Class III MalocclusionNCT05350306
The Effects of the Chin Cup on Temporomandibular Joint and Mandibular Dimensions
A study testing Chincup in people with Class III Malocclusion, run by Damascus University at 1 site in Syria.
Trial summary
This in vivo comparative study will evaluate the changes in the mandibular dimensions and the glenoid fossa after skeletal class III subjects' therapy by chincup appliance and compare it with an untreated class III control group. Read more about this study
- Who is it for?
- Ages 6 to 8 years
- Conditions the study is for
- Class III Malocclusion
- What is being tested?
- Chincup
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSyria
- Study dates
- 1 Jan 2019to 1 Apr 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 6 to 8 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Clinical Inclusion criteria:
- Children ages 6-8 years with anterior crossbite or edge-to-edge incisor relationship.
- Class III relationships of the permanent first molars or mesial step relationships of the primary second molars.
- the absence of centric relation and maximum intercuspation discrepancy
- short-face pattern, adequate overbite.
- Radiological Inclusion criteria:
- Mild to moderate skeletal class III (4- <the sagittal skeletal angle (ANB)< 0 degree), due to mandibular protrusion (SNB > 80°).
- normal or horizontal growth pattern (Bjork's sum ≤396° ±5°)
Who cannot join
- temporomandibular joint disorders
- craniofacial anomalies
- history of previous orthodontic treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Dimensional Changes in the Mandible, Condyles, and the Temporomandibular Joint Following Skeletal Class III Treatment With the Chin Cup Using Low-Dose Computed Tomography
This in vivo comparative study will evaluate the changes in the mandibular dimensions and the glenoid fossa after skeletal class III subjects' therapy by chincup appliance and compare it with an untreated class III control group. Pre and post-treatment low-dose computed tomography images will be taken before and after achieving positive overjet and undergoing 16 months of active treatment/ observation. Dimensional and volumetric changes in the mandible, condyles, and glenoid fossa will be calculated and compared to those observed in the control group.
Read the detailed description
Chincup is a usual treatment strategy for growing subjects with skeletal Class III malocclusions due to the mandibular overgrowth. However, the review of the literature reveals controversies and contradictions regarding the efficacy of chincup therapy in the retardation of mandibular growth. Moreover, the adaption of the temporomandibular joint (TMJ) following this treatment isn't clear yet. Two recent systematic reviews recommended the need for high-quality studies.
Computed tomography has been considered an ideal tool for evaluating the TMJ with the possibility of determining the real dimensions of the structures under study. Low-dose computed tomography was introduced as an alternative procedure with an effective dose proximately equal to traditional radiographs. Moreover, the volumetric analysis afforded by 3D imaging has proven reliable and accurate in the evaluation of mandibular and condylar sizes. Therefore, the objective of this randomized control trial is to evaluate the dimensional changes in the mandible, condyles, and glenoid fossa after chin cup therapy for children with mandibular prognathism in comparison with untreated Class III patients
Methods: patients ages between 6 and 8 with anterior crossbite, Class III relationships of the permanent first molars or mesial step relationships of the primary second molars, and short-faced pattern, will be selected from the orthodontic department in the faculty of dentistry at Damascus university. Thirty-eight subjects will be enrolled on the study, who will meet the following radiological inclusion criteria based on cephalometric images: Mild to moderate skeletal class III (4- <the sagittal skeletal angle< 0 degree), due to mandibular protrusion (SNB > 80°), and normal or horizontal growth pattern (Bjork's sum ≤396° ±5°).
Patients in the experimental group will receive an individual fabricated bonded bite block and occipital chincup. A 400-500g/side retroactive force will be applied in the direction of the condyles. Patients or panthers will be instructed to wear the appliance /14-16/ hours a day. Pre-(T1) and post-treatment (T2) low-dose computed tomography images will be taken after a positive overjet of 2-4 mm is obtained and undergoing 16 months of active treatment/ observation. The changes in condyle-mandibular volumes and superficial areas and relative positions of the condyles and glenoid fossa will be calculated and compared with those of untreated. Statistical analysis will be done by using the Statistical Package for Social Sciences, Windows version 26.0 (SPSS Inc., Chicago, Illinois, USA) Paired t-test and Wilcoxon signed-rank tests will be used for intragroup comparisons. For the intergroup comparisons, independent t-tests and Mann-Whitney U tests will be carried out.The confidence level is 95% (P< 0.05).
- Conditions
- Class III Malocclusion
- Being tested
- Chincup, Control group
- Keywords
- chin cup, low-dose computed tomography, condyle-mandibular dimensions
- Medical subject headings
- Malocclusion, Angle Class III
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChincupDevice
Patients will receive an individual fabricated bonded bite block and occipital chincup. A 400-500g/side retroactive force will be applied in the direction of the condyles. Patients or panthers will be instructed to wear the appliance /14-16/ hours a day.
Control groupOther
The changes in condyle-mandibular volumes and superficial areas and relative positions of the condyles and glenoid fossa will be calculated after 16 months of observation.
| Study group | Role | What they receive |
|---|---|---|
| Chincup | Experimental | Patients will be treated with occipital chincup and bonded bite block. Receives: Device: Chincup |
| Untreated subjects | Active comparator | Patients will not undergone any treatment for 16 months. Receives: Other: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the mandibular volume and superficial area
After a semiautomatic segmentation will be utilized to isolate the mandibular bone, the mandible will be rendered in high-quality 3D model. Then, the crowns of the teeth will be removed by a plane passing through 1 mm inferior to the alveolar bone and 10 mm distal to the second primary molars. The mandible volumes and surface sizes will be automatically calculated by the software in mm3 and mm2, respectively.
Measured: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Changes in the condylar volume and superficial area
The condyles will be cut from 3D rendered mandibular model at neck level using a plane parallel to the Frankfort horizontal plane at the most inferior part of the sigmoid notch, the condyle volumes and surface sizes will be automatically calculated by the software in mm3 and mm2, respectively.
Measured: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Change in the mandibular body (Go-Gn)
Distance between the Gonion point and the Gnathion point.
Measured: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Change in the ramus height (Co-Go)
Distance between the Condylion point and the Gonion point.
Measured: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Change in the total body length (Co-Gn)
Distance between the Condylion point and the Gnathion point.
Measured: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Change in the mandibular angle (GN-Go-CO)
The angle between the Condylion point, the Gonion point and Gnathion point.
Measured: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Change in the vertical position of the condyle (CP-FH)
The measurement will be made on the corrected sagittal view: Distance of Condylar posterior point from Frankfort horizontal plane.
Measured: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Change in the sagittal position of the condyle (CP-Y)
The measurement will be made on the corrected sagittal view: Distance of Condylar posterior point from Perpendicular plane (Y).
Measured: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
change in the vertical position of the mandibular fossa (FP-FH)
The measurement will be made on the corrected sagittal view: Distance of Fossa posterior point from Frankfort horizontal plane (FH).
Measured: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Change in the sagittal position of the mandibular fossa (FP-Y)
The measurement will be made on the corrected sagittal view: Distance of point Fossa posterior point from Perpendicular plane (Y).
Measured: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Quantitative changes of displacement of superimposed 3D mode
The T1 and T2 3D volumes will be superimposed manually followed by automatic global registration. The point-based analysis will be performed to assess the changes in 3D mandibular models between T1 and T2, and a colour map will be produced. Quantitative mean, minimum, and maximum values of part analyses will be reported for comparative analyses.
Measured: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Secondary outcomes (3)
Change in the anterior joint space (AJS)
The measurement will be made on the corrected sagittal view: Distance between Condylar anterior point and Fossa anterior point.
Measured: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Chang in the superior joint space (SJS)
The measurements will be made on the corrected sagittal view: Distance between Condylar posterior point and Fossa superior point.
Measured: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Chang in the posterior joint space (PJS)
The measurements will be made on the corrected sagittal view: Distance between Condylar posterior point and Fossa posterior point.
Measured: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Jan 2019
- Primary completion1 Jan 2022
- Study completion1 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Class III MalocclusionStudies 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amr H Husson, DDS,MSc,PhD, Principal investigator, Department of orthodontics, Damascus University, SyriaMohammad Y Hajeer, DDS,MSc,PhD, Study director, Department of orthodontics, Damascus University, SyriaAhamd S Burhan, DDS,MSc,PhD, Study director, Department of orthodontics, Damascus University, SyriaFehmieh R Nawaya, DDS,MSc,PhD, Study director, Department of orthodontics, Damascus University, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05350306
- Sponsor's protocol ID
- UDDS-Ortho-09-2022
- Status last verified
- Apr 2022
- First submitted
- 22 Apr 2022
- Last updated
- 4 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chatzoudi MI, Ioannidou-Marathiotou I, Papadopoulos MA. Clinical effectiveness of chin cup treatment for the management of Class III malocclusion in pre-pubertal patients: a systematic review and meta-analysis. Prog Orthod. 2014 Dec 2;15(1):62. doi: 10.1186/s40510-014-0062-9.
PubMed 25679781Liu ZP, Li CJ, Hu HK, Chen JW, Li F, Zou SJ. Efficacy of short-term chincup therapy for mandibular growth retardation in Class III malocclusion. Angle Orthod. 2011 Jan;81(1):162-68. doi: 10.2319/050510-244.1.
PubMed 20936970Zurfluh MA, Kloukos D, Patcas R, Eliades T. Effect of chin-cup treatment on the temporomandibular joint: a systematic review. Eur J Orthod. 2015 Jun;37(3):314-24. doi: 10.1093/ejo/cju048. Epub 2014 Sep 1.
PubMed 25179261Swennen GR, Schutyser F. Three-dimensional cephalometry: spiral multi-slice vs cone-beam computed tomography. Am J Orthod Dentofacial Orthop. 2006 Sep;130(3):410-6. doi: 10.1016/j.ajodo.2005.11.035.
PubMed 16979502Lo Giudice A, Ronsivalle V, Grippaudo C, Lucchese A, Muraglie S, Lagravere MO, Isola G. One Step before 3D Printing-Evaluation of Imaging Software Accuracy for 3-Dimensional Analysis of the Mandible: A Comparative Study Using a Surface-to-Surface Matching Technique. Materials (Basel). 2020 Jun 21;13(12):2798. doi: 10.3390/ma13122798.
PubMed 32575875Cordasco G, Portelli M, Militi A, Nucera R, Lo Giudice A, Gatto E, Lucchese A. Low-dose protocol of the spiral CT in orthodontics: comparative evaluation of entrance skin dose with traditional X-ray techniques. Prog Orthod. 2013 Sep 10;14:24. doi: 10.1186/2196-1042-14-24.
PubMed 24325970Ikeda K, Kawamura A. Assessment of optimal condylar position with limited cone-beam computed tomography. Am J Orthod Dentofacial Orthop. 2009 Apr;135(4):495-501. doi: 10.1016/j.ajodo.2007.05.021.
PubMed 19361736Husson AH, Burhan AS, Hajeer MY, Nawaya FR. Evaluation of the dimensional changes in the mandible, condyles, and the temporomandibular joint following skeletal class III treatment with chin cup and bonded maxillary bite block using low-dose computed tomography: A single-center, randomized controlled trial. F1000Res. 2023 Mar 13;12:264. doi: 10.12688/f1000research.130941.1. eCollection 2023.
PubMed 37008891
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Dimensional Changes in the Mandible, Condyles, and the Temporomandibular Joint Following Skeletal Class III Treatment With the Chin Cup Using Low-Dose Computed Tomography
- ClinicalTrials.gov ID
- NCT05350306
- Acronym / sponsor ID
- UDDS-Ortho-09-2022
- Conditions
- Class III Malocclusion
- Keywords
- chin cup, low-dose computed tomography, condyle-mandibular dimensions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Apr 2022 (actual)
- First posted
- 28 Apr 2022 (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.
This in vivo comparative study will evaluate the changes in the mandibular dimensions and the glenoid fossa after skeletal class III subjects' therapy by chincup appliance and compare it with an untreated class III control group. Pre and post-treatment low-dose computed tomography images will be taken before and after achieving positive overjet and undergoing 16 months of active treatment/ observation. Dimensional and volumetric changes in the mandible, condyles, and glenoid fossa will be calculated and compared to those observed in the control group.
Detailed description
Chincup is a usual treatment strategy for growing subjects with skeletal Class III malocclusions due to the mandibular overgrowth. However, the review of the literature reveals controversies and contradictions regarding the efficacy of chincup therapy in the retardation of mandibular growth. Moreover, the adaption of the temporomandibular joint (TMJ) following this treatment isn't clear yet. Two recent systematic reviews recommended the need for high-quality studies.
