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Clinical Effectiveness of Bonded Versus Vacuum-formed Retainers

Primary Purpose

Relapse

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
V-bend Bonded Retainer
Vacuum-formed Retainer
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapse focused on measuring Orthodontic Retainers, Orthodontic Appliances, Removable, Orthodontics

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with the proper completion of orthodontic treatment and correction of the initial malocclusion.
  • Acceptable oral hygiene (assessed through clinical examination).
  • Presence of all teeth up to the second molars.
  • Clinically acceptable teeth alignment.

Exclusion Criteria:

  • Patients with any systemic condition that may have an influence on periodontal health.
  • Patients with facial deformities.
  • Initial malocclusion that required extreme corrections, large transverse expansions or orthognathic surgery.
  • History of periodontal diseases.

Sites / Locations

  • Bauru Dental School, University of São Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

V-bend Bonded Retainer

Vacuum-formed Retainer

Arm Description

The V-bend retainer was bonded in the lingual surface of the anterior teeth. The retainer was constructed using 0.024" stainless steel wires. Differently from the conventional bonded retainers, this retainer presents V-bends in the sagittal direction, parallel to the occlusal plane in each interproximal contact point of the incisors and canines. The retainers was bonded after adequate etching with phosphoric acid and application of adhesive with a low viscosity resin.

The removable Vacuum-formed retainers were made of acetate 1mm thickness. They were made at the same appointment of debonding using plaster models. The patients were instructed to use the retainers only during nights.

Outcomes

Primary Outcome Measures

Changes in Little Irregularity Index (LII)
Stability was evaluated comparing the changes in the Little Irregularity Index (LII) between time-points. The average of the linear distances between the anatomical contact points of the anterior teeth were considered.

Secondary Outcome Measures

Intercanine Distance
Distance between the cusp tips of the right and left permanent canines. In the maxilla and mandible.
Intermolar Distance
Distance between the tips of the mesiobuccal cusps of the first right and left permanent molars. In the maxilla and mandible.
Overjet
Distance between the incisal edge of the maxillary central incisor and the incisal edge of the mandibular incisor, parallel to the occlusal plane.
Overbite
Distance between the incisal edge of the upper central incisor and the incisal edge of the lower incisor, perpendicular to the occlusal plane.
Calculus Accumulation
Periodontal status was evaluated regarding the amount of calculus accumulation using the Simplified Oral Hygiene Index from Greene and Vermillion, 1978. The extension of calculus was estimated visually in all erupted teeth. Each teeth received a score ranging from 0 to 3. Minor scores indicated absence of calculus while higher scores indicated greater calculus accumulation on the tooth surfaces.
Gingival Health
Periodontal status was evaluated regarding the patients' gingival health using the Gingival Index described by Loe, 1967. The gingival health was estimated clinically with a periodontal probe in all erupted teeth. Each teeth received a score ranging from 0 to 3. Minor scores indicated acceptable gingival health while higher scores indicated greater inflammation and unacceptable gingival health.
Plaque Accumulation
Periodontal status was evaluated regarding the amount of plaque accumulation using the Plaque Index from Loe, 1967. The extension of plaque was estimated clinically using a periodontal probe in all erupted teeth. Each teeth received a score ranging from 0 to 3. Minor scores indicated absence of plaque while higher scores indicated greater plaque accumulation on the tooth surfaces.
Retainers Survival Rates
The number and cause of failures for each patient was recorded during the 12-month follow-up. From these data, the total survival rate of the retainers was estimated as a percentage, as well as its major causes of failure.
Patients' Perception
Patients' perception was assessed using a Visual Analogue Scale (VAS) containing a questionnaire with 9 questions related to the use of the retainers. Each question received a score ranging from 0 to 10. Minor scores indicated that the patient felt extremely uncomfortable during the retention period while higher scores indicated that the patients felt highly comfortable.

Full Information

First Posted
April 8, 2021
Last Updated
June 28, 2022
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT04847323
Brief Title
Clinical Effectiveness of Bonded Versus Vacuum-formed Retainers
Official Title
Clinical Effectiveness of Bonded Versus Vacuum-formed Retainers After 12 Months: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

