Class III Malocclusion in Growing PatientsNCT02144324
Changes Following the Treatment of Lower Jaw Protrusion Using Two Appliances
A study testing Tandem Appliance in people with Class III Malocclusion in Growing Patients, run by Damascus University at 1 site in Syria.
Trial summary
An in vivo study evaluating the efficacy of the Tandem appliance in the treatment of maxillary deficiency in growing patients compared to the conventional facemask appliance treatment. Pre-treatment and post-treatment lateral cephalograms will be taken. Read more about this study
- Who is it for?
- Ages 8 to 10 years
- Conditions the study is for
- Class III Malocclusion in Growing Patients
- What is being tested?
- Tandem Appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSyria
- Study dates
- May 2014to Apr 2015
- 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 8 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Skeletal Class III (ANB angle < 0 degree) with due to maxillary retrusion, or a combination of maxillary retrusion and mandibular protrusion.
- Angle Class III malocclusion with an anterior crossbite.
- An optimum SN/GoGn angle (between 26 and 38 degrees).
- Fully erupted maxillary incisors.
Who cannot join
- Congenitally missing teeth or congenital syndromes such as a cleft lip/palate
- History of previous orthodontic treatment
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Orthodontics, University of Damascus Dental School
Damascus, Rif-dimashq Governorate, DM20AM18
About this study
Official title: A Comparison of the Skeletal and Dento-alveolar Changes After Treatment of Class III Malocclusion With a Modified Tandem Appliance Versus the Face Mask
An in vivo study evaluating the efficacy of the Tandem appliance in the treatment of maxillary deficiency in growing patients compared to the conventional facemask appliance treatment. Pre-treatment and post-treatment lateral cephalograms will be taken. Dentofacial, sagittal and vertical skeletal measurements will be taken at three assessment times. Changes within each group will be assessed. In addition, the changes between the two groups will be compared.
Read the detailed description
Maxillary deficiency or retrusion is generally accepted as one of the most difficult and complex orthodontic anomalies to diagnose and treat. Facemask therapy is usually preferred for the treatment of subjects with skeletal and dental Class III malocclusions with a retruded maxilla, and it is known that if the patient is sufficiently motivated to wear a facemask, this type of therapy is quite successful. patient compliance required during facemask therapy due to its poor aesthetics and intraoral appliances for Class III malocclusion treatment such as the Fränkel III , bionator III don't give treatment goals .Hybrid appliance tandem traction bow appliance (TTBA)is introduced by Chun et al. 1999 , as a more aesthetic, effective and comfortable device. Klempner, 2003 modified tandem appliance and published two case reports suggested that TTBA and modified applications have a similar treatment effect to that of an expander-facemask combination(2). A review of the literature showed that there were no statistical studies documenting the effects of modified tandem appliance comparing to traditional expander-facemask therapy and these are the investigators study purposes.
Study design: patients aged between 8-10 with anterior cross bite will be selected from orthodontic department in faculty of dentistry in Damascus university. Pretreatment cephalometric radiography will be taken. Subjects follow inclusion criteria (Skeletal Class III (ANB < 0 degree), due to maxillary retrusion, or a combination of maxillary retrusion and mandibular protrusion, Angle Class III malocclusion with an anterior crossbite., an optimum SN/GoGn angle between 26 and 38 degrees ,fully erupted maxillary incisors,,no congenitally missing teeth or congenital syndromes such as a cleft lip/palate will be . Patient will divided to two group tandem group and face mask group depended on growth pattern. Where from patients in face mask group have normal or horizontal growth pattern,tandem group have vertical one.
