NCT04616755

Brief Summary

After orthodontic treatment 3 different retention devices will be compared.Thirty patients in each group; Group 1) Bonded retainer 13-23, Group 2)Bonded retainer 12-22 and Group 3) Vacuum-formed retainer covering all erupted teeth in the maxilla. Retention capacity between these three devices will be compared after 2 years of retention by measuring Contact Point displacements (CPD) between 6 anterior teeth and sum of 5 anterior CPDs called Little´s Irregularity Index (LII).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 23, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 5, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

5.3 years

First QC Date

October 23, 2020

Last Update Submit

November 10, 2020

Conditions

Orthodontic Appliance Complication

Keywords

Retention devicesRelapseMaxillary incisorsIrregularity

Outcome Measures

Primary Outcomes (2)

  • Changes in LII (sum of 5 contact point discrepancy)among 6 maxillary front teeth

    Sum of five single contact points of maxillary anterior teeth

    2 years after retention device in place

  • Changes in CPD

    Changes in single contact point discrepancy of five maxillary anterior teeth

    2 years after retention device in place

Secondary Outcomes (2)

  • Intercanine distance

    2 years after retention device in place

  • Intermolar distance

    2 years after retention device in place

Study Arms (3)

Bonded retainer 13-23

ACTIVE COMPARATOR

This group have bonded retainer behind six front teeth in the maxilla to keep front teeth stable.

Other: Measuring changes of Little´s irregularity index ( sum of 5 contact point discrepancies together) measured in mm 2 years after retention have been I place.

Bonded retainer 12-22

ACTIVE COMPARATOR

This group have bonded retainer behind four front teeth in the maxilla to keep front teeth stable.

Other: Measuring changes of Little´s irregularity index ( sum of 5 contact point discrepancies together) measured in mm 2 years after retention have been I place.

Vacuum-formed retainer

ACTIVE COMPARATOR

This group have Vacuum-formed retainer covering all erupted teeth in maxilla to keep front teeth stable

Other: Measuring changes of Little´s irregularity index ( sum of 5 contact point discrepancies together) measured in mm 2 years after retention have been I place.

Interventions

Measuring changes of Little´s irregularity index ( sum of 5 contact point discrepancies together) measured in mm 2 years after retention have been I place.OTHER

Measuring changes occurred under 2 years which the retention devices have been in place between the groups

Also known as: Measuring changes of 5 single Contact point displacements in mm 2 years after retention have been I place.
Bonded retainer 12-22Bonded retainer 13-23Vacuum-formed retainer

Eligibility Criteria

Age11 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Young children age between 11 to 19 years old undergone orthodontic treatment.

You may not qualify if:

  • Syndrome patients
  • Skeletal discrepancy
  • missing maxillary anterior teeth
  • Adults

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Naraghi S, Ganzer N, Bondemark L, Sonesson M. Stability of maxillary anterior teeth during retention and 1 year after removal of retention-an RCT on adolescents retained with two different bonded retainers and a vacuum-formed retainer. Eur J Orthod. 2023 Nov 30;45(6):629-636. doi: 10.1093/ejo/cjad020.

    PMID: 37119264DERIVED

  • Sonesson M, Naraghi S, Bondemark L. Cost analysis of two types of fixed maxillary retainers and a removable vacuum-formed maxillary retainer: a randomized controlled trial. Eur J Orthod. 2022 Mar 30;44(2):197-202. doi: 10.1093/ejo/cjab080.

    PMID: 35021204DERIVED

  • Naraghi S, Ganzer N, Bondemark L, Sonesson M. Stability of maxillary anterior teeth after 2 years of retention in adolescents: a randomized controlled trial comparing two bonded and a vacuum-formed retainer. Eur J Orthod. 2021 Apr 3;43(2):152-158. doi: 10.1093/ejo/cjaa077.

    PMID: 33351886DERIVED

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
All study casts will be scanned without name just with a number and assessor do not know which group they belong to.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Three groups with different retention devices
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2020

First Posted

November 5, 2020

Study Start

April 1, 2013

Primary Completion

August 1, 2018

Study Completion

August 1, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share