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Completed

NCT Number: NCT06403033

Mini-implant-supported Twin-Block in Treating Patients With Class II Division 1 Malocclusion

Correcting the skeletal class II using functional appliances, whether removable or fixed, always leads to skeletal and alveolar effects. However, some of these effects are unfavorable, the most significant being the loss of support in the lower dental arch. This loss of support leads to an uncontrolled labial inclination of the lower incisors and mesial movement of the lower; these dentoalveolar effects impact the degree of skeletal correction that can be achieved. Therefore, this study aimed to evaluate the skeletal and dentoalveolar effects following the use of a mini-implant-supported Twin-Block appliance compared to the conventional Twin-Block.

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Key information

Conditions

Orthodontic Appliance Complication Malocclusion Malocclusion, Angle Class II Malocclusion, Angle Class II, Division 1 Stomatognathic Diseases Tooth Diseases

Age range

10 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Orthodontics, Faculty of Dentistry, University of Damsacus

Damascus, DM20 HAJ72, Syria

About this study

Many attempts have been made to modify the Twin-Block appliance to decrease the dentoalveolar effects, such as omitting the upper labial bow, including torquing spurs on the upper incisors, and adding acrylic capping on the lower incisors. However, these modifications have not been successful in eliminating the dentoalveolar effects. This is because the Twin-Block and other functional appliances are supported by teeth rather than bone. As a result, the components of the appliance exert force on the teeth while the mandible attempts to return to its natural resting position. No previous clinical trial described the use of the Twin-Block appliance supported by orthodontic mini-implants and the potential benefits of using mini-implants with Twin-Block in functional treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The wrist radiograph (stage 4 S and stage 5 MP3 cap)
  • Skeletal Class II division 1 malocclusion caused by mandibular retrusion
  • ANB (5°- 9°)
  • SNB (72°- 77°)
  • overjet (5 - 8 mm),
  • Minimal crowding in dental arches (≤ 3 mm),
  • MM≤30°
  • lower second molars erupting.

Exclusion criteria

  • Previous orthodontic procedures.
  • Systemic diseases.
  • Temporal Mandibular Joint disorders.
  • Poor oral hygiene

Treatment and study plan

Mini-implant-supported Twin-Block

Device

Mini-implants will support the Twin-Block appliance during the functional treatment.

Twin-block

Device

This is the main appliance that will be used to correct the Class II deformity.

Primary outcomes

  1. Change in the overjet

    Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.

    Lateral cephalometric images were taken for each patient. This was measured sagittally from the upper central incisor edge to the labial surface of the lower central incisor (in mm).

  2. Change in the overbite

    Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.

    Lateral cephalometric images were taken for each patient. This was measured vertically from the upper to the lower central incisors' edges (in mm).

  3. Change in the molar relationship

    Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.

    Lateral cephalometric images were taken for each patient. This was measured sagittally from the mesial cusp of the maxillary first permanent molar to the mesial cusp of the mandibular first permanent molar (in mm).

  4. Change in the position of the maxillary base

    Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.

    Lateral cephalometric images were taken for each patient. This was measured sagittally from A point to a vertical reference plane (in mm).

  5. Change in the position of the mandibular base

    Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.

    Lateral cephalometric images were taken for each patient. This was measured sagittally from Pogonion Point to a vertical reference plane (in mm).

  6. Change in the mandibular position relative to the upper jaw

    Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.

    Lateral cephalometric images were taken for each patient. This was measured sagittally from A point to Pogonion Point (in mm).

  7. Change in condylar head position

    Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.

    Lateral cephalometric images were taken for each patient. This was measured sagittally from Condylion point to the vertical reference plane (in mm).

  8. Change in the composite mandibular length

    Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.

    Lateral cephalometric images were taken for each patient. This was measured sagittally from Condylion Point to the Pogonion Point (in mm).

  9. Change in position of the maxillary incisor

    Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.

    Lateral cephalometric images were taken for each patient. This was measured sagittally from the upper central incisor edge to the A Point (in mm).

  10. Change in position of the mandibular incisor

    Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.

    Lateral cephalometric images were taken for each patient. This was measured sagittally from the lower central incisor edge to the Pogonion Point (in mm).

  11. Change in position of the maxillary permanent first molar

    Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.

    Lateral cephalometric images were taken for each patient. This was measured sagittally from the mesial cusp of the maxillary first permanent molar to A Point (in mm).

  12. Change in position of the mandibular permanent first molar

    Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.

    Lateral cephalometric images were taken for each patient. This was measured sagittally from the mesial cusp of the mandibular first permanent molar to the Pogonion Point (in mm).

  13. Change in the ramus height

    Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.

    Lateral cephalometric images were taken for each patient. The distance was measured vertically from the Articular Point (Ar) to the Gonion Point (Go) in millimeters.

  14. Change in the corpus length

    Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.

    Lateral cephalometric images were taken for each patient. This was measured sagittally from the Gonion (Go) Point to the Mention (Me) Point. The distance is measured in mm.

  15. Change in MM angle

    Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.

    Lateral cephalometric images were taken for each patient. This angle, measured in degrees, represented the amount of vertical divergence between the upper and lower jaws in the cephalometric analysis. It is calculated for the internal angle formed by the intersection between the maxillary and mandibular planes.

  16. Change in the SN-OP

    Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.

    Lateral cephalometric images were taken for each patient. This angle, measured in degrees, represented the relationship between the occlusal plane (OP) and the anterior cranial base (the distance between Sella (S) and Nasion (N)) in the vertical direction.

  17. Change in the SN-MP

    Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.

    Lateral cephalometric images were taken for each patient This angle, measured in degrees, represented the relationship between the lower jaw plane and the cranial base in the vertical direction.

  18. Change in the Bjork sum (N-S-Ar + S-Ar-Go +Ar-Go-Me)

    Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.

    Lateral cephalometric images were taken for each patient. This angle, measured in degrees, was the sum of three angles: the saddle angle (N-S-Ar angle), the articular angle (S-Ar-Go), and the gonial angle (Ar-Go-Me).

  19. Change in the inclination of the upper incisors.

    Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.

    Lateral cephalometric images were taken for each patient. This angle, measured in degrees, represented the relationship between the upper incisor axis and the anterior cranial base in the anteroposterior direction. It was measured between the upper incisor axis and the SN plane.

  20. Change in the L1-MP angle

    Time frame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.

    Lateral cephalometric images were taken for each patient. This angle, measured in degrees, represented the relationship between the lower incisor axis and the mandibular base in the anteroposterior direction. It was measured between the lower incisor axis and the Go-Me plane.

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

Evaluation of the Skeletal and Dentoalveolar Effects of Mini-implant-supported Twin-Block in Treating Growing Patients With Class II Division 1 Malocclusion: A Two-arm Randomized Controlled Clinical Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 7, 2024
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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