Appliance Design The Tandem Appliance comprises three separate components,two fixed and one removable. The upper section is a fixed McNamara expander with buccal arms soldered for attachment of protraction elastics. The lower section is consist of two bands with buccal headgear tubes and buccolingual welded arch for support . Third one is head-gear facebow inserted into the lower tubes and the outer bows bent out for elastics attachment. At the beginning of treatment, patients or Panther are instructed to wear the appliance with light, 8oz /14-16/ hours a day training elastics from the outer face-bow to the buccal arms of the upper expander. Subsequently, heavy orthopedic traction with 14oz /14-16/ hours a day,elastics effectively delivers the protraction force to the maxilla. Lateral cephalometric radiographs without the expander will be taken after a Class I molar relationship and a minimum overjet of 2 mm is obtained. Pre-treatment and post-treatment lateral cephalmetric dentofacial , sagittal and vertical skeletal parameters will be retraced by the author . Statistical analysis will be undertaken using the Statistical Package for Social Sciences, Windows version 19.0 (SPSS Inc., Chicago, Illinois, USA) Paired t-test will be used to evaluate the treatment effects and changes in same group. In depended t-test will be used to evaluate the treatment effects I between groups. confidence level 95% (P< 0.05).
- Being tested
- Tandem Appliance
- Keywords
- Maxillary protraction, Modified Tandem Appliance, Face mask therapy, Class III malocclusion, Maxillary deficiency
- Medical subject headings
- Malocclusion, Angle Class III, Retrognathia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tandem ApplianceDevice
We are going to use a modified version of the Tandem Appliance
| Study group | Role | What they receive |
|---|---|---|
| Tandem Appliance | Experimental | This group of patients will receive the new appliance which is called the Tandem Appliance Receives: Device: Tandem Appliance |
| Traditional Treatment | No intervention | Patients in this group will be treated by the traditional Face Mask appliance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the SNA angle
This variable is measured on the lateral cephalogram taken at two time points. This variable is used to give an information about the relative position of the upper jaw in relation to the anterior cranial base.
Measured: This variable will be measured twice: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment.
Change in the spatial position of Point A
Point A is defined as the point at the maximum concavity of the anterior upper alveolus (containing the upper incisors). The horizontal distance between Point A and the N-perpendicular will be also used to determine the antero-posterior positioning of Point A before and after treatment
Measured: This variable will be measured twice: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment.
Secondary outcomes (2)
Change in the SNB angle
B is a point located on the mandible on the lateral cephalogram This point is used to determine the antero-posterior positioning of the mandible (lower jaw).
Measured: This variable will be measured twice: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment.
Change in the overjet value
Overjet is defined as the horizontal overlap between the upper an lower anterior teeth. This variable is going to be measured twice in order to see the changes that occurred in each group antero-posteriorly as a result of the provided orthodontic appliance.
Measured: This variable will be measured twice: (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 posted22 May 2014 (estimated)
- Study startMay 2014
- Primary completionMar 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Class III Malocclusion in Growing PatientsStudies 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
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amro Husson, DDS, Principal investigator, MSc student, Department of Orthodontics, University of Damascus Dental SchoolAhamd Burhan, DDS MSc PhD, Study chair, Senior Lecturer in Orthodontics, University of Al-Baath Dental School, Hamah, Syria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02144324
- Sponsor's protocol ID
- UDDS-Ortho-01-2014
- Status last verified
- Apr 2015
- First submitted
- 16 May 2014
- Last updated
- 21 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Atalay Z, Tortop T. Dentofacial effects of a modified tandem traction bow appliance. Eur J Orthod. 2010 Dec;32(6):655-61. doi: 10.1093/ejo/cjp153. Epub 2010 Mar 26.
PubMed 20348164Chun YS, Jeong SG, Row J, Yang SJ. A new appliance for orthopedic correction of Class III malocclusion. J Clin Orthod. 1999 Dec;33(12):705-11. No abstract available.
PubMed 10895664Klempner LS. Early orthopedic Class III treatment with a modified tandem appliance. J Clin Orthod. 2003 Apr;37(4):218-23; quiz 204. No abstract available.
PubMed 12747076Klempner L. Early treatment of skeletal Class III open bite with the Tandem Appliance. J Clin Orthod. 2011 Jun;45(6):308-16; quiz 339. No abstract available.
