Interceptive Maxillary Expansion to Relief Anterior Crowding in the Mixed Dentition

NCT06187337 | Recruiting

• 1 other identifier: 275470
• Study Type: interventional
• Target: 60
• Locations: 2 countries
• Sites: 4

Brief Summary

The goal of this clinical trial is to compare if it is better to treat severe anterior crowding in the early mixed dentition then later in the permanent dentition in children with anterior crowding of the upper teeth. The main questions this trial aims to answer are:

• If there is a difference in the degree of anterior crowding between the experimental group and the control group after a five year follow-up period.
• If there is a difference between the experimental group and the control group in regard to oral health related quality of life.
• If there is spontaneous transversal adaption of the lower dental arch to upper dental arch after maxillary expansion and compare this to the control group.
• If early maxillary expansion is more cost-effective than treatment in the permanent dentition. To be eligible for this trial the subject must be children between six and nine years old at the time for inclusion. The children must have crowding of the upper front teeth of six millimeters or more and the lateral incisors should not have erupted or just erupted through the gingiva. Subjects randomized to the experimental group will get an expansion treatment in the upper jaw with rapid maxillary expansion device to gain enough space for the lateral incisors to erupt. All subjects, also the subjects randomized to the control group, are followed until all permanent teeth have erupted. At the end of the follow-up period all subjects fill out a questionnaire to evaluate their oral health related quality of life. Researchers will then compare the subjects in both groups to evaluate if there is a difference in anterior crowding after the follow-up period. Differences in cost-effectiveness, morphological changes and the subjects oral health related quality of life will also be evaluated.

Conditions

Crowding of Anterior Maxillary Teeth; Orthodontics, Interceptive; Orthodontics, Corrective, Palatal Expansion Technique

Outcome Measures

Primary Outcomes (1)

• Long-term spontaneous alignment of anterior maxillary teeth

  The long-term spontaneous alignment of anterior maxillary teeth will be evaluated visually and measure on the digital study models.

  At the end of the observation period, an average of 5 years

Secondary Outcomes (4)

• Impact on oral health related quality of life

  At the end of the observation period, an average of 5 years.

• Cost-effectiveness of early expansion treatment

  At the end of the observation period, an average of 5 years.

• Morphological changes in the upper and lower arches.

  At the end of the observation period, an average of 5 years.

• Complications of expansion.

  At the end of the observation period, an average of 5 years.

Study Arms (2)

Early maxillary expansion

EXPERIMENTAL

The subjects in the experimental group will be treated with a maxillary expansion appliance with bands on the second deciduous molars and arms to the deciduous canines. The screw gives a expansion of 0,20 millimeter per activation. The arms are bonded to the deciduous canines with light curing composite and the bands are cemented with glassionomer cement. The subject are instructed to activate the appliance once a day (1/4 turn) for 2 weeks and thereafter every second day until adequate space for the lateral incisors is obtained.During the expansion the subjects will be asked to complete a questionnaire on pain and discomfort. The subjects will be recalled for follow-up visits after 24 months (T1), 36 months (T2), 48 months (T3) and when all permanent premolars are erupted (T4). At T1, T2 and T4 the subjects are asked to fill out the Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ). The subjects need for further treatment will be evaluated and initiated at T4.

Device: Maxillary expansion device

Control group

NO INTERVENTION

The control group is not going to receive any treatment under the observation period. The subjects will be recalled for follow-up visits with photographs (4 extraoral photos and 5 intraoral photos) and study models (digital or cast) after 24 months (T1), 36 months (T2), 48 months (T3) and when all permanent premolars are erupted (T4). At T1, T2 and T4 the subjects are asked to fill out the Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) to evaluate their oral health related quality of life. The subjects need for further treatment will be evaluated and initiated at T4.

Interventions

Maxillary expansion device DEVICE

The maxillary expansion device is a orthodontic appliance that is used to expand the maxilla in children.

Early maxillary expansion

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Healthy subjects without sucking habits
• Permanent maxillary central incisors and first permanent molars fully erupted. DS1M1.
• No severe crowding or protrusion in the lower arch considering the Leeway space and normal development of the arch.
• Permanent first molar in normal transversal relation.
• Crowding of the maxillary incisors with the lateral incisor just erupting ectopically or not yet emerged through the gingiva.
• Crowding greater than or equal to 6 millimeters between the upper deciduous canines.

You may not qualify if:

• Skeletal asymmetries, anomalies and syndromes.
• Previous orthodontic treatment

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (4)

Postgraduate School of Orthodontics, University of L'Aquila

Coppito, Italy

RECRUITING

Universita Degli Studi Di Milano

Milan, 20122, Italy

RECRUITING

The Institute for Postgraduate Dental Education in Jönköping

Jönköping, Sweden

RECRUITING

Emil Östlund

Örebro, 70383, Sweden

RECRUITING

Central Study Contacts

Emil Östlund, DDS

CONTACT

+46196024045; emil.ostlund@regionorebrolan.se

Farhan Bazargani, DDS

CONTACT

+46196024045; farhan.bazargani@regionorebrolan.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor will do measurements on study models. The study models will be masked when it comes to treatment modality. Surveys will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a 2-arm parallel-group, randomized controlled trial with a 1:1 allocation ratio.

Study Record Dates

• First Submitted: November 17, 2023
• First Posted: January 2, 2024
• Study Start: December 20, 2021
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2028
• Last Updated: July 18, 2025

Record last verified: 2025-05

Locations

IT (2); SE (2)