NB), measured in degrees, and the perpendicular distance from its most labial crown point to NB, measured in millimeters. |
| Secondary | Mandibular anterior rotation correction | Baseline and Weeks 4, 8, 12, 16, 20 and 24 after initial placement. | Crown-axis angular deviations of the six lower anterior teeth from the digital target setup approved before randomization, measured in the reference occlusal plane. The main indicator is mean absolute error (MAE; degrees); root mean square error (RMSE; degrees) and percentage reduction from baseline MAE are supportive indicators. Lower angular errors indicate closer agreement with the target. |
| Secondary | Mean Silness-Löe Plaque Index Score | Baseline and Weeks 4, 12 and 24 after initial appliance placement, before cleaning or treatment procedures. | Mean Plaque Index score (0-3) across up to 48 sites on mandibular teeth 46-36. The mean is calculated from the sites actually assessed, with the number of assessed sites recorded. Higher scores indicate greater plaque accumulation. |
| Secondary | Mean Löe-Silness Gingival Index Score | Baseline and Weeks 4, 12 and 24 after initial appliance placement, before cleaning or treatment procedures. | Mean Gingival Index score (0-3) across up to 48 sites on mandibular teeth 46-36. The mean is calculated from the sites actually assessed, with the number of assessed sites recorded. Higher scores indicate greater gingival inflammation. |
| Secondary | Mean Papillary Bleeding Index Score | Baseline and Weeks 4, 12 and 24 after initial appliance placement, before cleaning or treatment procedures. | Mean Mühlemann Papillary Bleeding Index score (0-4) across up to 22 buccal and lingual papillary sides in the mandibular region 46-36. The mean is calculated from the papillary sides actually assessed, with the number assessed recorded. Higher scores indicate greater papillary bleeding. |
| Secondary | Number and Percentage of Calculus-Positive Surfaces (Calculus Surface Index) | Baseline and Weeks 4, 12 and 24 after initial appliance placement, before cleaning or treatment procedures. | Number and percentage of calculus-positive surfaces on the four mandibular incisors (42, 41, 31 and 32), assessed on four surfaces per tooth (labial, lingual, mesial and distal). The count ranges from 0 to 16 when all surfaces are assessed; the percentage uses the number of surfaces actually assessed as its denominator. Higher values indicate more calculus. |
| Secondary | Oral health-related quality of life | Baseline and Weeks 4, 8, 12, 16, 20 and 24 after initial placement, before clinical procedures. | Arabic-language Oral Health Impact Profile-14 (OHIP-14), with a total score of 0-56 and a preceding-month recall period; higher scores indicate worse impact. Four separate descriptive indicators-oral function, orofacial pain, orofacial appearance and psychosocial impact-each range from 0-8. |
| Secondary | Psychosocial impact of dental aesthetics | Baseline, Day 7, and Weeks 4, 12 and 24 after initial appliance placement; clinic assessments before treatment procedures. | Arabic Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ-Ar): 23 items, with six dental self-confidence items reverse-scored, yielding a total of 0-92. Higher scores indicate worse psychosocial impact. Assessments characterize changes during treatment, with the appliance present at the final assessment. |
| Secondary | Patient Experience and Satisfaction Assessed by Visual Analogue Scales | Experience: Days 1/7 and Weeks 4/12/24 after initial placement; also 24 h/7 days after the first non-round wire (planned Week 8 for 3D-BOT; Week 12 for control; actual dates used). Satisfaction: Week 24. Clinic ratings precede procedures. | Study-specific 0-100 mm visual analogue scales assess appliance-related symptoms and functional and social impacts over the preceding 24 hours. Appliance-related satisfaction and willingness to choose the same appliance again or recommend it are assessed at Week 24 based on the participant's experience to date. Each item is analyzed separately; no overall score is calculated. Higher symptom and impact scores indicate worse experience, whereas higher satisfaction and willingness scores indicate more favorable responses. |
| Secondary | Pain Intensity, Burden and Interference | Before initial placement/actual activation and 4, 24, 48, 72, 96, 120, 144 and 168 hours later; interference at Day 7. Sessions occur through Week 24. Pain burden: 4-168 hours after each session; cumulative burden: all sessions through Week 24. | Pain intensity is assessed using a 0-10 Numerical Rating Scale (0=no pain; 10=worst imaginable pain). Pain burden is the trapezoidal area under the scheduled pain scores from 4 to 168 hours (score × hours), excluding the pre-procedure reading, calculated for initial placement and for each subsequent session with actual activation. Cumulative pain burden is the sum of these areas for all activation sessions from initial placement through the Week 24 session, including its full 168-hour follow-up; sessions without activation contribute zero. Separate 0-10 ratings assess pain interference with sleep, mood, work/study and social life over the preceding seven days. Higher scores indicate greater pain, burden or interference. |