PubMed 21778583Owens D, Watkinson S, Harrison JE, Turner S, Worthington HV. Orthodontic treatment for prominent lower front teeth (Class III malocclusion) in children. Cochrane Database Syst Rev. 2024 Apr 10;4(4):CD003451. doi: 10.1002/14651858.CD003451.pub3.
PubMed 38597341
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Skeletal and Dento-alveolar Changes After Treatment of Class III Malocclusion With a Modified Tandem Appliance Versus the Face Mask
- ClinicalTrials.gov ID
- NCT02144324
- Acronym / sponsor ID
- UDDS-Ortho-01-2014
- Keywords
- Maxillary protraction, Modified Tandem Appliance, Face mask therapy, Class III malocclusion, Maxillary deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 22 May 2014 (estimated)
- 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.
An in vivo study evaluating the efficacy of the Tandem appliance in the treatment of maxillary deficiency in growing patients compared to the conventional facemask appliance treatment. Pre-treatment and post-treatment lateral cephalograms will be taken. Dentofacial, sagittal and vertical skeletal measurements will be taken at three assessment times. Changes within each group will be assessed. In addition, the changes between the two groups will be compared.
Detailed description
Maxillary deficiency or retrusion is generally accepted as one of the most difficult and complex orthodontic anomalies to diagnose and treat. Facemask therapy is usually preferred for the treatment of subjects with skeletal and dental Class III malocclusions with a retruded maxilla, and it is known that if the patient is sufficiently motivated to wear a facemask, this type of therapy is quite successful. patient compliance required during facemask therapy due to its poor aesthetics and intraoral appliances for Class III malocclusion treatment such as the Fränkel III , bionator III don't give treatment goals .Hybrid appliance tandem traction bow appliance (TTBA)is introduced by Chun et al. 1999 , as a more aesthetic, effective and comfortable device. Klempner, 2003 modified tandem appliance and published two case reports suggested that TTBA and modified applications have a similar treatment effect to that of an expander-facemask combination(2). A review of the literature showed that there were no statistical studies documenting the effects of modified tandem appliance comparing to traditional expander-facemask therapy and these are the investigators study purposes.
Study design: patients aged between 8-10 with anterior cross bite will be selected from orthodontic department in faculty of dentistry in Damascus university. Pretreatment cephalometric radiography will be taken. Subjects follow inclusion criteria (Skeletal Class III (ANB < 0 degree), due to maxillary retrusion, or a combination of maxillary retrusion and mandibular protrusion, Angle Class III malocclusion with an anterior crossbite., an optimum SN/GoGn angle between 26 and 38 degrees ,fully erupted maxillary incisors,,no congenitally missing teeth or congenital syndromes such as a cleft lip/palate will be . Patient will divided to two group tandem group and face mask group depended on growth pattern. Where from patients in face mask group have normal or horizontal growth pattern,tandem group have vertical one.
Appliance Design The Tandem Appliance comprises three separate components,two fixed and one removable. The upper section is a fixed McNamara expander with buccal arms soldered for attachment of protraction elastics. The lower section is consist of two bands with buccal headgear tubes and buccolingual welded arch for support . Third one is head-gear facebow inserted into the lower tubes and the outer bows bent out for elastics attachment. At the beginning of treatment, patients or Panther are instructed to wear the appliance with light, 8oz /14-16/ hours a day training elastics from the outer face-bow to the buccal arms of the upper expander. Subsequently, heavy orthopedic traction with 14oz /14-16/ hours a day,elastics effectively delivers the protraction force to the maxilla. Lateral cephalometric radiographs without the expander will be taken after a Class I molar relationship and a minimum overjet of 2 mm is obtained. Pre-treatment and post-treatment lateral cephalmetric dentofacial , sagittal and vertical skeletal parameters will be retraced by the author . Statistical analysis will be undertaken using the Statistical Package for Social Sciences, Windows version 19.0 (SPSS Inc., Chicago, Illinois, USA) Paired t-test will be used to evaluate the treatment effects and changes in same group. In depended t-test will be used to evaluate the treatment effects I between groups. confidence level 95% (P< 0.05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tandem Appliance | Experimental | Device: Tandem ApplianceThis group of patients will receive the new appliance which is called the Tandem Appliance |
| Traditional Treatment | No intervention | –Patients in this group will be treated by the traditional Face Mask appliance. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Skeletal Class III (ANB angle < 0 degree) with due to maxillary retrusion, or a combination of maxillary retrusion and mandibular protrusion.
