Effects of Skeletal Anchored Versus Incisal Capped Twin Block Appliance in Class II Malocclusion

NCT06209086 | Completed

• 1 other identifier: Ortho
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

: the purpose of this study was to evaluate the dento-skeletal effects of the mini-implant supported Twin Block versus the incisal capped appliance in the treatment of skeletal class II patients with mandibular retrognathism. Methods: Twenty patients with skeletal class II mandibular retrusion were included in the study. They were recruited with a random and equal allocation into 2 groups. The first group was treated with incisal capped TB without skeletal anchorage. The second group were treated with mini-implant supported TB. The mini-implants were inserted in the inter-radicular region between the mandibular second premolar and first molar. Intra-oral elastics were attached from the mini-implant to the wire hook in the canine region of the lower part of the TB and they were changed every 24 hrs. 100 to 150 gm of force was applied. Cephalometric radiographs were acquired at the beginning (T1) and end of treatment (T2). The paired-samples and independent-samples t-tests were used to evaluate and compare the changes within groups and between groups, respectively.

Conditions

Class II Malocclusion

Outcome Measures

Primary Outcomes (1)

• dentoskeletal effects of skeletal anchored versus incisal capped twin block appliance in the correction of skeletal class II malocclusion

  the study include 20 patients with skeletal class II malocclusion who were treated with incisal capped and skeletal anchored twin block advancement of mandible with controlling the position of lower incisors in the second group

  11 months

Study Arms (2)

incisal capped twin block

ACTIVE COMPARATOR

The incisal capped Twin Block, which was used for the first group composed of two parts. The upper part had labial bow over labial surface of upper anterior teeth using Adam and ball clasps for retention. The lower part included ball clasp between lower anterior teeth and Adam clasp on lower first premolar with the additional modifications: * The lower incisors were capped with acryl. * lower incisors were relieved from the lingual side with wax.

Device: skeletal anchored twin block

skeletal anchored twin block

ACTIVE COMPARATOR

This appliance was constructed as the modified Twin Block used for the incisal capped appliance in addition to the following modifications: * Addition of mini-implants interdentally between the mandibular second premolar and mandibular first molar. * Wire hooks: wire hook element in the lower part of the appliance was incorporated in the region of incisal capping with free end projecting at the canine region on both sides. * Intra-oral elastics were attached from the mini-implant to the wire hook bilaterally.

Device: skeletal anchored twin block

Interventions

skeletal anchored twin block DEVICE

This appliance was constructed as the modified Twin Block used for the first group in addition to the following modifications: * Addition of mini-implants interdentally between the mandibular second premolar and mandibular first molar. * Wire hooks: wire hook element in the lower part of the appliance was incorporated in the region of incisal capping with free end projecting at the canine region on both sides. * Intra-oral elastics were attached from the mini-implant to the wire hook bilaterally.

incisal capped twin block; skeletal anchored twin block

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• early permanent dentition (ages 9 to 14)
• mandibular retrusion-related class II skeletal deformity
• overjet more than 4mm.

You may not qualify if:

• systemic diseases
• congenital craniofacial deformity
• cleft lip or palate
• unusual habits
• previous orthodontic treatment.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Dentistry

Al Mansurah, 35516, Egypt

Location

MeSH Terms

Conditions

Overbite

Condition Hierarchy (Ancestors)

Malocclusion, Angle Class II; Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Asmaa A Elabd, master

  mansoura univeristy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: teaching assistant - orthodontic department

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: January 17, 2024
• Study Start: May 12, 2021
• Primary Completion: May 25, 2022
• Study Completion: June 19, 2022
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)