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Evaluation of a new adhesive system for orthodontic braces for a 6-month period

Evaluation of the flash-free adhesive system for a 6-month period: a split-mouth trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN26731749
Enrollment
30
Registered
2020-10-07
Start date
2018-09-17
Completion date
Unknown
Last updated
2023-07-04

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

Conditions

Orthodontic malocclusion Oral Health

Interventions

Patients willing to participate in this study receive orthodontic treatment with a split-mouth design, i.e. the mouth is divided into four experimental segments that are randomly assigned to either th

Sponsors

Ondokuz Mayis University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Willingness to participate in this research project 2. Fully erupted maxillary and mandibular teeth with intact buccal enamel 3. Angle Class I and mild Class II malocclusions 4. Non-extraction patients 5. Normal overbite (1-2 mm) 6. Absence of severe rotations. Severe rotations would have prevented bracket placement or correct bracket placement at the first appointment 7. Absence of pretreatment of teeth with any chemical agents 8. Good oral hygiene, i.e. no bleeding upon probing

Exclusion criteria

Exclusion criteria: 1. Patients with skeletal problems 2. Patients with missing teeth 3. Patients with systemic disease 4. Patients with a previous history of orthodontic treatment

Design outcomes

Primary

MeasureTime frame
Bracket failure, i.e. bracket detachment from the tooth, is visually observed. Bracket failure can occur at any timepoint during the observation period. Bracket failure was recorded at the routine monthly controls of the patients.

Secondary

MeasureTime frame
Type of failure: the bracket may have detached from the tooth intact with adhesive or without adhesive. Furthermore, the bracket may have fractured. These types of failures can occur at any timepoint during the observation period. These types of failures were recorded at the routine monthly controls of the patients.

Countries

Turkey

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 9, 2026