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Efficacy and Cost-effectiveness of Orthodontic Retention Protocols (orthoretenti)

Primary Purpose

Orthodontic Relapse

Status
Recruiting
Phase
Not Applicable
Locations
Croatia
Study Type
Interventional
Intervention
fixed retainer
removable retainer
Sponsored by
Poliklinika Orthonova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Orthodontic Relapse focused on measuring retention wire, fixed retainer, orthodontic therapy

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers
Inclusion Criteria: finished orthodontic treatment, participants must have all permanent teeth Exclusion Criteria: hypodontia, missing teeth

Sites / Locations

  • Poliklinika OrthonovaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

fixed mandibular lingual rectangular retainer 0.673 x 0.268 mm

fixed mandibular lingual round retainer 0.40 mm

removable mandibular retainer

Arm Description

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).

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

Outcomes

Primary Outcome Measures

severity of relapse (unexpected tooth movement in mandibular frontal area) at 1 year
the unabbreviated scale title: Little Irregularity Index (used to measure the crowding)- numerical rating scale in millimeters the minimum and maximum values: 0,10 higher scores mean a worse outcome lower scores mean a better outcome
severity of relapse (unexpected tooth movement in mandibular frontal area) at 2 years
the unabbreviated scale title: Little Irregularity Index (used to measure the crowding)- numerical rating scale in millimeters the minimum and maximum values: 0,10 higher scores mean a worse outcome lower scores mean a better outcome
severity of relapse (unexpected tooth movement in mandibular frontal area) at 3 years
the unabbreviated scale title: Little Irregularity Index (used to measure the crowding)- numerical rating scale in millimeters the minimum and maximum values: 0,10 higher scores mean a worse outcome lower scores mean a better outcome
incidence of retainer failure (debonding, breakage) at 2 years
percentage of cases with at least one fixed retainer failure, the minimum and maximum values 0%,100% higher scores mean a worse outcome, lower scores mean a better result
incidence of retainer failure (debonding, breakage) at 3 years
percentage of cases with at least one fixed retainer failure, the minimum and maximum values 0%,100% higher scores mean a worse outcome, lower scores mean a better result
extent of biofilm accumulation at 2 years
the unabbreviated scale title: Silness and Loe Plaque Index-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better result
extent of biofilm accumulation at 3 years
the unabbreviated scale title: Silness and Loe Plaque Index-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better result

Secondary Outcome Measures

incidence of intercanine width change
percentage of cases with intercanine width change, the minimum and maximum values 0%,100% higher scores mean a worse outcome, lower scores mean a better result
changes of intercanine width
the unabbreviated scale title: intercanine width change in millimeters, the minimum and maximum values 0,5, higher scores mean a worse outcome, lower result mean a better outcome
extent of calculus accumulation at 2 years
the unabbreviated scale title: Calculus Surface Index (CSI)-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better outcome
extent of calculus accumulation at 3 years
the unabbreviated scale title: Calculus Surface Index (CSI)-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better outcome

Full Information

First Posted
October 2, 2021
Last Updated
May 3, 2022
Sponsor
Poliklinika Orthonova
Collaborators
University of Zagreb School of Dental Medicine, Zagreb, Croatia, University of Rijeka Faculty of Dental Medicine, Rijeka, Croatia
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1. Study Identification

