Orthodontic Treatment in Adolescents With Crowding and Displaced Teeth

NCT05664282 | Active Not Recruiting

• 1 other identifier: FO 2022/474
• Study Type: interventional
• Target: 131
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose is to fill knowledge gaps identified for orthodontic treatment using a novel study design that has not been implemented in the dental field or in orthodontics. The study design comprises an analysis, where outcomes of two techniques are assessed at several efficacy levels by different methods. Moreover, the project is designed to include a longtime follow-up that is unique in orthodontic treatment. The aim is to compare two techniques with buccally fixed appliance in a multicenter RCT of adolescents aged 12 to 17 years with crowding and tooth displacement. In the intervention group, patients will be treated with a self-ligating bracket system, and in the control group with a conventional bracket system. Outcomes will be assessed from the clinical, patients' and economic perspectives as:

• Tooth alignment, function and adverse side effects
• Patients' perception of pain, function and quality of life
• Cost-effectiveness.

Conditions

Crowding, Tooth; Orthodontic

Keywords

tooth alignment; function; adverse side effects; cost-effectiveness

Outcome Measures

Primary Outcomes (2)

• Evaluating change in treatment outcomes at the clinical level

  The patients will be documented with dental casts at baseline, after 9-12 months treatment and at end of active treatment. To evaluate change in tooth alignment, function stability and treatment success Peer Assessment Rating index (PAR) will be used on dental casts. PAR scores are assigned to different malocclusion traits and the difference between pre- and posttreatment scores indicates the degree of improvement as a result of orthodontic intervention.

  2 years

• Evaluating longitudinal change in treatment outcomes

  The patients will be documented with dental casts end of active treatment and 5 years after active treatment. To evaluate change in stability Peer Assessment Rating index (PAR) will be used on dental casts.

  5 years

Secondary Outcomes (4)

• To evaluate the rate of root resorption and marginal bone loss after treatment

  2 years

• To evaluate caries incidence

  2 years

• To assess pain experienced by the patients with a validated Visual Analog Scale

  2 years

• To perform a cost-effectiveness analysis

  2 years

Study Arms (2)

Damon self-ligating brackets

ACTIVE COMPARATOR

A multi-centre two-arm parallel-group randomized controlled trial with a 1:1 allocation ratio, comparing/evaluating tooth alignment, function and adverse side effects, Patients' perception of pain, function and quality of life Cost-effectiveness for adolescents with crowding and displaced teeth treated with self-ligating (Damon).

Device: Damon self-ligating brackets

Victory conventional brackets

ACTIVE COMPARATOR

A multi-centre two-arm parallel-group randomized controlled trial with a 1:1 allocation ratio, comparing/evaluating tooth alignment, function and adverse side effects, Patients' perception of pain, function and quality of life Cost-effectiveness for adolescents with crowding and displaced teeth treated with conventional brackets (Victory).

Device: Victory self-ligating brackets

Interventions

Damon self-ligating brackets DEVICE

Damon self-ligating brackets

Victory self-ligating brackets DEVICE

Victory conventional brackets

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• Skeletal anomalies
• Rheumatoid arthritis
• Previous orthodontic treatment
• Impacted teeth
• Ongoing sucking habits
• Previous trauma to teeth or jaws with subjective, clinical, or radiographic signs: periapical pathology; probing depth ≥ 5 mm at ≥ 4 surfaces of central incisors or first molars
• Visible plaque grade 3
• Treatment plan including extractions or other appliances than fixed buccal appliances
• Communication difficulties.

Sponsors & Collaborators

• Malmö University: lead

Related Publications (2)

• Matilainen LB, Johansson K, Wiaderny M, Brechter A, Petren S, D'Anto V, Paulsson L. Treatment Effects and Treatment Time in Adolescents With Crowded and Displaced Teeth Treated With Fixed Appliance Systems Without Extractions: A Multi-Centre Randomised Controlled Trial. Orthod Craniofac Res. 2025 Dec;28(6):929-942. doi: 10.1111/ocr.70005. Epub 2025 Jul 23.

  PMID: 40698883 DERIVED

• Johansson K, Christell H, Brechter A, Paulsson L. Evaluation of External Apical Root Resorption and the Relevance of Intermediate Radiography in Non-Extraction Treatment With Fixed Appliances for Adolescents With Crowding: A Multicenter Randomised Controlled Trial Using CBCT. Orthod Craniofac Res. 2025 Jun;28(3):515-526. doi: 10.1111/ocr.12903. Epub 2025 Feb 3.

  PMID: 39899339 DERIVED

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Liselotte Paulsson

  Malmö University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: December 23, 2022
• Study Start: May 1, 2016
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 23, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share