- Angle Class III malocclusion with an anterior crossbite.
- An optimum SN/GoGn angle (between 26 and 38 degrees).
- Fully erupted maxillary incisors.
Key exclusion criteria (2 listed)
- Congenitally missing teeth or congenital syndromes such as a cleft lip/palate
- 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 |
|---|---|---|
| Tandem ApplianceWe are going to use a modified version of the Tandem Appliance | Device | Tandem Appliance |
Primary outcome
Change in the SNA angle
Time frame: This variable will be measured twice: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment.
This variable is measured on the lateral cephalogram taken at two time points. This variable is used to give an information about the relative position of the upper jaw in relation to the anterior cranial base.
Change in the spatial position of Point A
Time frame: This variable will be measured twice: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment.
Point A is defined as the point at the maximum concavity of the anterior upper alveolus (containing the upper incisors). The horizontal distance between Point A and the N-perpendicular will be also used to determine the antero-posterior positioning of Point A before and after treatment
2 secondary outcomes
Change in the SNB angle
Time frame: This variable will be measured twice: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment.
Change in the overjet value
Time frame: This variable will be measured twice: (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 21 Apr 2015.
- Background: PubMed 20348164Atalay Z, Tortop T. Dentofacial effects of a modified tandem traction bow appliance. Eur J Orthod. 2010 Dec;32(6):655-61. doi: 10.1093/ejo/cjp153. Epub 2010 Mar 26.
- Background: PubMed 10895664Chun YS, Jeong SG, Row J, Yang SJ. A new appliance for orthopedic correction of Class III malocclusion. J Clin Orthod. 1999 Dec;33(12):705-11. No abstract available.
- Background: PubMed 12747076Klempner LS. Early orthopedic Class III treatment with a modified tandem appliance. J Clin Orthod. 2003 Apr;37(4):218-23; quiz 204. No abstract available.
- Background: PubMed 21778583Klempner L. Early treatment of skeletal Class III open bite with the Tandem Appliance. J Clin Orthod. 2011 Jun;45(6):308-16; quiz 339. No abstract available.
- Derived from this study: PubMed 38597341Owens D, Watkinson S, Harrison JE, Turner S, Worthington HV. Orthodontic treatment for prominent lower front teeth (Class III malocclusion) in children. Cochrane Database Syst Rev. 2024 Apr 10;4(4):CD003451. doi: 10.1002/14651858.CD003451.pub3.
Related trials for Class III Malocclusion in Growing Patients
Enrolling by invitation
Skeletal and Dentoalveolar Effects of Functional Clear Aligner Therapy in Growing Patient With Skeletal Class III Malocclusion
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Effects of Invisalign Palatal Expander vs Rapid Palatal Expander With Facemask in Growing Class III Patients
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Comparison of Maxillary Protraction Using Tooth-borne Facemask Versus Skeletal Anchorage Chin-plate in Class III Growing Patients
Skeletal Class III Malocclusion
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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.
Amro Husson, DDS principal investigator
MSc student, Department of Orthodontics, University of Damascus Dental School
Ahamd Burhan, DDS MSc PhD study chair
Senior Lecturer in Orthodontics, University of Al-Baath Dental School, Hamah, 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 Tandem Appliance in people with Class III Malocclusion in Growing Patients, 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 4 inclusion and 2 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 21 Apr 2015. 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 SNA angle (time frame: This variable will be measured twice: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment.). The study lists 2 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 NCT02144324, which also lists 5 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 21 Apr 2015.