Class II Division 1 MalocclusionNCT04619446
Dentoskeletal Changes Produced by Growth Modification Appliances in Treatment of Skeletal Class II Malocclusion
An observational study of Class II Division 1 Malocclusion and Mandibular Retrognathism, run by Dr. Fareena Ghaffar at 1 site in Pakistan.
Trial summary
To compare dentoskeletal changes in patients with skeletal class II malocclusion induced due to treatment with orthodontic appliances; removable twin block appliance and fixed AdvanSync2 appliance in two different age group patients. Read more about this study
- Who is it for?
- Ages 9 to 15 years
- Conditions the study is for
- Class II Division 1 Malocclusion, Mandibular Retrognathism
- What is being tested?
- Removable Twin Block and Fixed Functional , AdvanSync Appliance
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 12 Sep 2020to 1 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: A.F.I.D, Rawalpindi. Thirty patients ( 15 between cervical vertebral maturation (CVM) stage of 2-3 to be treated with removable functional applianc and remaining 15 between CVM stage of 4-5 to be treated with fixed functional appliance) with skeletal class II malocclusion, presented at the department of Armed forces institute of dentistry (AFID).
Who may be able to join
- Class II div 1 malocclusion with mandible being placed backwards (SNB angle <78o)
- Convex facial profile
- ANB angle to be >4 degree
- overall good oral health
- no previous orthodontic treatment being done
- peak of pubertal growth at the start of treatment
Who cannot join
- Subjects presenting with any developmental defects
- Asymmetrical facial profile
- Impacted / missing / supernumerary or transposed teeth
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Armed Forces Institute of Dentistry (AFID)
Rawalpindi, Punjab Province, 44000
About this study
Official title: Dentoskeletal Changes of Twin Block Appliance and AdvanSync2 Appliance in Treatment of Skeletal Class II Malocclusion
To compare dentoskeletal changes in patients with skeletal class II malocclusion induced due to treatment with orthodontic appliances; removable twin block appliance and fixed AdvanSync2 appliance in two different age group patients.
Read the detailed description
41% of total orthodontic cases in Pakistani population are of class II malocclusion. Class II malocclusion is referred as maxillary protrusion, or mandibular retrusion, or combination of both, which can be corrected by treating the skeletal and dento-alveolar discrepancies. Out of many recommended treatment options, one can make use of either removable and/or fixed functional appliances. In the past, headgear has been used as a classic appliance for the correction of class II malocclusion. Other removable functional appliances (RFA) include Frankel, bionator and sander bite jumping appliances. Jasper jumper, Herbst appliance and mandibular protraction appliance (MPA) are the some of the fixed functional appliances (FFA) used. All these modalities are designed to modify the arches by re-orienting their position in both sagittal and vertical dimensions to bring about correction of main features of class II malocclusion.
AdvanSync2 (Ormco Co., Glendora, Calif) is a FFA being introduced recently as an advancement of Herbst appliance. It is a molar-to-molar appliance, connected by a telescopic rod, which allow for simultaneous treatment with braces. It is much smaller in size than the conventional Herbst appliance and reduces treatment duration up to six to nine months. It is much more acceptable by the patients as they complain less about sores and discomfort, and is esthetically pleasant since it's not visible in the mouth. Short arms of this appliance help to decrease irritation and discomfort of the patient, and helps to advance the mandible in a constant forward direction to encourage growth, and reduce malocclusion.
Twin block appliance (RFA) was introduced by William Clark in 1988. Many modifications for this appliance have been introduced lately. It has been named twin block for the characteristic of two unattached maxillary and mandibular plates with acrylic bite blocks, which makes 70o angle when come in contact with each other. This appliance is another treatment modality for cases with class II malocclusions, which can be carried out at an early age as well as the delayed treatment. However, delayed treatment was found to be much better for the patients in terms of less orthodontic visits.
AdvanSync2 appliance is a new treatment modality in orthodontics, and through thorough literature search, no study could be found in regard to this appliance in Pakistani population yet.Hence, the objective of this study was to compare dentoskeletal changes in skeletal class II malocclusion induced due to treatment with removable twin block appliance and fixed advanSync2 appliance in Pakistani population.
- Being tested
- Removable Twin Block, Fixed Functional , AdvanSync Appliance
- 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.
Removable Twin BlockDevice
Twin block appliance (RFA) was introduced by William Clark in 1988. Many modifications for this appliance have been introduced lately. It has been named twin block for the characteristic of two unattached maxillary and mandibular plates with acrylic bite blocks, which makes 70o angle when come in contact with each other. Delta clasps are added for better retention of the appliance. This appliance plays a vital role in the treatment of mandibular retrognathia
Fixed Functional , AdvanSync ApplianceDevice
AdvanSync2 (Ormco Co., Glendora, Calif) is a FFA being introduced recently as an advancement of Herbst appliance. It is a molar-to-molar appliance, connected by a telescopic rod, which allow for simultaneous treatment with braces. It is much smaller in size than the conventional Herbst appliance and reduces treatment duration up to six to nine months. It is much more acceptable by the patients as they complain less about sores and discomfort, and is esthetically pleasant since it's not visible in the mouth. Short arms of this appliance help to decrease irritation and discomfort of the patient, and helps to advance the mandible in a constant forward direction to encourage growth, and reduce malocclusion.
