Evaluation of Mini Plates Anchorage With Forsus Fatigue Resistant Device
NCT ID: NCT02475785
Last Updated: 2017-07-21
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
48 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-01-31
Study Completion Date
2016-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The purpose of this study is to determine if the Forsus Fatigue resistant Device appliance with direct skeletal mini plates anchorage is capable of achievement of skeletal mandibular effects while preventing the excessive proclination of the lower incisors at the end of the treatment when compared to the conventional Forsus Fatigue resistant Device appliance applied to the upper and lower dental arches in female patients with skeletal Class II malocclusion
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Skeletally Versus Dentally Anchored Herbst Appliance
NCT04402164
Angle Class II, Division 1
COMPLETED
NA
Effectiveness of Two Skeletally Anchored Force Mechanics for Skeletal Class II Correction in Growing Patients
NCT04884022
Malocclusion
UNKNOWN
NA
Comparison Between Mini Implant Supported Appliance and Headgear in Treatment of Maxillary Excess in Growing Patients
NCT03839303
Class II Division 1 Malocclusion
UNKNOWN
NA
Mandibular First Molar Distalization
NCT04229797
Class III Malocclusion
NOT_YET_RECRUITING
NA
the Condylar Response of Mini-plate Anchored Rigid Fixed Functional Appliance Versus Dentally Anchored Semi-rigid One
NCT05466344
Class II Malocclusion
COMPLETED
PHASE2/PHASE3
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. Background:
Class II malocclusions are characterized by an incorrect relationship between the maxillary and mandibular arches due to skeletal or dental problems or a combination of both. The prevalence of this malocclusion was recently found to be 20.6% in the Egyptian population in the age between 11 and 14 years with mandibular retrusion as its most common characteristic. It was also mentioned that other populations showed the predominance of the mandibular retrusion (80%) as opposed to only 20% expressing excessive maxillary development.
Class II profiles attractiveness was previously investigated in the literature. It was found that patients, their peers, orthodontists and oral surgeons, rated subjects with Class I profiles as more attractive than others with Class II profiles. It was also reported that the profile of normal adolescent patients were more favorably perceived by laypersons than untreated Class II division 1 malocclusion subjects.
In growing patients having Class II mandibular retrusion, functional orthopedic appliances are commonly used for mandibular advancement based on the concept of growth modification. However, two main problems appeared to compromise the desired treatment outcomes of these appliances; the need for patient cooperation and the lack of the possibility of combining their use with fixed appliance therapy in order to shorten treatment duration.
Many systematic reviews and meta-analyses were recently performed in the literature answering the question of whether removable functional appliances (RFAs) produced skeletal effects for correction the skeletal discrepancy through inducing actual increase in mandibular dimensions. Most recently two systematic reviews concluded that the skeletal effects of RFAs were minimal and could be considered of negligible clinical importance. They mentioned that treatment of Class II malocclusion with RFAs was associated with a minimal stimulation of mandibular growth, a minimal restriction of maxillary growth and more significant dento-alveolar and soft tissue changes.
Fixed functional appliances were first introduced by Emil Herbst in 1905. Many types of fixed functional appliances were developed since then; including Jasper jumper and Twin force Bite corrector . The Forsus Fatigue Resistant Device (FFRD) was introduced by Bill Vogt in 2006. It represented a semi-rigid fixed functional alternative that was intended to overcome breakage problems of flexible fixed functional appliances. However, it was proven that dental changes were more significant than skeletal changes in the final occlusal results. These changes included mesial movement of the mandibular molars and proclination of the mandibular incisors. These unwanted tooth movements appeared to compromise the actual skeletal correction and jeopardize the stability of the results.
Several attempts were proposed to counteract the unwanted dento-alveolar side effects of fixed functional appliances. Use of lingual arches, increase the dimensions of the archwires, the introduction of negative torque in the archwires and the use of lower incisor brackets with lingual crown torque are some examples. Some studies used the mini implants in an attempt to limit the unwanted dental effects of fixed functional appliances. These studies proved that mini implants anchorage reduced the lower incisors proclination but they in turn increased the upper incisors retroclination and were not able to achieve significant skeletal mandibular effects.
