Efficacy and Cost-effectiveness of Orthodontic Retention Protocols

NCT ID: NCT05121220

Last Updated: 2022-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

152 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-15

Study Completion Date

2023-11-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Objective is to assess changes of dentition and periodontium, and hygiene in retention after the end of the active phase of orthodontic treatment, and relationship with gender, type of retention appliance, pre-therapeutic condition of dentition and duration of active phase of treatment.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A total of 152 subjects will be recruited and randomly assigned into three groups. First group will have a square 8-stranded 0.673x0.268 mm retainer wire bonded in mandibular teeth after completing the active phase of comprehensive orthodontic treatment with fixed appliances. Retainer will be bonded on lingual site canine to canine on each tooth. Second group will have a round 6-stranded 0.40 mm retainer in mandible. Third group will be without fixed retainer, only with thermoplastic vacuum-formed removable Essix retainer in mandible.

Subjects will be examined before orthodontic treatment (T0), upon completion of treatment (T1), six months in retention (T2), two years (T3) and three years in retention (T4). Changes in intercanine width, relapse (unexpected tooth movements), retainer failure, accumulation of biofilm, calculus and gingivitis will be assessed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Orthodontic Relapse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

fixed mandibular lingual rectangular retainer 0.673 x 0.268 mm

0.673 x 0.268 mm 8-stranded wire Bond A Braid (Reliance Orthodontic Products, USA) will be bonded in mandible canine to canine on each tooth using Filtek flowable composite (Ivoclar Vivadent, Lichtenstein) and Multilink adhesive (3M, USA).

Group Type EXPERIMENTAL

fixed retainer

Intervention Type DEVICE

bonded lingual mandibular fixed retainer on frontal teeth 33-43

fixed mandibular lingual round retainer 0.40 mm

0.40 mm round 6-stranded wire (Forestadent, Germany) will be bonded on 6 mandibular frontal teeth, canine to canine on each tooth using Filtek flowable composite (Ivoclar Vivadent, Lichtenstein) and Multilink adhesive (3M, USA).

Group Type EXPERIMENTAL

fixed retainer

Intervention Type DEVICE

bonded lingual mandibular fixed retainer on frontal teeth 33-43

removable mandibular retainer

Group without fixed retainer will be wearing removable thermoplastic vacuum-formed Essix retainer

Group Type ACTIVE_COMPARATOR

removable retainer

Intervention Type DEVICE

thermoplastic vacuum-formed removable mandibular retainer

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fixed retainer

bonded lingual mandibular fixed retainer on frontal teeth 33-43

Intervention Type DEVICE

removable retainer

thermoplastic vacuum-formed removable mandibular retainer

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Inclusion Criteria: finished orthodontic treatment, participants must have all permanent teeth Exclusion Criteria: hypodontia, missing teeth
Minimum Eligible Age

11 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Zagreb School of Dental Medicine, Zagreb, Croatia

UNKNOWN

Sponsor Role collaborator

University of Rijeka Faculty of Dental Medicine, Rijeka, Croatia

UNKNOWN

Sponsor Role collaborator

Poliklinika Orthonova

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

silvija kanižaj ugrin

Dentist, Orthodontic specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Silvija Kanižaj Ugrin, DDM

Role: PRINCIPAL_INVESTIGATOR

Poliklinika Orthonova

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Poliklinika Orthonova

Zagreb, , Croatia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Croatia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Silvija Kanižaj Ugrin, DDM

Role: CONTACT

00385915232860

Stjepan Špalj, PhD

Role: CONTACT

00385916119853

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Silvija Kanižaj Ugrin, DMD

Role: primary

+385915232860

References

Explore related publications, articles, or registry entries linked to this study.

Kanizaj Ugrin S, Spalj S. Comparison of efficacy of thermoplastic retainer with round and rectangular bonded lingual wire retainer in the mandible two years after orthodontic treatment: a randomised controlled trial. Clin Oral Investig. 2024 Mar 1;28(3):183. doi: 10.1007/s00784-024-05572-y.

Reference Type DERIVED
PMID: 38424224 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

66771011

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.