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A prospective analysis of biocompatibility and retention behavior with directly printed retentionsplints after orthodontic therapy.

A prospective analysis of biocompatibility and retention behavior with directly printed retentionsplints after orthodontic therapy.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00036902
Enrollment
50
Registered
2025-05-14
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

K05.0 K12 Z01

Interventions

Group 1: Biocompatibility (Intervention I) and retention behavior (Intervention II) of the observation group at specific intervention time points: Biocompatibility (Intervention I) and retention beha
(extraoral signs may also be possible) - Visual assessment in consultation with, if necessary with the aid of histological assessment (e.g. in the case of oral lichen planus) - immediate allergic reac
delayed type IV reactions are tested with the aid of an epicutaneous test (= patch test), if possible with the aid of individual substances and material plates - Toxic-irritant contact reactions with

Sponsors

Poliklinik für Kieferorthopädie, Universitätsklinikum Regensburg
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Patients have permanent dentition, which is usually present from the age of 12 ± 1 year. However, it should be noted that the presence of permanent dentition depends very much on the individual patient. - No gaps or crowding greater than 2 mm - Good general state of health - evidence of a good standard of oral hygiene (determined by questioning and clinical examination) - the subjects have a complete set of teeth from the 1st molar to the 1st molar in the upper jaw (exception: individual teeth have already been extracted to create space) - patients must be willing to agree to retention and adhere to the wearing protocol (every night)

Exclusion criteria

Exclusion criteria: - Syndromes/cleft lip jaw palate/genetic diseases - any general medical health problems that may affect gum health, such as antibiotic shielding for bacteremia prophylaxis, blood thinners, diabetes mellitus, epilepsy or physical or mental disability - Patients only received early orthodontic treatment - Deep untreated caries (must be treated before participation) - Cleft palate or severe facial deformities - Extremely poor oral hygiene - Adhesively bonded retainer in the upper jaw already in situ - multiple non-attachment of permanent teeth

Design outcomes

Primary

MeasureTime frame
Biocompatibility = tissue compatibility. This describes the ability of a material to remain in the patient's body with an appropriate immune response. In dentistry, this includes: - inflammatory changes (e.g. gingivitis or stomatitis) - allergic reactions (especially type I or type IV) - toxic-irritative contact reactions - lichenoid reactions

Secondary

MeasureTime frame
Retention behavior Little Irregularity Index (LII): Sum of the displacement of the five anatomical contact points in the vestibulooral direction Intercanine distance (ICD): Distance between the cusp tips of the right and left canine teeth Intermolar distance (IMD) : Distance between the mesiobuccal cusp tips of the right and left first permanent molars Upper arch length (AL): The sum of the right and left distances from the mesiobuccal cusp tips of the first permanent molars to the contact point of the central incisors Overjet (OJ): The greatest horizontal distance between the maxillary and mandibular incisors. Overbite (OB): The greatest vertical distance from incisal edge to incisal edge of the anterior teeth.

Countries

Germany

Contacts

Public ContactThomas Wendl

Poliklinik für Kieferorthopädie, Universitätsklinikum Regensburg

thomas.wendl@ukr.de+49 941 944 16091

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026