Titanium mini plates were introduced for the use for orthodontic anchorage in 1999 as a skeletal anchorage system for open bite correction. They were proven to be well accepted by patients and providers, safe and effective adjunct for complex orthodontic cases. Other uses of mini plates in orthodontics included maxillary and mandibular molars distalization and orthodontic anchorage where it was reported that they were able to provide absolute anchorage. Bone anchored maxillary protraction using mini plates was reported to be successful in producing significant forward maxillary growth in Class III growing subjects. Recently mini plates were used for the direct loading of FFRD for correction of skeletal Class II malocclusion. They reported actual skeletal changes through the increase in the mandibular length with minimal dento-alveolar side effects. However, these results are only preliminary and have to be taken with caution because the study did not include control group.
2. Research Hypothesis:
The null hypothesis (H0) of this research is that use of direct mini plate anchorage in conjunction with FFRD will not be able to induce skeletal rather than dental effects for correction of the skeletal Class II malocclusion in comparison with conventional FFRD therapy or with untreated growing Class II control subjects.
3. Objectives:
The primary objective of this study is to determine if mini plates use in conjunction with FFRD will induce supplemental growth of the mandible in Class II malocclusion subjects with mandibular retrognathism.
Secondary objectives include
To determine if mini plates use in conjunction with FFRD will be able to:
* Reduce the dento-alveolar side effects produced by fixed functional appliances in treatment of skeletal Class II subjects
* Correct the soft tissue convexity in Class II subjects
* Correct molar and canines relationships
* Develop a patients' well-accepted treatment modality for correction of skeletal Class II malocclusion.
4. Study design
According to the norms of the CONSORT STATEMENT, this study will be clinical with intervention, in which the allocation of the subjects will be randomized (block randomization). This study will be parallel with blinding for the outcome assessors. The primary purpose of this study will be treatment.
5. Participants - Settings and locations where the data are collected
The treatment will be performed in the outpatient clinics of Department of Orthodontics of Cairo State University. This public university predominantly serves low-income population living in Cairo, Egypt. Data will be collected from April 2015 through August 2016.
6. Interventions
Two groups will receive treatment. Group 1 will be treated with the FFRD and mini plates anchorage for 10 months or until the correction of the malocclusion . Group 2 will be treated with conventional FFRD for 10 months or until the correction of the malocclusion. A third untreated control group will be included with an observation period of 6-8 months.
7a. Sample size
Our sample size calculation is based on a study which compared the use of Herbst appliance with and without mini implants anchorage and reported a significant increase in the Herbst mini screw group over their control group. The mean change in the mandibular length in the treatment and control groups were 4.6±2.43 mm and 0.9±2.09 mm respectively. Thus the mean difference was 3.7 with the within group standard deviation set at 2.26.
Because three groups will be compared, Bonferroni adjustment was used as alpha level/number of comparisons = 0.05/3= 0.0167 to adjust for multiple comparisons.
Power and Sample size calculation (PS) software (department of biostatistics Vanderbilt University) was used for sample size calculation. A t test was performed with the power was set as 0.9, allocation ratio of 1:1:1 and the Type I error probability (alpha) associated with this test was set as 0.0167. Results of the test showed that "The Group sample sizes of 11, 11 and 11 achieve 90% power to reject the null hypothesis of equal means with a significance level (alpha) of 0.0167"
Therefore, 33 subjects will be needed, with 11 subjects in each group. To account for patient loss to follow up (attrition), a sample size of 48 patients will be selected and divided into three groups, sixteen each.
7b. Interim analysis and stopping guidelines
In the group with mini plates anchorage, in case of mobility in the mini-plates in any subject, the load will be removed for about two weeks. After that, the load will be restored. If the mobility persists, surgical exposure of the mini plate will be done and either insertion of longer mini screws ion the same mini plate or a change in the position of the mini plate will be done.
