Trial · NCT07897864
Three-Dimensional Bracketless Orthodontic Treatment (3D-BOT) Using E-WIRE Versus Conventional Fixed Braces for Mild-to-Moderate Lower Front Tooth Crowding in Adults
NCT07897864, Not applicable, Not yet recruiting, University of Aleppo
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Three-Dimensional Bracketless Orthodontic Treatment (3D-BOT) Using E-WIRE Versus Conventional Fixed Braces for Mild-to-Moderate Lower Front Tooth Crowding in Adults. Trials, record NCT07897864. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07897864
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Three-Dimensional Bracketless Orthodontic Treatment (3D-BOT) Using E-WIRE Versus Conventional Fixed Braces for Mild-to-Moderate Lower Front Tooth Crowding in Adults
- NCT number
- NCT07897864
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 40 participants, estimated
- Lead sponsor
- University of Aleppo
- Conditions
- Mild-to-Moderate Mandibular Anterior Crowding
- Interventions
- Conventional Labial Fixed Orthodontic Appliance, 3D-BOT Using E-WIRE Archwires
- First posted
- 2026-10-27
- Last updated
- 2026-11-12
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers10
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07897864
GET https://conductscience.org/api/trials/v1/NCT07897864/registered?page=2