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Stability of printed versus conventional retainers: randomized clinical trial

Stability of 3x3 digital printed versus conventional retainers: randomized clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2fvknfd
Enrollment
Unknown
Registered
2023-11-20
Start date
2024-01-20
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malocclusion

Interventions

This study consists in a parallel randomized clinical trial with two experimental groups. A sample of 50 patients, with complete permanent dentition, undergoing the finalization of orthodontic treatme
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V03.175.250.500.500

Sponsors

Faculdade de odontologia de Bauru - Universidade de São Paulo
Lead Sponsor
Faculdade de odontologia de Bauru - Universidade de São Paulo
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Volunteers in the final phase of orthodontic treatment; of both sexes; in the permanent denture phase; with erupted second molars; all dental elements present without changes in shape or number; adequate correction of malocclusion and alignment of dental elements; good collaboration and oral hygiene

Exclusion criteria

Exclusion criteria: Volunteer who had complex initial malocclusions that required large transverse expansions and/or orthognathic surgery; poor oral hygiene; history of periodontal disease or systemic conditions that may influence periodontal health; any type of condition that makes it impossible to carry out clinical care

Design outcomes

Primary

MeasureTime frame
Little's Irregularity Index: measurements of the linear distance from the anatomical contact points of each lower incisor to the adjacent tooth will be performed, the sum of these five irregularities representing the relative degree of crowding.;Arch Dimensions (Intercanine, interpremolar and intermolar distance): distances from the cusp tip of the left canine, first premolar and first molar to the mesiobuccal cusp tip of the contralateral teeth, respectively.;Overjet: will be measured through the distance from the middle of the incisal edge closest to the buccal surface of the maxillary right central incisor to the buccal surface of the antagonist mandibular incisor, parallel to the occlusal plane.;Overbite: vertical distance to be measured between the point where the incisal edge of the upper right central incisor overlaps the buccal surface of the antagonist lower incisor to its respective incisal edge.;Superimposition of 3D models: For a three-dimensional analysis of post-orthodontic treatment stability and tooth movements that may occur in the arch after installation of the retention protocols studied in this research, overlays of the digital models (T0, T1, T2 and T3) will be performed in the Slicer CMF program (version 3.1, www.slicer.org). Being based on points and regions of interest such as: Palatal wrinkles in the maxillary model and tip of the mesiobuccal cusp of the first molar, Buccal cusp of the first premolar, canine bilaterally and mucogingival junction in the mandibular models. Thus, measurements of three-dimensional linear distances and the amount of directional changes in each plane of 3D space (x, y, and z axes: lateral-lateral or transverse, anterior-posterior or sagittal and superior-inferior or vertical, respectively, will be analyzed.

Secondary

MeasureTime frame
Periodontal health (calculus index, plaque index and gingival index): Patients will have the buccal, lingual, mesial and distal surfaces of all teeth clinically evaluated at T0, T1, T2 and T3 to obtain the amount of calculus accumulation (Simplified Oral Hygiene Index - SOHI), Modified Gingival Index (MGI) and Plaque Index (PI), already validated and used in previous studies.;Survival and failure rates of retainers: The amount and cause of each volunteer's upper and lower retainer failures will be recorded during follow-up times T1, T2 and T3. The presence of adhesive failures, fractures, detachment and loss of retainers will be observed. Therefore, their survival rate will be obtained as a percentage. ;Patient perception: A Likert scale of patients' perception of the use of restraint will be applied during the T1, T2 and T3 follow-up. Statements regarding aesthetics, ease of cleaning and acceptance of containment will be presented, and the volunteer will be invited to express their degree of agreement with the sentence. There will be 5 points among the response options, following the model below: 1) I am satisfied with the aesthetic appearance of the retainer. 1- Totally disagree. 2- Disagree. 3- Indifferent (or neutral). 4- I agree. 5- Totally agree. 2) It was easy for me to clean the containment. 1- Totally disagree. 2- Disagree. 3- Indifferent (or neutral). 4- I agree. 5- Totally agree. 3) I am comfortable with fit, speech and function when wearing a retainer. 1- Totally disagree. 2- Disagree. 3- Indifferent (or neutral). 4- I agree. 5- Totally agree.

Countries

Brazil

Contacts

Public ContactHeloísa Cavalcanti

Faculdade de odontologia de Bauru - Universidade de São Paulo

heloisa_nelson@usp.br55 (14) 3235-8369

Outcome results

None listed

Source: REBEC (via WHO ICTRP)