Computed tomography has been considered an ideal tool for evaluating the TMJ with the possibility of determining the real dimensions of the structures under study. Low-dose computed tomography was introduced as an alternative procedure with an effective dose proximately equal to traditional radiographs. Moreover, the volumetric analysis afforded by 3D imaging has proven reliable and accurate in the evaluation of mandibular and condylar sizes. Therefore, the objective of this randomized control trial is to evaluate the dimensional changes in the mandible, condyles, and glenoid fossa after chin cup therapy for children with mandibular prognathism in comparison with untreated Class III patients
Methods: patients ages between 6 and 8 with anterior crossbite, Class III relationships of the permanent first molars or mesial step relationships of the primary second molars, and short-faced pattern, will be selected from the orthodontic department in the faculty of dentistry at Damascus university. Thirty-eight subjects will be enrolled on the study, who will meet the following radiological inclusion criteria based on cephalometric images: Mild to moderate skeletal class III (4- <the sagittal skeletal angle< 0 degree), due to mandibular protrusion (SNB > 80°), and normal or horizontal growth pattern (Bjork's sum ≤396° ±5°).
Patients in the experimental group will receive an individual fabricated bonded bite block and occipital chincup. A 400-500g/side retroactive force will be applied in the direction of the condyles. Patients or panthers will be instructed to wear the appliance /14-16/ hours a day. Pre-(T1) and post-treatment (T2) low-dose computed tomography images will be taken after a positive overjet of 2-4 mm is obtained and undergoing 16 months of active treatment/ observation. The changes in condyle-mandibular volumes and superficial areas and relative positions of the condyles and glenoid fossa will be calculated and compared with those of untreated. Statistical analysis will be done by using the Statistical Package for Social Sciences, Windows version 26.0 (SPSS Inc., Chicago, Illinois, USA) Paired t-test and Wilcoxon signed-rank tests will be used for intragroup comparisons. For the intergroup comparisons, independent t-tests and Mann-Whitney U tests will be carried out.The confidence level is 95% (P< 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chincup | Experimental | Device: ChincupPatients will be treated with occipital chincup and bonded bite block. |
| Untreated subjects | Active comparator | Other: Control groupPatients will not undergone any treatment for 16 months. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Children ages 6-8 years with anterior crossbite or edge-to-edge incisor relationship.
- Class III relationships of the permanent first molars or mesial step relationships of the primary second molars.
- the absence of centric relation and maximum intercuspation discrepancy
- short-face pattern, adequate overbite.
- Mild to moderate skeletal class III (4- <the sagittal skeletal angle (ANB)< 0 degree), due to mandibular protrusion (SNB > 80°).
Key exclusion criteria (3 listed)
- temporomandibular joint disorders
- craniofacial anomalies
- history of 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 |
|---|---|---|
| ChincupPatients will receive an individual fabricated bonded bite block and occipital chincup. A 400-500g/side retroactive force will be applied in the direction of the condyles. Patients or panthers will be instructed to wear the appliance /14-16/ hours a day. | Device | Chincup |
| Control groupThe changes in condyle-mandibular volumes and superficial areas and relative positions of the condyles and glenoid fossa will be calculated after 16 months of observation. | Other | Untreated subjects |
Primary outcome
Change in the mandibular volume and superficial area
Time frame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
After a semiautomatic segmentation will be utilized to isolate the mandibular bone, the mandible will be rendered in high-quality 3D model. Then, the crowns of the teeth will be removed by a plane passing through 1 mm inferior to the alveolar bone and 10 mm distal to the second primary molars. The mandible volumes and surface sizes will be automatically calculated by the software in mm3 and mm2, respectively.
Changes in the condylar volume and superficial area
Time frame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
The condyles will be cut from 3D rendered mandibular model at neck level using a plane parallel to the Frankfort horizontal plane at the most inferior part of the sigmoid notch, the condyle volumes and surface sizes will be automatically calculated by the software in mm3 and mm2, respectively.
Change in the mandibular body (Go-Gn)
Time frame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Distance between the Gonion point and the Gnathion point.
Change in the ramus height (Co-Go)
Time frame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Distance between the Condylion point and the Gonion point.
Change in the total body length (Co-Gn)
Time frame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Distance between the Condylion point and the Gnathion point.
Change in the mandibular angle (GN-Go-CO)
Time frame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
The angle between the Condylion point, the Gonion point and Gnathion point.
Change in the vertical position of the condyle (CP-FH)
Time frame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
The measurement will be made on the corrected sagittal view: Distance of Condylar posterior point from Frankfort horizontal plane.
Change in the sagittal position of the condyle (CP-Y)
Time frame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
The measurement will be made on the corrected sagittal view: Distance of Condylar posterior point from Perpendicular plane (Y).
change in the vertical position of the mandibular fossa (FP-FH)
Time frame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
The measurement will be made on the corrected sagittal view: Distance of Fossa posterior point from Frankfort horizontal plane (FH).
Change in the sagittal position of the mandibular fossa (FP-Y)
Time frame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
The measurement will be made on the corrected sagittal view: Distance of point Fossa posterior point from Perpendicular plane (Y).
Quantitative changes of displacement of superimposed 3D mode
Time frame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
The T1 and T2 3D volumes will be superimposed manually followed by automatic global registration. The point-based analysis will be performed to assess the changes in 3D mandibular models between T1 and T2, and a colour map will be produced. Quantitative mean, minimum, and maximum values of part analyses will be reported for comparative analyses.
3 secondary outcomes
Change in the anterior joint space (AJS)
Time frame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Chang in the superior joint space (SJS)
Time frame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
Chang in the posterior joint space (PJS)
Time frame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment
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 4 May 2022.
- Background: PubMed 25679781Chatzoudi MI, Ioannidou-Marathiotou I, Papadopoulos MA. Clinical effectiveness of chin cup treatment for the management of Class III malocclusion in pre-pubertal patients: a systematic review and meta-analysis. Prog Orthod. 2014 Dec 2;15(1):62. doi: 10.1186/s40510-014-0062-9.
- Background: PubMed 20936970Liu ZP, Li CJ, Hu HK, Chen JW, Li F, Zou SJ. Efficacy of short-term chincup therapy for mandibular growth retardation in Class III malocclusion. Angle Orthod. 2011 Jan;81(1):162-68. doi: 10.2319/050510-244.1.
- Background: PubMed 25179261Zurfluh MA, Kloukos D, Patcas R, Eliades T. Effect of chin-cup treatment on the temporomandibular joint: a systematic review. Eur J Orthod. 2015 Jun;37(3):314-24. doi: 10.1093/ejo/cju048. Epub 2014 Sep 1.
- Background: PubMed 16979502Swennen GR, Schutyser F. Three-dimensional cephalometry: spiral multi-slice vs cone-beam computed tomography. Am J Orthod Dentofacial Orthop. 2006 Sep;130(3):410-6. doi: 10.1016/j.ajodo.2005.11.035.
- Background: PubMed 32575875Lo Giudice A, Ronsivalle V, Grippaudo C, Lucchese A, Muraglie S, Lagravere MO, Isola G. One Step before 3D Printing-Evaluation of Imaging Software Accuracy for 3-Dimensional Analysis of the Mandible: A Comparative Study Using a Surface-to-Surface Matching Technique. Materials (Basel). 2020 Jun 21;13(12):2798. doi: 10.3390/ma13122798.
- Background: PubMed 24325970Cordasco G, Portelli M, Militi A, Nucera R, Lo Giudice A, Gatto E, Lucchese A. Low-dose protocol of the spiral CT in orthodontics: comparative evaluation of entrance skin dose with traditional X-ray techniques. Prog Orthod. 2013 Sep 10;14:24. doi: 10.1186/2196-1042-14-24.
- Background: PubMed 19361736Ikeda K, Kawamura A. Assessment of optimal condylar position with limited cone-beam computed tomography. Am J Orthod Dentofacial Orthop. 2009 Apr;135(4):495-501. doi: 10.1016/j.ajodo.2007.05.021.
- Derived from this study: PubMed 37008891Husson AH, Burhan AS, Hajeer MY, Nawaya FR. Evaluation of the dimensional changes in the mandible, condyles, and the temporomandibular joint following skeletal class III treatment with chin cup and bonded maxillary bite block using low-dose computed tomography: A single-center, randomized controlled trial. F1000Res. 2023 Mar 13;12:264. doi: 10.12688/f1000research.130941.1. eCollection 2023.
- 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.
Amr H Husson, DDS,MSc,PhD principal investigator
Department of orthodontics, Damascus University, Syria
Mohammad Y Hajeer, DDS,MSc,PhD study director
Department of orthodontics, Damascus University, Syria
Ahamd S Burhan, DDS,MSc,PhD study director
Department of orthodontics, Damascus University, Syria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chincup in people with Class III Malocclusion, 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 3 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 4 May 2022. 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 mandibular volume and superficial area (time frame: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment). The study lists 11 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 NCT05350306, which also lists 8 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 4 May 2022.