Skip to content

Study to Investigate the Influence of Precision Bite Ramps on the Correction of Deep Bite in Patients Undergoing Aligner Therapy: A Randomized Controlled Trial

Study to Investigate the Influence of Precision Bite Ramps on the Correction of Deep Bite in Patients Undergoing Aligner Therapy: A Randomized Controlled Trial - Influence of Precision Bite Ramps on the Correction of Deep Bite

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00034889
Enrollment
100
Registered
2024-08-15
Start date
2024-12-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Deep bite, dental malpositions K07

Interventions

Group 1: The Adult-Ctr group consists of patients undergoing treatment with the Invisalign Comprehensive System (Align Technology, Santa Clara, CA) without Precision Bite Ramps. Group 2: The Adult-Ctr

Sponsors

Zentrum der Zahn-, Mund- und Kieferheilkunde der Johann Wolfgang Goethe-Universität Frankfurt am Main Poliklinik für Kieferorthopädie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 40 Years

Inclusion criteria

Inclusion criteria: Patients undergoing treatment with the Invisalign System (Align Technology, Santa Clara, CA) in both arches, with a deep overbite of = 4 mm or = 50%, and good adherence to aligner wear (wearing the aligners for over 20 hours per day).

Exclusion criteria

Exclusion criteria: Supernumerary teeth. Absence of one or more permanent teeth (excluding wisdom teeth). Syndromes or systemic diseases. Cavities. Inadequate dental fillings. Poor oral hygiene. Patients requiring extraction treatments. Use of adjunctive devices other than attachments. In children: More than one extracted or exfoliated primary tooth per quadrant.

Design outcomes

Primary

MeasureTime frame
Impact of Bite Ramps on the efficiency of aligners in the treatment of deep bite. For each patient, 8 digital models will be measured: (1) before treatment or T0, (2) 10 weeks into treatment or T1, (3) post-treatment models or T2, and (4) predicted models or Tx. The overbite will be measured at the greatest overbite between the two opposing teeth in the upper and lower arches (either central or lateral incisors) using the Onyxceph software (Image Instruments, Germany). The method of best-fit surface registration used in the study by Shahabuddin et al. will be used to measure individual tooth movements, including the direction and magnitude of movements as well as changes in angulation.

Secondary

MeasureTime frame
Predictability of planed results The predictability of tooth movement will be calculated as the percentage of the achieved predicted expansion (achieved expansion/predicted expansion x100). Additionally, all diagnostic data, which is collected independently of this study and routinely during the course of orthodontic therapy (including extraoral photos, orthopantomograms, and lateral cephalograms), will be analyzed and evaluated. The measurements will be repeated at an interval of 30 days by the same examiner to calculate intra-rater reliability. The mean values of these two measurements will be used for the main analysis.

Countries

Germany

Contacts

Public ContactStefan Kopp

Zentrum der Zahn-, Mund- und Kieferheilkunde der Johann Wolfgang Goethe-Universität Frankfurt am Main Poliklinik für Kieferorthopädie

kopp@med.uni-frankfurt.de+49 69 6301 6733

Outcome results

None listed

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