Any harms, adverse effects or unintended effects of the study intervention will be documented and reported. Post-surgical swelling and pain are anticipated and will be addressed by antibiotics and pain killers. Other unanticipated surgical harms have to be immediately managed and will be reported. Harms related to the orthodontic appliances will be managed by the principal investigator.
8\. Randomization
8a. Sequence generation
The randomization of the recruited subjects will be done with a randomized list, using random.org website. This list is made by an individual not involved in the clinical trial (S.B.)
8b. Type
The type of randomization will be block randomization. The number of blocks and block sizes will be blinded to the investigators.
9\. Allocation and concealment mechanism
* Each patient will be allocated a number from sequentially numbered opaque sealed envelopes after fulfillment of the inclusion criteria and signing the informed consent to be enrolled in the study.
* According to the number, the patients will be then allocated into one of the groups using a randomization table.
10\. Implementation
Before the beginning of the research, the allocation sequence will be generated by a person not involved in the study (Dr S.B.). The random list will be sealed from the principal investigator who will enroll participants. After the participant takes a sealed number, S.B. will be contacted to implement the allocation. All the study contributors will have no access to the random list. The envelopes will be closed with the type of treatment selected for storage of the information.
11\. Blinding
Blinding will be carried out only for the data assessment because the researchers, participants and subjects can not be blinded. Therefore, a person who does not know the nature of the trial will analyze the data.
Class II malocclusions are characterized by an incorrect relationship between the maxillary and mandibular arches due to skeletal or dental problems or a combination of both. The prevalence of this malocclusion was recently found to be 20.6% in the Egyptian population in the age between 11 and 14 years with mandibular retrusion as its most common characteristic. It was also mentioned that other populations showed the predominance of the mandibular retrusion (80%) as opposed to only 20% expressing excessive maxillary development.
Class II profiles attractiveness was previously investigated in the literature. It was found that patients, their peers, orthodontists and oral surgeons, rated subjects with Class I profiles as more attractive than others with Class II profiles. It was also reported that the profile of normal adolescent patients were more favorably perceived by laypersons than untreated Class II division 1 malocclusion subjects.
In growing patients having Class II mandibular retrusion, functional orthopedic appliances are commonly used for mandibular advancement based on the concept of growth modification. However, two main problems appeared to compromise the desired treatment outcomes of these appliances; the need for patient cooperation and the lack of the possibility of combining their use with fixed appliance therapy in order to shorten treatment duration.
Many systematic reviews and meta-analyses were recently performed in the literature answering the question of whether removable functional appliances (RFAs) produced skeletal effects for correction the skeletal discrepancy through inducing actual increase in mandibular dimensions. Most recently two systematic reviews concluded that the skeletal effects of RFAs were minimal and could be considered of negligible clinical importance. They mentioned that treatment of Class II malocclusion with RFAs was associated with a minimal stimulation of mandibular growth, a minimal restriction of maxillary growth and more significant dento-alveolar and soft tissue changes.
Fixed functional appliances were first introduced by Emil Herbst in 1905. Many types of fixed functional appliances were developed since then; including Jasper jumper and Twin force Bite corrector . The Forsus Fatigue Resistant Device (FFRD) was introduced by Bill Vogt in 2006. It represented a semi-rigid fixed functional alternative that was intended to overcome breakage problems of flexible fixed functional appliances. However, it was proven that dental changes were more significant than skeletal changes in the final occlusal results. These changes included mesial movement of the mandibular molars and proclination of the mandibular incisors. These unwanted tooth movements appeared to compromise the actual skeletal correction and jeopardize the stability of the results.
Several attempts were proposed to counteract the unwanted dento-alveolar side effects of fixed functional appliances. Use of lingual arches, increase the dimensions of the archwires, the introduction of negative torque in the archwires and the use of lower incisor brackets with lingual crown torque are some examples. Some studies used the mini implants in an attempt to limit the unwanted dental effects of fixed functional appliances. These studies proved that mini implants anchorage reduced the lower incisors proclination but they in turn increased the upper incisors retroclination and were not able to achieve significant skeletal mandibular effects.
Titanium mini plates were introduced for the use for orthodontic anchorage in 1999 as a skeletal anchorage system for open bite correction. They were proven to be well accepted by patients and providers, safe and effective adjunct for complex orthodontic cases. Other uses of mini plates in orthodontics included maxillary and mandibular molars distalization and orthodontic anchorage where it was reported that they were able to provide absolute anchorage. Bone anchored maxillary protraction using mini plates was reported to be successful in producing significant forward maxillary growth in Class III growing subjects. Recently mini plates were used for the direct loading of FFRD for correction of skeletal Class II malocclusion. They reported actual skeletal changes through the increase in the mandibular length with minimal dento-alveolar side effects. However, these results are only preliminary and have to be taken with caution because the study did not include control group.
2. Research Hypothesis:
The null hypothesis (H0) of this research is that use of direct mini plate anchorage in conjunction with FFRD will not be able to induce skeletal rather than dental effects for correction of the skeletal Class II malocclusion in comparison with conventional FFRD therapy or with untreated growing Class II control subjects.
3. Objectives:
The primary objective of this study is to determine if mini plates use in conjunction with FFRD will induce supplemental growth of the mandible in Class II malocclusion subjects with mandibular retrognathism.
Secondary objectives include
To determine if mini plates use in conjunction with FFRD will be able to:
* Reduce the dento-alveolar side effects produced by fixed functional appliances in treatment of skeletal Class II subjects
* Correct the soft tissue convexity in Class II subjects
* Correct molar and canines relationships
* Develop a patients' well-accepted treatment modality for correction of skeletal Class II malocclusion.
4. Study design
According to the norms of the CONSORT STATEMENT, this study will be clinical with intervention, in which the allocation of the subjects will be randomized (block randomization). This study will be parallel with blinding for the outcome assessors. The primary purpose of this study will be treatment.
5. Participants - Settings and locations where the data are collected
The treatment will be performed in the outpatient clinics of Department of Orthodontics of Cairo State University. This public university predominantly serves low-income population living in Cairo, Egypt. Data will be collected from April 2015 through August 2016.
6. Interventions
Two groups will receive treatment. Group 1 will be treated with the FFRD and mini plates anchorage for 10 months or until the correction of the malocclusion . Group 2 will be treated with conventional FFRD for 10 months or until the correction of the malocclusion. A third untreated control group will be included with an observation period of 6-8 months.
7a. Sample size
Our sample size calculation is based on a study which compared the use of Herbst appliance with and without mini implants anchorage and reported a significant increase in the Herbst mini screw group over their control group. The mean change in the mandibular length in the treatment and control groups were 4.6±2.43 mm and 0.9±2.09 mm respectively. Thus the mean difference was 3.7 with the within group standard deviation set at 2.26.
Because three groups will be compared, Bonferroni adjustment was used as alpha level/number of comparisons = 0.05/3= 0.0167 to adjust for multiple comparisons.
Power and Sample size calculation (PS) software (department of biostatistics Vanderbilt University) was used for sample size calculation. A t test was performed with the power was set as 0.9, allocation ratio of 1:1:1 and the Type I error probability (alpha) associated with this test was set as 0.0167. Results of the test showed that "The Group sample sizes of 11, 11 and 11 achieve 90% power to reject the null hypothesis of equal means with a significance level (alpha) of 0.0167"
Therefore, 33 subjects will be needed, with 11 subjects in each group. To account for patient loss to follow up (attrition), a sample size of 48 patients will be selected and divided into three groups, sixteen each.
7b. Interim analysis and stopping guidelines
In the group with mini plates anchorage, in case of mobility in the mini-plates in any subject, the load will be removed for about two weeks. After that, the load will be restored. If the mobility persists, surgical exposure of the mini plate will be done and either insertion of longer mini screws ion the same mini plate or a change in the position of the mini plate will be done.
Any harms, adverse effects or unintended effects of the study intervention will be documented and reported. Post-surgical swelling and pain are anticipated and will be addressed by antibiotics and pain killers. Other unanticipated surgical harms have to be immediately managed and will be reported. Harms related to the orthodontic appliances will be managed by the principal investigator.
8\. Randomization
8a. Sequence generation
The randomization of the recruited subjects will be done with a randomized list, using random.org website. This list is made by an individual not involved in the clinical trial (S.B.)
8b. Type
The type of randomization will be block randomization. The number of blocks and block sizes will be blinded to the investigators.
9\. Allocation and concealment mechanism
* Each patient will be allocated a number from sequentially numbered opaque sealed envelopes after fulfillment of the inclusion criteria and signing the informed consent to be enrolled in the study.
* According to the number, the patients will be then allocated into one of the groups using a randomization table.
10\. Implementation
Before the beginning of the research, the allocation sequence will be generated by a person not involved in the study (Dr S.B.). The random list will be sealed from the principal investigator who will enroll participants. After the participant takes a sealed number, S.B. will be contacted to implement the allocation. All the study contributors will have no access to the random list. The envelopes will be closed with the type of treatment selected for storage of the information.
11\. Blinding
Blinding will be carried out only for the data assessment because the researchers, participants and subjects can not be blinded. Therefore, a person who does not know the nature of the trial will analyze the data.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Malocclusion, Angle Class II, Division 1
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
FFRD and mini plates group
Upper will be bonded, levelled and aligned until reaching 0.019 x 0.025 ss archwires.
2 Y shaped mini plates will be inserted in the mandibular symphysis Insertion of the FFRD with Direct application over the mandibular mini plates
Group Type
EXPERIMENTAL
FFRD and mini plates group
Intervention Type
DEVICE
FFRD direct loading over mini plates inserted in the mandibular symphysis
conventional FFRD
Upper and lower arches will be bonded, levelled and aligned until reaching 0.019 x 0.025 ss archwires.
Insertion of FFRD with application over the lower archwire
Group Type
ACTIVE_COMPARATOR
Conventional FFRD
Intervention Type
DEVICE
FFRD inserted between maxillary and mandibular arches with the pushrods placed distal to mandibular canines
untreated control group
Patients will be observed for an average duration of 6-8 months
Group Type
NO_INTERVENTION
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FFRD and mini plates group
FFRD direct loading over mini plates inserted in the mandibular symphysis
Intervention Type
DEVICE
Conventional FFRD
FFRD inserted between maxillary and mandibular arches with the pushrods placed distal to mandibular canines
Intervention Type
DEVICE
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Mini plates anchored FFRD
Dental anchored FFRD
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Skeletal Angle Class II division 1 malocclusion with a deficient mandible. (SNB ≤ 76°)
* Horizontal or neutral growth pattern. (MMP ≤ 30°)
* Increased overjet (min 5 mm) with Class II canine relationship. (minimum of half unit)
* Mandibular arch crowding less than 3 mm.
* At the time of insertion of the FFRD, the patients had to be in the "Middle Phalanx of the Middle finger" stage G or H (MP3 G or MP3 H stage) according to Rajagopal.
* Horizontal or neutral growth pattern. (MMP ≤ 30°)
* Increased overjet (min 5 mm) with Class II canine relationship. (minimum of half unit)
* Mandibular arch crowding less than 3 mm.
* At the time of insertion of the FFRD, the patients had to be in the "Middle Phalanx of the Middle finger" stage G or H (MP3 G or MP3 H stage) according to Rajagopal.
Exclusion Criteria
* Systemic Disease.
* Any signs or symptoms or previous history of temporomandibular disorders (TMD) as clicking, crepitus, pain, limitation or deviation.
* Extracted or missing upper permanent tooth/teeth (except for third molars).
* Facial Asymmetry.
* Para-functional habits.
* Severe proclination or crowding that requires extractions in the lower arch.
* Any signs or symptoms or previous history of temporomandibular disorders (TMD) as clicking, crepitus, pain, limitation or deviation.
* Extracted or missing upper permanent tooth/teeth (except for third molars).
* Facial Asymmetry.
* Para-functional habits.
* Severe proclination or crowding that requires extractions in the lower arch.
Minimum Eligible Age
10 Years
Maximum Eligible Age
13 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sherif A. Elkordy
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sherif A. Elkordy
Dr
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sherif Elkordy, Phd
Role: PRINCIPAL_INVESTIGATOR
Associate Lecturer of Orthodontics Cairo University
Amr Abouelezz, MSc
Role: STUDY_CHAIR
Professor of Orthodontics Cairo University
Mona Fayed, Phd
Role: STUDY_DIRECTOR
Associate Professor of Orthodontics Cairo University
Mai Abou el Fotouh, Phd
Role: STUDY_DIRECTOR
Lecturer of Orthodontics Cairo University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Orthodontic department, Faculty of Oral and Dental Medicine, Cairo University
Cairo, , Egypt
Site Status
Countries
Review the countries where the study has at least one active or historical site.
Egypt
References
Explore related publications, articles, or registry entries linked to this study.
Pancherz H. Treatment of class II malocclusions by jumping the bite with the Herbst appliance. A cephalometric investigation. Am J Orthod. 1979 Oct;76(4):423-42. doi: 10.1016/0002-9416(79)90227-6.
Reference Type
BACKGROUND
Pancherz H, Hansen K. Occlusal changes during and after Herbst treatment: a cephalometric investigation. Eur J Orthod. 1986 Nov;8(4):215-28. doi: 10.1093/ejo/8.4.215. No abstract available.
Reference Type
BACKGROUND
Sugawara J, Daimaruya T, Umemori M, Nagasaka H, Takahashi I, Kawamura H, Mitani H. Distal movement of mandibular molars in adult patients with the skeletal anchorage system. Am J Orthod Dentofacial Orthop. 2004 Feb;125(2):130-8. doi: 10.1016/j.ajodo.2003.02.003.
Reference Type
BACKGROUND
Umemori M, Sugawara J, Mitani H, Nagasaka H, Kawamura H. Skeletal anchorage system for open-bite correction. Am J Orthod Dentofacial Orthop. 1999 Feb;115(2):166-74. doi: 10.1016/S0889-5406(99)70345-8.
Reference Type
BACKGROUND
Celikoglu M, Unal T, Bayram M, Candirli C. Treatment of a skeletal Class II malocclusion using fixed functional appliance with miniplate anchorage. Eur J Dent. 2014 Apr;8(2):276-280. doi: 10.4103/1305-7456.130637.
Reference Type
BACKGROUND
Unal T, Celikoglu M, Candirli C. Evaluation of the effects of skeletal anchoraged Forsus FRD using miniplates inserted on mandibular symphysis: A new approach for the treatment of Class II malocclusion. Angle Orthod. 2015 May;85(3):413-9. doi: 10.2319/051314-345.1. Epub 2014 Oct 3.
Reference Type
BACKGROUND
Elkordy SA, Abouelezz AM, Fayed MM, Attia KH, Ishaq RA, Mostafa YA. Three-dimensional effects of the mini-implant-anchored Forsus Fatigue Resistant Device: A randomized controlled trial. Angle Orthod. 2016 Mar;86(2):292-305. doi: 10.2319/012515-55.1. Epub 2015 May 19.
Reference Type
BACKGROUND
Aslan BI, Kucukkaraca E, Turkoz C, Dincer M. Treatment effects of the Forsus Fatigue Resistant Device used with miniscrew anchorage. Angle Orthod. 2014 Jan;84(1):76-87. doi: 10.2319/032613-240.1. Epub 2013 Jun 17.
Reference Type
BACKGROUND
Phillips C, Griffin T, Bennett E. Perception of facial attractiveness by patients, peers, and professionals. Int J Adult Orthodon Orthognath Surg. 1995;10(2):127-35.
Reference Type
BACKGROUND
Bishara SE, Jakobsen JR. Profile changes in patients treated with and without extractions: assessments by lay people. Am J Orthod Dentofacial Orthop. 1997 Dec;112(6):639-44. doi: 10.1016/s0889-5406(97)70229-4.
Reference Type
BACKGROUND
El-Mangoury NH, Mostafa YA. Epidemiologic panorama of dental occlusion. Angle Orthod. 1990 Fall;60(3):207-14. doi: 10.1043/0003-3219(1990)0602.0.CO;2.
Reference Type
BACKGROUND
Tulloch JF, Proffit WR, Phillips C. Outcomes in a 2-phase randomized clinical trial of early Class II treatment. Am J Orthod Dentofacial Orthop. 2004 Jun;125(6):657-67. doi: 10.1016/j.ajodo.2004.02.008.
Reference Type
BACKGROUND
Koretsi V, Zymperdikas VF, Papageorgiou SN, Papadopoulos MA. Treatment effects of removable functional appliances in patients with Class II malocclusion: a systematic review and meta-analysis. Eur J Orthod. 2015 Aug;37(4):418-34. doi: 10.1093/ejo/cju071. Epub 2014 Nov 13.
Reference Type
BACKGROUND
Vogt W. The Forsus Fatigue Resistant Device. J Clin Orthod. 2006 Jun;40(6):368-77; quiz 358. No abstract available.
Reference Type
BACKGROUND
Heinig N, Goz G. Clinical application and effects of the Forsus spring. A study of a new Herbst hybrid. J Orofac Orthop. 2001 Nov;62(6):436-50. doi: 10.1007/s00056-001-0053-6. English, German.
Reference Type
BACKGROUND
Luzi C, Luzi V, Melsen B. Mini-implants and the efficiency of Herbst treatment: a preliminary study. Prog Orthod. 2013 Jul 31;14:21. doi: 10.1186/2196-1042-14-21.
Reference Type
BACKGROUND
Luzi C, Luzi V. [Skeletal Class II treatment with the miniscrew-anchored Herbst]. Orthod Fr. 2013 Dec;84(4):307-18. doi: 10.1051/orthodfr/2013070. Epub 2013 Nov 27. French.
Reference Type
BACKGROUND
Cornelis MA, Scheffler NR, Nyssen-Behets C, De Clerck HJ, Tulloch JF. Patients' and orthodontists' perceptions of miniplates used for temporary skeletal anchorage: a prospective study. Am J Orthod Dentofacial Orthop. 2008 Jan;133(1):18-24. doi: 10.1016/j.ajodo.2006.09.049.
Reference Type
BACKGROUND
De Clerck H, Cevidanes L, Baccetti T. Dentofacial effects of bone-anchored maxillary protraction: a controlled study of consecutively treated Class III patients. Am J Orthod Dentofacial Orthop. 2010 Nov;138(5):577-81. doi: 10.1016/j.ajodo.2009.10.037.
Reference Type
BACKGROUND
Kim S, Herring S, Wang IC, Alcalde R, Mak V, Fu I, Huang G. A comparison of miniplates and teeth for orthodontic anchorage. Am J Orthod Dentofacial Orthop. 2008 Feb;133(2):189.e1-9. doi: 10.1016/j.ajodo.2007.07.016.
Reference Type
BACKGROUND
Rajagopal R, Kansal S. A comparison of modified MP3 stages and the cervical vertebrae as growth indicators. J Clin Orthod. 2002 Jul;36(7):398-406. No abstract available.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CU001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Dentoskeletal Effects of 3D-Printed Fixed Twin Block Versus MARA Appliances in Management of Skeletal Class II
NCT07340242
RECRUITING
NA
Class II Malocclusion Correction Using the Mini-screw Supported Advanced Molar Distalization Appliance
NCT06726694
COMPLETED
NA
Assessment of Dentoskeletal Changes After Treatment of Skeletal classII by Twinblock Versus Monoblock Appliances
NCT07277543
COMPLETED
NA
Comparison Between Aesthetic Functional Appliances and Twin Block in Correction of Skeletal Class II
NCT06631235
NOT_YET_RECRUITING
NA
the Mini-plate Anchored Herbst Appliance Versus the Dentally Anchored Fixed Functional Appliance
NCT05440526
COMPLETED
PHASE2/PHASE3
Evaluation of Micro-osteoperforation on Rate of Maxillary En-masse Retraction
NCT03764189
UNKNOWN
NA
Measuring Rate of Anteriors Retraction With Two Different Techniques
NCT05542745
COMPLETED
NA
Effects of Skeletal Anchored Versus Incisal Capped Twin Block Appliance in Class II Malocclusion
NCT06209086
COMPLETED
NA
Treatment of Class III Malocclusion Using Modified Fixed Mandibular Retractor Appliance
NCT03354442
COMPLETED
NA
Evaluation Of Anchorage Control During Canine Retraction Using Arch Wire Stopper Versus Mini-Screws
NCT06416904
RECRUITING
NA
"Three Dimensional Assessment of Maxillary Molars Following Distalization Using Two Different Approaches"
NCT06240923
COMPLETED
NA
Mini-implant-supported Twin-Block in Treating Patients With Class II Division 1 Malocclusion
NCT06403033
COMPLETED
NA
Evaluation of the Effects of Flat and Modified Inclined Fixed Anterior Bite Planes on Mandibular Position in Growing Females With Skeletal Class 2 Malocclusion Due to Mandibular Deficiency and Deep Bite
NCT03308175
UNKNOWN
NA
Posterior Segment Intrusion Using Miniplates
NCT02674191
UNKNOWN
NA
Accuracy of Maxillary Fixation Using Custom Plates on Nasal Buttress Only Via Minimally Invasive Approach Versus Custom Plates on Nasal and Zygomatic Buttresses Via Conventional Approach in Orthognathic Surgeries
NCT07311785
NOT_YET_RECRUITING
NA
En Masse Distaliaztion Via Skeletal Anchorage
NCT05245929
UNKNOWN
NA
Evaluation of Skeletal and Dental Effect of the New Hybrid Aesthetic Functional Appliance
NCT06209125
COMPLETED
NA
Effects of the Herbst Appliance With Different Anchorages and Twin-Block Appliance in Class II Malocclusion
NCT02411812
ACTIVE_NOT_RECRUITING
NA
Comparison of Two Miniscrew Anchored Maxillary Protraction Protocols
NCT03712007
COMPLETED
NA
Effects of Orthopedic Mandibular Advancement in Class II Division 1 Malocclusion on Pharyngeal Airway
NCT04255511
COMPLETED
NA
Effects of Modified Fixed Twin Block Versus Removable Twin Block on Skeletal Class 2 Growing Patients With Mandibular Deficiency
NCT05993156
UNKNOWN
NA
Evaluation of 3D Printed Modified Twin Block for Correction of Skeletal Class II Malocclusion in Growing Females
NCT04028661
UNKNOWN
NA
Friction Versus Frictionless Mechanics During Maxillary En-masse Retraction in Adult Patients
NCT03261024
UNKNOWN
NA
Evaluation of Dentoalveolar Changes of Clear Aligners Versus Fixed Orthodontic Appliances on Skeletal Class I Non-extraction Patients With Dental Crowding
NCT07090746
ACTIVE_NOT_RECRUITING
NA
Distalization by Miniscrew
NCT02427282
COMPLETED
PHASE1