Clinical trial NCT04875104: Upper Sequential Distalization With TADs and Aligners
Official title: A Randomized Clinical Trial on Upper Sequential Distalization With Temporary Anchorage Devices (TADs) and Two Aligner Systems
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Malocclusion, Angle Class II
Distalization
Keywords: Dentistry
Orthodontics
Clear aligner therapy
Aligners
Invisalign
Upper molar distalization
Temporary anchorage devices
Mini-screws
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 392
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be a 4-arm parallel-group, randomized, prospective superiority clinical trial with an allocation ratio of 1:1:1:1 There will be four groups of aligners of different brands.
Primary purpose: TREATMENT

Brief summary: In this study the investigators are going to compare the predictability of the backward movement of upper first molars in patients with the upper dentition more advanced than the lower dentition. The investigators are going to study if the movements that they predict are achieved and in which proportion and compare it between four different aligner systems. The investigators hypothesis is that there are no differences in the predictability of this movement between the four aligner systems.

Detailed description: In this study the investigators are going to assess and compare the predictability of distal movement of upper molars in patients with class II molar relationship when superimposing the initial malocclusion with the real end of distalization phase and the predicted end of distalization phase. Also, the investigators are going to study another dental movements, pain level, aligner properties, oral hygiene, posterior root resorption, patient satisfaction, quality of life and efficiency of these systems.

The aligner systems that are going to be used are Invisalign System (Align Technology, San José, CA), Spark Aligners (Ormco, Glendora, CA), Quicksmile (Madrid, España) and ClearCorrect (Straumann, Austin, TX). To help achieve the molar movement there is going to be place a TAD (temporary anchorage device) between two teeth. Before starting the study, the patients will need some pretreatment records (radiographs, photographs, dental casts and intraoral scan) to make a diagnosis and confirm if the patient is suitable for the study.

The required sample will be 98 subjects, assuming a sample loss of 15% the required sample will be 115 subjects per group. Patients will be randomly assigned to either group using a block randomization system and carried out by a researcher not involved in the study. Data normality will be examined with the Kolmogorov-Smirnov. Descriptive statistics of the different outcomes will be calculated for each group. Student's paired sample t-test will be used to analyze intragroup differences between T0 and T1. Intergroup comparison among different intervention groups will be performed using multiple analysis of variance (MANOVA), with Tukey's post-hoc test. The investigators will use the Pearson correlation coefficient to evaluate the linear relationship between the mm of distalization achieved and the mm of crowding and between the mm of distalization achieved and the patients age. The investigators will perform a binary logistic regression in order to assess the influence of confounding factor (clinical variables) on the primary outcome. All statistical analysis will be conducted using IBM SPSS 24.0 (SPSS Inc., Chicago, IL, USA) software with a 0.05 level of significance.

Eligibility criteria: Inclusion Criteria:

* Patients who needed orthodontic treatment with aligners in both jaws.
* Adult patients (\>18 years)
* Full permanent dentition (excluding third molars)
* Patients with non-surgical or non-extraction (excluding third molars) treatment
* No active periodontal disease
* Patients with class II molar relationship that needed molar distalization

Exclusion Criteria:

* Patients with systemic diseases affecting bone metabolism or teeth or inflammatory diseases
* Patients undergoing treatment with immunosuppressant or bisphosphonates
* Patients undergoing chemo and radiotherapy
* Patients with any other syndrome-associated orofacial deformation, cleft lip or palate
* Pregnant women or non(or poor)-compliance patients with skeletal discrepancies
* Patients with dental or skeletal crossbite that need 3 mm or more per side of expansion

Primary outcomes:
measure: Predictability of upper molar distalization
timeFrame: Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months)
measure: Achievement of molar class I
timeFrame: Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months)
Secondary outcomes:
measure: Individual tooth movement
timeFrame: Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months)
measure: Periodontal mucosa health status - Plaque Index (PI)
timeFrame: Time 0 (initial day of treatment), month 3 and month 6
measure: Periodontal mucosa health status - Gingival Index (GI)
timeFrame: Time 0 (initial day of treatment), month 3 and month 6
measure: Periodontal mucosa health status - Papillary Bleeding Index (PBI)
timeFrame: Time 0 (initial day of treatment), month 3 and month 6
measure: Peri-implant mucosa inflammation
timeFrame: Time 0 (initial day of treatment), month 3 and month 6
measure: TADs stability
timeFrame: Time 0 (initial day of treatment), month 3 and month 6
measure: Quantification of the modulus of elasticity
timeFrame: Time 0 (initial day of treatment) and week 2
measure: Quantification of changes in force after 75 desinsertion cycles
timeFrame: Time 0 (initial day of treatment) and week 2
measure: Quantification of changes in desinsertion time after 75 desinsertion cycles
timeFrame: Time 0 (initial day of treatment) and week 2
measure: Quantification of changes in deformation after 75 desinsertion cycles
timeFrame: Time 0 (initial day of treatment) and week 2
measure: Quantification of the aligner fit on the attachments
timeFrame: Time 0 (initial day of treatment) and week 2
measure: Orthodontically induced external apical root resorption (OIEARR)
timeFrame: Time 0 (initial day of treatment) and month 6
measure: Quantification of pain level
timeFrame: Week 3, week 7 and week 11.
measure: Quantification of quality of life (OHIP-14sp)
timeFrame: Time 0 (initial day of treatment) and month 1
measure: Quantification of patient satisfaction (DSQ)
timeFrame: Time 0 (initial day of treatment) and month 1
measure: Quantification of the treatment and chair time.
timeFrame: Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months)
measure: Quantification of the number of appointments.
timeFrame: Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months)
measure: Quantification of the direct and indirect costs.
timeFrame: Time 0 (initial day of treatment) to Time 1 (achievement of class I, 10-12 months)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Universidad Complutense de Madrid
Study officials:
affiliation: Universidad Complutense de Madrid
name: Alejandro Iglesias Linares
role: STUDY_DIRECTOR
References: