Class II MalocclusionNCT06209086
Effects of Skeletal Anchored Versus Incisal Capped Twin Block Appliance in Class II Malocclusion
A study testing skeletal anchored twin block in people with Class II Malocclusion, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Class II Malocclusion
- What is being tested?
- skeletal anchored twin block
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteEgypt
- Study dates
- 12 May 2021to 19 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- early permanent dentition (ages 9 to 14)
- mandibular retrusion-related class II skeletal deformity
- overjet more than 4mm.
Who cannot join
- systemic diseases
- congenital craniofacial deformity
- cleft lip or palate
- unusual habits
- previous orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Dentoskeletal Effects of Skeletal Anchored Versus Incisal Capped Twin Block Appliance in the Treatment of Class II Malocclusion
: 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.
Read the detailed description
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
Appliance construction:
- Bite registration
- First, the administrator measured the overjet using calibrated poly gauge from the incisal edge of the most protruded upper incisor to the facial surface of the lower central incisor.
- Then, a wax bite was done using the Exacto bite or Projet Bite Gauge (12) with the addition of softened horseshoe wafer of medium hard wax for easy registration of the bite. The mandible was anteriorly positioned to make an edge-to-edge relationship parallel to the functional occlusal plane. At the same time, the posterior vertical separation between arches was with an adequate width between 4-5 mm. The excess was removed along the gingiva, retromolar region and on the palatal tissue if found.
- During bite registration, making sure the upper and lower mid lines of the patient were the same as in his original distal occlusion as long as there was no functional shift of the mandible.
- Design of the appliance A-modified twin block 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. B-Mini-implant supported modified Twin Block .
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.
Insertion of the Mini-implants:
- Two orthodontic Dentaurum miniscrew (1,6*8 mm) were used in this study which were intended to be placed bilaterally on lower arch between the mandibular second premolar and first molar.
- Surgical mesh was used as a guide tool in the mouth for accurate placement of the mini- implants. The mesh guide was first adapted on the cast of each patient and it was extended from the mesial contact of the lower second premolar to the distal one of the first permanent molar and extended apically to the depth of the sulcus. Then it was tried in the patient mouth to avoid any extension that might cause injury to the oral mucosa of the patient.
- The mesh was then stabilized on the patient mouth by using rubber base impression material .
- Then peri apical radiographs were taken to use it as a guide for the precise placement of the mini-implant .
- The purpose of using rubber base material to ensure the accurate position of the mesh guide to be the same during the insertion of the mini screw intra orally.
- After locating the precise point of insertion of the mini-implant with the help of mesh guide and before the insertion of them, the mini-implants were self-drilled using a straight screwdriver in the attached gingiva at the mucogingival line leaving 0.5 mm of the transmucosal collar outside the mucosa. This amount of collar outside was planned to facilitate the insertion of intra oral elastics. The implants were inserted at approximately 20-30 degrees to the occlusal plane.
- Peri apical radiograph was then taken to the right and left sides to verify the position of mini-implant with the cone of the machine is directed perpendicular to the film .
- Intra oral elastics: elastics of dimension 3⁄8 (4 oz., 150 gm of force) was attached to the wire hooks to exert a class I distalizing force taking anchorage from mini-implants. The force is measured using Morelli force gauge.
Delivery of appliance and patient instruction:
The appliance was checked for fitting in the patient's mouth systemically, in the upper jaw then in the lower jaw separately and then the two parts were checked together when the jaws were closed. We checked the presence of any roughness, sharp areas or undercuts that may cause discomfort to the patients.
The patients and parents were instructed to:
- Put on the twin block appliance full time 24 hours a day.
- Maintain good oral hygiene, brush teeth and the appliance after each meal.
- Attain orthodontic clinic every three weeks.
- Change the elastics every 24 hour.
- Accordingly, at each appointment, the patient was checked for the outcomes of mandibular advancement and presence or absence of posterior cross-bite and subsequent need for opening of the expansion screw.
- At the time of activation, another registration wax bite was taken in this time for edge to edge upper and lower incisors.
Retention When the overjet was corrected; a retention appliance was constructed to correct lateral open bite that resulted from presence of occlusal bite blocks.
- Conditions
- Class II Malocclusion
- Being tested
- skeletal anchored twin block
- Medical subject headings
- Overbite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skeletal anchored twin blockDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: skeletal anchored twin block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start12 May 2021
- Primary completion25 May 2022
- Study completion19 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II MalocclusionStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Elabd, Mansoura University
- Investigators
- Asmaa A Elabd, master, Principal investigator, mansoura univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06209086
- Sponsor's protocol ID
- Ortho
- Status last verified
- Jan 2024
- First submitted
- 6 Jan 2024
- Last updated
- 22 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Dentoskeletal Effects of Skeletal Anchored Versus Incisal Capped Twin Block Appliance in the Treatment of Class II Malocclusion
- ClinicalTrials.gov ID
- NCT06209086
- Acronym / sponsor ID
- Ortho
- Conditions
- Class II Malocclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 12 May 2021 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 19 Jun 2022 (actual)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
: 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.
