Orthodontic Appliance ComplicationNCT06403033
Mini-implant-supported Twin-Block in Treating Patients With Class II Division 1 Malocclusion
A study testing Mini-implant-supported Twin-Block and Twin-Block in people with Orthodontic Appliance Complication and Malocclusion, Angle Class II, Division 1, run by Damascus University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 13 years
- Conditions the study is for
- Orthodontic Appliance Complication, Malocclusion, Angle Class II, Division 1
- What is being tested?
- Mini-implant-supported Twin-Block and Twin-Block
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSyria
- Study dates
- 10 Sep 2022to 26 Dec 2023
- 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 10 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Previous orthodontic procedures.
- Systemic diseases.
- Temporal Mandibular Joint disorders.
- Poor oral hygiene
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Orthodontics, Faculty of Dentistry, University of Damsacus
Damascus, DM20 HAJ72
About this study
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
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.
Read the 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.
- Being tested
- Mini-implant-supported Twin-Block, Twin-Block
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-implant-supported Twin-BlockDevice
Mini-implants will support the Twin-Block appliance during the functional treatment.
Twin-BlockDevice
This is the main appliance that will be used to correct the Class II deformity.
| Study group | Role | What they receive |
|---|---|---|
| Mini-implant-supported Twin-Block | Experimental | Treatment will be done using the Mini-implant-supported Twin-block appliance until the correction is achieved. Receives: Device: Mini-implant-supported Twin-Block |
| Conventional Twin-Block group | Active comparator | Treatment will be done using the Twin-block appliance until the correction is achieved. Receives: Device: Twin-Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the overjet
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).
Measured: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the overbite
Lateral cephalometric images were taken for each patient. This was measured vertically from the upper to the lower central incisors' edges (in mm).
Measured: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the molar relationship
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).
Measured: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the position of the maxillary base
Lateral cephalometric images were taken for each patient. This was measured sagittally from A point to a vertical reference plane (in mm).
Measured: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the position of the mandibular base
Lateral cephalometric images were taken for each patient. This was measured sagittally from Pogonion Point to a vertical reference plane (in mm).
Measured: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the mandibular position relative to the upper jaw
Lateral cephalometric images were taken for each patient. This was measured sagittally from A point to Pogonion Point (in mm).
Measured: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in condylar head position
Lateral cephalometric images were taken for each patient. This was measured sagittally from Condylion point to the vertical reference plane (in mm).
Measured: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the composite mandibular length
Lateral cephalometric images were taken for each patient. This was measured sagittally from Condylion Point to the Pogonion Point (in mm).
Measured: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in position of the maxillary incisor
Lateral cephalometric images were taken for each patient. This was measured sagittally from the upper central incisor edge to the A Point (in mm).
Measured: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in position of the mandibular incisor
Lateral cephalometric images were taken for each patient. This was measured sagittally from the lower central incisor edge to the Pogonion Point (in mm).
Measured: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in position of the maxillary permanent first molar
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).
Measured: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in position of the mandibular permanent first molar
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).
Measured: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the ramus height
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.
Measured: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the corpus length
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.
Measured: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in MM angle
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.
Measured: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the SN-OP
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.
Measured: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the SN-MP
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.
Measured: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the Bjork sum (N-S-Ar + S-Ar-Go +Ar-Go-Me)
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).
Measured: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the inclination of the upper incisors.
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.
Measured: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Change in the L1-MP angle
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.
Measured: T0: One day before the beginning of the functional treatment, T1: After completing functional treatment which which is expected within 11 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start10 Sep 2022
- Primary completion27 Nov 2023
- Study completion26 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Appliance ComplicationStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rabea A Ghareeb, DDS, Principal investigator, Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, SyriaKinda Sultan, DDS MSc PhD, Study director, Department of Orthodontics, Faculty of Dentistry, Damascus UniversityMohammad Y Hajeer, DDS MSc PhD, Study chair, Department of Orthodontics, Faculty of Dentistry, Damascus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403033
- Sponsor's protocol ID
- UDDS-Ortho-3-2024
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdulhadi A, Burhan AS, Hajeer MY, Hamadah O, Mahmoud G, Nawaya FR, Namera MO. Evaluation of the Functional Treatment of Patients With Skeletal Class II Malocclusion Using Low-Level Laser Therapy-Assisted Twin-Block Appliance: A Three-Arm Randomized Controlled Trial. Cureus. 2022 Mar 24;14(3):e23449. doi: 10.7759/cureus.23449. eCollection 2022 Mar.
PubMed 35345811Burhan 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.
PubMed 25296729Tripathi T, Singh N, Rai P, Gupta P. Mini-implant-supported twin-block appliance: An innovative modification. Niger J Clin Pract. 2019 Mar;22(3):432-438. doi: 10.4103/njcp.njcp_342_18.
PubMed 30837435O'Brien K, Wright J, Conboy F, Sanjie Y, Mandall N, Chadwick S, Connolly I, Cook P, Birnie D, Hammond M, Harradine N, Lewis D, McDade C, Mitchell L, Murray A, O'Neill J, Read M, Robinson S, Roberts-Harry D, Sandler J, Shaw I. Effectiveness of early orthodontic treatment with the Twin-block appliance: a multicenter, randomized, controlled trial. Part 1: Dental and skeletal effects. Am J Orthod Dentofacial Orthop. 2003 Sep;124(3):234-43; quiz 339. doi: 10.1016/S0889540603003524.
PubMed 12970656Ehsani S, Nebbe B, Normando D, Lagravere MO, Flores-Mir C. Short-term treatment effects produced by the Twin-block appliance: a systematic review and meta-analysis. Eur J Orthod. 2015 Apr;37(2):170-6. doi: 10.1093/ejo/cju030. Epub 2014 Jul 22.
PubMed 25052373Ghareeb RA, Sultan K, Hajeer MY, Ajaj MA, Alzoubi H. Comparison of skeletal and dentoalveolar effects of mini-implant-supported twin block versus conventional twin block in treating growing patients with Class II Division 1 malocclusion: a two-arm randomized controlled clinical trial. Eur J Orthod. 2025 Oct 16;47(6):cjaf093. doi: 10.1093/ejo/cjaf093.
PubMed 41347939
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06403033
- Acronym / sponsor ID
- UDDS-Ortho-3-2024
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 10 Sep 2022 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 26 Dec 2023 (actual)
- First posted
- 7 May 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini-implant-supported Twin-Block | Experimental | Device: Mini-implant-supported Twin-BlockTreatment will be done using the Mini-implant-supported Twin-block appliance until the correction is achieved. |
| Conventional Twin-Block group | Active comparator | Device: Twin-BlockTreatment will be done using the Twin-block appliance until the correction is achieved. |
Who may qualify
- Ages
- 10 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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),
Key exclusion criteria (4 listed)
- Previous orthodontic procedures.
- Systemic diseases.
- Temporal Mandibular Joint disorders.
- Poor oral hygiene
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 |
|---|---|---|
| Mini-implant-supported Twin-BlockMini-implants will support the Twin-Block appliance during the functional treatment. | Device | Mini-implant-supported Twin-Block |
| Twin-BlockThis is the main appliance that will be used to correct the Class II deformity. | Device | Conventional Twin-Block group |
Primary outcome
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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).
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.
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.
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.
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.
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.
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).
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.
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.
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 9 May 2024.
- Background: PubMed 35345811Abdulhadi A, Burhan AS, Hajeer MY, Hamadah O, Mahmoud G, Nawaya FR, Namera MO. Evaluation of the Functional Treatment of Patients With Skeletal Class II Malocclusion Using Low-Level Laser Therapy-Assisted Twin-Block Appliance: A Three-Arm Randomized Controlled Trial. Cureus. 2022 Mar 24;14(3):e23449. doi: 10.7759/cureus.23449. eCollection 2022 Mar.
- Background: PubMed 25296729Burhan 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.
- Background: PubMed 30837435Tripathi T, Singh N, Rai P, Gupta P. Mini-implant-supported twin-block appliance: An innovative modification. Niger J Clin Pract. 2019 Mar;22(3):432-438. doi: 10.4103/njcp.njcp_342_18.
- Background: PubMed 12970656O'Brien K, Wright J, Conboy F, Sanjie Y, Mandall N, Chadwick S, Connolly I, Cook P, Birnie D, Hammond M, Harradine N, Lewis D, McDade C, Mitchell L, Murray A, O'Neill J, Read M, Robinson S, Roberts-Harry D, Sandler J, Shaw I. Effectiveness of early orthodontic treatment with the Twin-block appliance: a multicenter, randomized, controlled trial. Part 1: Dental and skeletal effects. Am J Orthod Dentofacial Orthop. 2003 Sep;124(3):234-43; quiz 339. doi: 10.1016/S0889540603003524.
- Background: PubMed 25052373Ehsani S, Nebbe B, Normando D, Lagravere MO, Flores-Mir C. Short-term treatment effects produced by the Twin-block appliance: a systematic review and meta-analysis. Eur J Orthod. 2015 Apr;37(2):170-6. doi: 10.1093/ejo/cju030. Epub 2014 Jul 22.
- Derived from this study: PubMed 41347939Ghareeb RA, Sultan K, Hajeer MY, Ajaj MA, Alzoubi H. Comparison of skeletal and dentoalveolar effects of mini-implant-supported twin block versus conventional twin block in treating growing patients with Class II Division 1 malocclusion: a two-arm randomized controlled clinical trial. Eur J Orthod. 2025 Oct 16;47(6):cjaf093. doi: 10.1093/ejo/cjaf093.
- Individual participant dataSharing planned: No
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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.
Rabea A Ghareeb, DDS principal investigator
Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
Kinda Sultan, DDS MSc PhD study director
Department of Orthodontics, Faculty of Dentistry, Damascus University
Mohammad Y Hajeer, DDS MSc PhD study chair
Department of Orthodontics, Faculty of Dentistry, Damascus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini-implant-supported Twin-Block and Twin-Block in people with Orthodontic Appliance Complication and Malocclusion, Angle Class II, Division 1, run by Damascus University at 1 site in Syria.
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 8 inclusion and 4 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 9 May 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 Syria. 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?
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.). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06403033, which also lists 6 linked publications.
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 9 May 2024.