Clinical trial NCT06403033: Mini-implant-supported Twin-Block in Treating Patients With Class II Division 1 Malocclusion
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Appliance Complication
Malocclusion, Angle Class II, Division 1
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 41
Sex: ALL
Minimum age (years): 10
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in the overjet
timeFrame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
measure: Change in the overbite
timeFrame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
measure: Change in the molar relationship
timeFrame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
measure: Change in the position of the maxillary base
timeFrame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
measure: Change in the position of the mandibular base
timeFrame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
measure: Change in the mandibular position relative to the upper jaw
timeFrame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
measure: Change in condylar head position
timeFrame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
measure: Change in the composite mandibular length
timeFrame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
measure: Change in position of the maxillary incisor
timeFrame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
measure: Change in position of the mandibular incisor
timeFrame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
measure: Change in position of the maxillary permanent first molar
timeFrame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
measure: Change in position of the mandibular permanent first molar
timeFrame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
measure: Change in the ramus height
timeFrame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
measure: Change in the corpus length
timeFrame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
measure: Change in MM angle
timeFrame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
measure: Change in the SN-OP
timeFrame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
measure: Change in the SN-MP
timeFrame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
measure: Change in the Bjork sum (N-S-Ar + S-Ar-Go +Ar-Go-Me)
timeFrame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
measure: Change in the inclination of the upper incisors.
timeFrame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
measure: Change in the L1-MP angle
timeFrame: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Department of Orthodontics, Faculty of Dentistry, University of Damsacus
Study officials:
affiliation: Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
name: Rabea A Ghareeb, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Orthodontics, Faculty of Dentistry, Damascus University
name: Kinda Sultan, DDS MSc PhD
role: STUDY_DIRECTOR
affiliation: Department of Orthodontics, Faculty of Dentistry, Damascus University
name: Mohammad Y Hajeer, DDS MSc PhD
role: STUDY_CHAIR
References:
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citation: Burhan AS, Nawaya FR. Dentoskeletal effects of the Bite-Jumping Appliance and the Twin-Block Appliance in the treatment of skeletal Class II malocclusion: a randomized controlled trial. Eur J Orthod. 2015 Jun;37(3):330-7. doi: 10.1093/ejo/cju052. Epub 2014 Oct 8.
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