Detailed description
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
Appliance construction:
- Bite registration
- First, the administrator measured the overjet using calibrated poly gauge from the incisal edge of the most protruded upper incisor to the facial surface of the lower central incisor.
- Then, a wax bite was done using the Exacto bite or Projet Bite Gauge (12) with the addition of softened horseshoe wafer of medium hard wax for easy registration of the bite. The mandible was anteriorly positioned to make an edge-to-edge relationship parallel to the functional occlusal plane. At the same time, the posterior vertical separation between arches was with an adequate width between 4-5 mm. The excess was removed along the gingiva, retromolar region and on the palatal tissue if found.
- During bite registration, making sure the upper and lower mid lines of the patient were the same as in his original distal occlusion as long as there was no functional shift of the mandible.
- Design of the appliance A-modified twin block 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. B-Mini-implant supported modified Twin Block .
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.
Insertion of the Mini-implants:
- Two orthodontic Dentaurum miniscrew (1,6*8 mm) were used in this study which were intended to be placed bilaterally on lower arch between the mandibular second premolar and first molar.
- Surgical mesh was used as a guide tool in the mouth for accurate placement of the mini- implants. The mesh guide was first adapted on the cast of each patient and it was extended from the mesial contact of the lower second premolar to the distal one of the first permanent molar and extended apically to the depth of the sulcus. Then it was tried in the patient mouth to avoid any extension that might cause injury to the oral mucosa of the patient.
- The mesh was then stabilized on the patient mouth by using rubber base impression material .
- Then peri apical radiographs were taken to use it as a guide for the precise placement of the mini-implant .
- The purpose of using rubber base material to ensure the accurate position of the mesh guide to be the same during the insertion of the mini screw intra orally.
- After locating the precise point of insertion of the mini-implant with the help of mesh guide and before the insertion of them, the mini-implants were self-drilled using a straight screwdriver in the attached gingiva at the mucogingival line leaving 0.5 mm of the transmucosal collar outside the mucosa. This amount of collar outside was planned to facilitate the insertion of intra oral elastics. The implants were inserted at approximately 20-30 degrees to the occlusal plane.
- Peri apical radiograph was then taken to the right and left sides to verify the position of mini-implant with the cone of the machine is directed perpendicular to the film .
- Intra oral elastics: elastics of dimension 3⁄8 (4 oz., 150 gm of force) was attached to the wire hooks to exert a class I distalizing force taking anchorage from mini-implants. The force is measured using Morelli force gauge.
Delivery of appliance and patient instruction:
The appliance was checked for fitting in the patient's mouth systemically, in the upper jaw then in the lower jaw separately and then the two parts were checked together when the jaws were closed. We checked the presence of any roughness, sharp areas or undercuts that may cause discomfort to the patients.
The patients and parents were instructed to:
- Put on the twin block appliance full time 24 hours a day.
- Maintain good oral hygiene, brush teeth and the appliance after each meal.
- Attain orthodontic clinic every three weeks.
- Change the elastics every 24 hour.
- Accordingly, at each appointment, the patient was checked for the outcomes of mandibular advancement and presence or absence of posterior cross-bite and subsequent need for opening of the expansion screw.
- At the time of activation, another registration wax bite was taken in this time for edge to edge upper and lower incisors.
Retention When the overjet was corrected; a retention appliance was constructed to correct lateral open bite that resulted from presence of occlusal bite blocks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| incisal capped twin block | Active comparator | Device: skeletal anchored twin blockThe 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. |
| skeletal anchored twin block | Active comparator | Device: skeletal anchored twin blockThis 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. |
Who may qualify
- Ages
- 9 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- early permanent dentition (ages 9 to 14)
- mandibular retrusion-related class II skeletal deformity
- overjet more than 4mm.
Key exclusion criteria (5 listed)
- systemic diseases
- congenital craniofacial deformity
- cleft lip or palate
- unusual habits
- previous orthodontic treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skeletal anchored twin blockThis 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. | Device | incisal capped twin block, skeletal anchored twin block |
Primary outcome
dentoskeletal effects of skeletal anchored versus incisal capped twin block appliance in the correction of skeletal class II malocclusion
Time frame: 11 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Class II Malocclusion
Enrolling by invitation
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Maxillary Arch Distalization With Infrazygomatic Crest Miniscrews for Class II Malocclusion
Class II Malocclusion
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Comparing 3D-Printed and Milled Titanium Plates in Jaw Surgery (Le Fort I): Accuracy and Operative Time
Malocclusion, Angle Class II, Malocclusion, Angle Class III
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Treatment of Mild Class II Malocclusion in Adult Patients With Clear Aligners Versus Fixed Multibracket Therapy
Malocclusion, Class II Malocclusion
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Patient-Reported Outcomes for Different Orthodontic Thermoplastics Used in Clear Aligners
Malocclusion of Anterior Teeth, Malocclusion in Children
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asmaa A Elabd, master principal investigator
mansoura univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skeletal anchored twin block in people with Class II Malocclusion, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dentoskeletal effects of skeletal anchored versus incisal capped twin block appliance in the correction of skeletal class II malocclusion (time frame: 11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2024.