| Secondary | Analgesic Use, Dose and Time to First Dose | During the 24 hours before and seven days after initial appliance placement and each actual activation through Week 24. | Measures include any analgesic use, number of days of use, number of doses, cumulative dose (mg) for each drug, and time to the first dose after the procedure. Different drugs are recorded and summarized separately. Analgesic use during the preceding 24 hours is recorded separately. |
| Secondary | Clinical procedure, digital preparation time and treatment burden | Planning through completion of Week 24 procedures, including final wire placement. Alignment-target burden ends before treatment at the first qualifying scan documented by Week 24. | The main comparison is cumulative net clinical procedure time (minutes), including initial application, planned procedures and repairs/unplanned interventions, but excluding isolation, interproximal reduction and non-procedural pauses. Initial application, planned-procedure and repair times are also reported separately. Additional 3D-BOT digital setup and wire-planning time is described separately and added to clinical time for a supplementary total; control-group research-only setup is excluded. Cumulative clinical time, unplanned visits, repair counts and repair time are additionally summarized up to the first scan documenting Little's Irregularity Index ≤1 mm, excluding subsequent procedures at that visit. Non-achievement by Week 24 is recorded. |
| Secondary | Clinical appliance failure and failure patterns | Initial appliance placement through the Week 24 assessment, before treatment procedures. | Clinically confirmed unplanned loss of appliance stability or mechanical integrity requiring intervention. Outcomes include the proportion with failure, event counts and days to first failure. Events are classified by type, site, suspected cause, wire stage and same-site recurrence. A fixation unit is a bonded bracket/tube in conventional treatment or a composite fixation point in 3D-BOT. Each failed unit and recurrence after repair counts separately. Unit-related failure rates are expressed as events per fixation-unit-week of exposure. Failure timing is classified relative to the most recent placement or rebonding of the affected unit: immediate (0-24 hours), early (\>24 hours to four weeks), or late (\>four weeks). Time to the participant's first failure is measured from initial appliance placement and does not reset after repair or wire replacement. |
| Secondary | Incidence and Severity of New Oral Mucosal Lesions | Baseline; Days 1 and 7; Weeks 4, 8, 12, 16, 20 and 24 after initial placement, plus interim monitoring. Follow-up ends before Week 24 treatment procedures. | Proportion developing new lesions, new-lesion count, maximum clinically assessed severity on a study-specific 0-4 scale (0=no lesion; 4=severe ulceration, marked speech/chewing difficulty or medication requirement), maximum diameter (mm), speech/chewing effects, medication need and percentage of scheduled assessments with lesions. Pre-existing lesions are recorded separately; persistent lesions count once and recurrence after resolution counts as new. |
| Secondary | External root resorption of mandibular anterior teeth | Baseline and Week 24 after initial appliance placement. | Root shortening of the six mandibular anterior teeth, calculated as baseline root length minus Week 24 root length (mm) on paired cone-beam computed tomography images. Results are summarized per tooth and as the participant-level mean across evaluable teeth; the number of teeth assessed is recorded. |
| Secondary | Changes in mandibular anterior alveolar bone | Baseline and Week 24 after initial appliance placement. | Changes from baseline in buccal, lingual and interradicular bone thickness and alveolar crest level (mm) around the six mandibular anterior teeth, assessed using cone-beam computed tomography, together with the number and proportion of assessable sites showing radiographic dehiscence or fenestration. Non-assessable sites are documented. |
| Other | Short-term oral health-related quality of life | Baseline and seven days after initial appliance placement and the Week 4, 8, 12, 16, 20 and 24 visits. | Arabic five-item Oral Health Impact Profile (OHIP5-Ar), with seven-day recall and a total score of 0-20. Higher scores indicate worse oral health-related quality of life. Total scores and changes from baseline are assessed regardless of whether the preceding visit included activation. |
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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