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

5. Study Description

Brief Summary
The purpose of the study was to compare the clinical effectiveness of bonded versus vacuum-formed retainers regarding their retention capacity; periodontal health; survival rates; and patients' perception after 12 months of removal of fixed appliances. The null hypotheses considered that there was no differences between the retainers in relation to the aspects evaluated.
Detailed Description
This single-center randomized controlled trial was performed at the Department of Orthodontics, Bauru Dental School, University of São Paulo, Brazil. A total of 50 patients completing orthodontic treatment were recruited. The patients were prospectively and randomly allocated into two groups. The first group consisted of 25 patients with canine-to-canine V-bend bonded retainers; while the second group comprised 25 patients with vacuum-formed retainers. In both groups, the same retainers were installed in the maxillary and mandibular arches. Patients were evaluated at deboning (T0), after 3 months (T1), 6 months (T2), and 12 months (T3). In each appointment, digital models were obtained and the other clinical variables were evaluated. The primary and secondary outcomes were compared between retainers in the time-points evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapse
Keywords
Orthodontic Retainers, Orthodontic Appliances, Removable, Orthodontics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This was a 2-arm parallel randomized controlled trial. Therefore, the selected patients were randomly divided into two groups. Group 1: Bonded V-bend retainers. Group 2: Vacuum-formed retainers. Randomization was performed through sequentially numbered, opaque envelopes prepared by a colleague independent of the study.
Masking
Outcomes Assessor
Masking Description
Masking of the principal investigator and participants was not be possible due to the nature of the interventions. Nonetheless, the outcome assessor was blinded for the periodontal and patient perception variables.
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
V-bend Bonded Retainer
Arm Type
Active Comparator
Arm Description
The V-bend retainer was bonded in the lingual surface of the anterior teeth. The retainer was constructed using 0.024" stainless steel wires. Differently from the conventional bonded retainers, this retainer presents V-bends in the sagittal direction, parallel to the occlusal plane in each interproximal contact point of the incisors and canines. The retainers was bonded after adequate etching with phosphoric acid and application of adhesive with a low viscosity resin.
Arm Title
Vacuum-formed Retainer
Arm Type
Active Comparator
Arm Description
The removable Vacuum-formed retainers were made of acetate 1mm thickness. They were made at the same appointment of debonding using plaster models. The patients were instructed to use the retainers only during nights.
Intervention Type
Device
Intervention Name(s)
V-bend Bonded Retainer
Other Intervention Name(s)
Bonded Retainer, Canine-to-Canine Retainer, Fixed Retainer
Intervention Description
Traditional stainless steel retainer commonly bonded in the anterior teeth of the mandibular arch to maintain their alignment after orthodontic treatment.
Intervention Type
Device
Intervention Name(s)
Vacuum-formed Retainer
Other Intervention Name(s)
Thermoplastic Retainer, Clear Retainer
Intervention Description
Removable retainers made of plastic and derivatives. Currently gaining popularity due to the increased use of esthetic aligners. These clear retainers have the objective to maintain stable the results obtained after orthodontic treatment. They cover all the surfaces of the teeth up to the first or second molars.
Primary Outcome Measure Information:
Title
Changes in Little Irregularity Index (LII)
Description
Stability was evaluated comparing the changes in the Little Irregularity Index (LII) between time-points. The average of the linear distances between the anatomical contact points of the anterior teeth were considered.
Time Frame
Changes were compared at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).
Secondary Outcome Measure Information:
Title
Intercanine Distance
Description
Distance between the cusp tips of the right and left permanent canines. In the maxilla and mandible.
Time Frame
Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).
Title
Intermolar Distance
Description
Distance between the tips of the mesiobuccal cusps of the first right and left permanent molars. In the maxilla and mandible.
Time Frame
Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).
Title
Overjet
Description
Distance between the incisal edge of the maxillary central incisor and the incisal edge of the mandibular incisor, parallel to the occlusal plane.
Time Frame
Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).
Title
Overbite
Description
Distance between the incisal edge of the upper central incisor and the incisal edge of the lower incisor, perpendicular to the occlusal plane.
Time Frame
Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).
Title
Calculus Accumulation
Description
Periodontal status was evaluated regarding the amount of calculus accumulation using the Simplified Oral Hygiene Index from Greene and Vermillion, 1978. The extension of calculus was estimated visually in all erupted teeth. Each teeth received a score ranging from 0 to 3. Minor scores indicated absence of calculus while higher scores indicated greater calculus accumulation on the tooth surfaces.
Time Frame
Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).
Title
Gingival Health
Description
Periodontal status was evaluated regarding the patients' gingival health using the Gingival Index described by Loe, 1967. The gingival health was estimated clinically with a periodontal probe in all erupted teeth. Each teeth received a score ranging from 0 to 3. Minor scores indicated acceptable gingival health while higher scores indicated greater inflammation and unacceptable gingival health.
Time Frame
Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).
Title
Plaque Accumulation
Description
Periodontal status was evaluated regarding the amount of plaque accumulation using the Plaque Index from Loe, 1967. The extension of plaque was estimated clinically using a periodontal probe in all erupted teeth. Each teeth received a score ranging from 0 to 3. Minor scores indicated absence of plaque while higher scores indicated greater plaque accumulation on the tooth surfaces.
Time Frame
Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).
Title
Retainers Survival Rates
Description
The number and cause of failures for each patient was recorded during the 12-month follow-up. From these data, the total survival rate of the retainers was estimated as a percentage, as well as its major causes of failure.
Time Frame
Evaluation was performed during the 12 Months of follow-up.
Title
Patients' Perception
Description
Patients' perception was assessed using a Visual Analogue Scale (VAS) containing a questionnaire with 9 questions related to the use of the retainers. Each question received a score ranging from 0 to 10. Minor scores indicated that the patient felt extremely uncomfortable during the retention period while higher scores indicated that the patients felt highly comfortable.
Time Frame
Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients with the proper completion of orthodontic treatment and correction of the initial malocclusion. Acceptable oral hygiene (assessed through clinical examination). Presence of all teeth up to the second molars. Clinically acceptable teeth alignment. Exclusion Criteria: Patients with any systemic condition that may have an influence on periodontal health. Patients with facial deformities. Initial malocclusion that required extreme corrections, large transverse expansions or orthognathic surgery. History of periodontal diseases.
Facility Information:
Facility Name
Bauru Dental School, University of São Paulo
City
Bauru
State/Province
São Paulo
ZIP/Postal Code
17012-901
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Effectiveness of Bonded Versus Vacuum-formed Retainers

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