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

D

Damascus University

Status

Completed

Conditions

Malocclusion, Angle Class II, Division 1
Orthodontic Appliance Complication

Treatments

Device: Mini-implant-supported Twin-Block
Device: Twin-Block

Study type

Interventional

Funder types

Other

Identifiers

NCT06403033
UDDS-Ortho-3-2024

Details and patient eligibility

About

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.

Full description

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.

Enrollment

41 patients

Sex

All

Ages

10 to 13 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  1. Previous orthodontic procedures.
  2. Systemic diseases.
  3. Temporal Mandibular Joint disorders.
  4. Poor oral hygiene

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

41 participants in 2 patient groups

Mini-implant-supported Twin-Block
Experimental group
Description:
Treatment will be done using the Mini-implant-supported Twin-block appliance until the correction is achieved.
Treatment:
Device: Mini-implant-supported Twin-Block
Conventional Twin-Block group
Active Comparator group
Description:
Treatment will be done using the Twin-block appliance until the correction is achieved.
Treatment:
Device: Twin-Block

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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