Unique Protocol Identification Number
NCT05121220
Brief Title
Efficacy and Cost-effectiveness of Orthodontic Retention Protocols
Acronym
orthoretenti
Official Title
Efficacy and Cost-effectiveness of Orthodontic Retention Protocols
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
November 15, 2022 (Anticipated)
Study Completion Date
November 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Poliklinika Orthonova
Collaborators
University of Zagreb School of Dental Medicine, Zagreb, Croatia, University of Rijeka Faculty of Dental Medicine, Rijeka, Croatia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthodontic Relapse
Keywords
retention wire, fixed retainer, orthodontic therapy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
152 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
fixed mandibular lingual rectangular retainer 0.673 x 0.268 mm
Arm Type
Experimental
Arm Description
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).
Arm Title
fixed mandibular lingual round retainer 0.40 mm
Arm Type
Experimental
Arm Description
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).
Arm Title
removable mandibular retainer
Arm Type
Active Comparator
Arm Description
Group without fixed retainer will be wearing removable thermoplastic vacuum-formed Essix retainer
Intervention Type
Device
Intervention Name(s)
fixed retainer
Intervention Description
bonded lingual mandibular fixed retainer on frontal teeth 33-43
Intervention Type
Device
Intervention Name(s)
removable retainer
Intervention Description
thermoplastic vacuum-formed removable mandibular retainer
Primary Outcome Measure Information:
Title
severity of relapse (unexpected tooth movement in mandibular frontal area) at 1 year
Description
the unabbreviated scale title: Little Irregularity Index (used to measure the crowding)- numerical rating scale in millimeters the minimum and maximum values: 0,10 higher scores mean a worse outcome lower scores mean a better outcome
Time Frame
1 year
Title
severity of relapse (unexpected tooth movement in mandibular frontal area) at 2 years
Description
the unabbreviated scale title: Little Irregularity Index (used to measure the crowding)- numerical rating scale in millimeters the minimum and maximum values: 0,10 higher scores mean a worse outcome lower scores mean a better outcome
Time Frame
2 years
Title
severity of relapse (unexpected tooth movement in mandibular frontal area) at 3 years
Description
the unabbreviated scale title: Little Irregularity Index (used to measure the crowding)- numerical rating scale in millimeters the minimum and maximum values: 0,10 higher scores mean a worse outcome lower scores mean a better outcome
Time Frame
3 years
Title
incidence of retainer failure (debonding, breakage) at 2 years
Description
percentage of cases with at least one fixed retainer failure, the minimum and maximum values 0%,100% higher scores mean a worse outcome, lower scores mean a better result
Time Frame
2 years
Title
incidence of retainer failure (debonding, breakage) at 3 years
Description
percentage of cases with at least one fixed retainer failure, the minimum and maximum values 0%,100% higher scores mean a worse outcome, lower scores mean a better result
Time Frame
3 years
Title
extent of biofilm accumulation at 2 years
Description
the unabbreviated scale title: Silness and Loe Plaque Index-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better result
Time Frame
2 years
Title
extent of biofilm accumulation at 3 years
Description
the unabbreviated scale title: Silness and Loe Plaque Index-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better result
Time Frame
3 years
Secondary Outcome Measure Information:
Title
incidence of intercanine width change
Description
percentage of cases with intercanine width change, the minimum and maximum values 0%,100% higher scores mean a worse outcome, lower scores mean a better result
Time Frame
3 years
Title
changes of intercanine width
Description
the unabbreviated scale title: intercanine width change in millimeters, the minimum and maximum values 0,5, higher scores mean a worse outcome, lower result mean a better outcome
Time Frame
2 years, 3 years
Title
extent of calculus accumulation at 2 years
Description
the unabbreviated scale title: Calculus Surface Index (CSI)-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better outcome
Time Frame
2 years
Title
extent of calculus accumulation at 3 years
Description
the unabbreviated scale title: Calculus Surface Index (CSI)-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better outcome
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
incidence of relapse at 2 years
Description
the unabbreviated scale title: percentage of relapsed cases; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better outcome
Time Frame
2 years
Title
incidence of relapse at 3 years
Description
the unabbreviated scale title: percentage of relapsed cases; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better outcome
Time Frame
3 years
Title
extent of gingivitis at 2 years
Description
the unabbreviated scale title: Bleeding on probing (BOP)-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better result
Time Frame
2 years
Title
extent of gingivitis at 3 years
Description
the unabbreviated scale title: Bleeding on probing (BOP)-ratio of measuring sites in mandibular central sextant; the minimum and maximum values 0%,100%, higher scores mean a worse outcome, lower scores mean a better result
Time Frame
3 years
Title
duration of orthodontic treatment in months
Description
the unabbreviated scale title: numerical rating scale the minimum and maximum values: 0,30
Time Frame
1 year
Title
satisfaction with stability of results in retention period
Description
Participant's satisfaction with stability of results as assessed using a 5-point Likert scale. Scores range from "very unsatisfied" (1) to "very satisfied" (5). Higher scores mean a better outcome, lower scores mean a worse outcome
Time Frame
3 years
Title
costs total
Description
calculation of costs of retention: failures and new retainers in euros
Time Frame
3 years
Title
loss of productivity
Description
the unabbreviated scale title: number of check-ups in retention period; the minimum and maximum values 0,10; higher scores mean a worse outcome, lower scores mean a better result the minimum and maximum values: 0,30
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: finished orthodontic treatment, participants must have all permanent teeth Exclusion Criteria: hypodontia, missing teeth
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Silvija Kanižaj Ugrin, DDM
Phone
00385915232860
Email
kanizaj.ugrin@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Stjepan Špalj, PhD
Phone
00385916119853
Email
stjepan.spalj@fdmri.uniri.hr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Silvija Kanižaj Ugrin, DDM
Organizational Affiliation
Poliklinika Orthonova
Official's Role
Principal Investigator
Facility Information:
Facility Name
Poliklinika Orthonova
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Silvija Kanižaj Ugrin, DMD
Phone
+385915232860
Email
kanizaj.ugrin@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
on request

Learn more about this trial

Efficacy and Cost-effectiveness of Orthodontic Retention Protocols

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