| Study group | Role | What they receive |
|---|---|---|
| Removable Twin Block appliance group | Patient to be treated with removable twin block appliance that are known Class II skeletal and dental subjects. Receives: Device: Removable Twin Block | |
| Fixed Functional Appliance AdvanSync group | Patients to be treated with fixed functional appliance, AdvanSync (Molar-to-Molar) Class II Corrector Receives: Device: Fixed Functional , AdvanSync Appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect of Class II malocclusion fixed functional bite corrector in comparison to class II removable bite corrector
efficacy of both the appliances is to be assessed
Measured: 9 to 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start12 Sep 2020
- Primary completion1 Oct 2021
- Study completion1 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Class II Division 1 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Fareena Ghaffar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Fareena Ghaffar, Armed Forces Institute of Dentistry, Pakistan
- Investigators
- Abdullah Jan, Postgraduate, Study director, Armed Forces institute of Dentistry (AFID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619446
- Sponsor's protocol ID
- AFIDPakistan
- Status last verified
- Jul 2022
- First submitted
- 9 Oct 2020
- Last updated
- 29 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dentoskeletal Changes of Twin Block Appliance and AdvanSync2 Appliance in Treatment of Skeletal Class II Malocclusion
- ClinicalTrials.gov ID
- NCT04619446
- Acronym / sponsor ID
- AFIDPakistan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dr. Fareena GhaffarUniversity, hospital or other
- Study start
- 12 Sep 2020 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Nov 2021 (actual)
- First posted
- 6 Nov 2020 (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.
To compare dentoskeletal changes in patients with skeletal class II malocclusion induced due to treatment with orthodontic appliances; removable twin block appliance and fixed AdvanSync2 appliance in two different age group patients.
Detailed description
41% of total orthodontic cases in Pakistani population are of class II malocclusion. Class II malocclusion is referred as maxillary protrusion, or mandibular retrusion, or combination of both, which can be corrected by treating the skeletal and dento-alveolar discrepancies. Out of many recommended treatment options, one can make use of either removable and/or fixed functional appliances. In the past, headgear has been used as a classic appliance for the correction of class II malocclusion. Other removable functional appliances (RFA) include Frankel, bionator and sander bite jumping appliances. Jasper jumper, Herbst appliance and mandibular protraction appliance (MPA) are the some of the fixed functional appliances (FFA) used. All these modalities are designed to modify the arches by re-orienting their position in both sagittal and vertical dimensions to bring about correction of main features of class II malocclusion.
AdvanSync2 (Ormco Co., Glendora, Calif) is a FFA being introduced recently as an advancement of Herbst appliance. It is a molar-to-molar appliance, connected by a telescopic rod, which allow for simultaneous treatment with braces. It is much smaller in size than the conventional Herbst appliance and reduces treatment duration up to six to nine months. It is much more acceptable by the patients as they complain less about sores and discomfort, and is esthetically pleasant since it's not visible in the mouth. Short arms of this appliance help to decrease irritation and discomfort of the patient, and helps to advance the mandible in a constant forward direction to encourage growth, and reduce malocclusion.
Twin block appliance (RFA) was introduced by William Clark in 1988. Many modifications for this appliance have been introduced lately. It has been named twin block for the characteristic of two unattached maxillary and mandibular plates with acrylic bite blocks, which makes 70o angle when come in contact with each other. This appliance is another treatment modality for cases with class II malocclusions, which can be carried out at an early age as well as the delayed treatment. However, delayed treatment was found to be much better for the patients in terms of less orthodontic visits.
AdvanSync2 appliance is a new treatment modality in orthodontics, and through thorough literature search, no study could be found in regard to this appliance in Pakistani population yet.Hence, the objective of this study was to compare dentoskeletal changes in skeletal class II malocclusion induced due to treatment with removable twin block appliance and fixed advanSync2 appliance in Pakistani population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Removable Twin Block appliance group | – | Device: Removable Twin BlockPatient to be treated with removable twin block appliance that are known Class II skeletal and dental subjects. |
| Fixed Functional Appliance AdvanSync group | – | Device: Fixed Functional , AdvanSync AppliancePatients to be treated with fixed functional appliance, AdvanSync (Molar-to-Molar) Class II Corrector |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- A.F.I.D, Rawalpindi. Thirty patients ( 15 between cervical vertebral maturation (CVM) stage of 2-3 to be treated with removable functional applianc and remaining 15 between CVM stage of 4-5 to be treated with fixed functional appliance) with skeletal class II malocclusion, presented at the department of Armed forces institute of dentistry (AFID).
Key inclusion criteria (6 listed)
- Class II div 1 malocclusion with mandible being placed backwards (SNB angle <78o)
- Convex facial profile
- ANB angle to be >4 degree
- overall good oral health
- no previous orthodontic treatment being done
Key exclusion criteria (3 listed)
- Subjects presenting with any developmental defects
- Asymmetrical facial profile
- Impacted / missing / supernumerary or transposed teeth
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 |
|---|---|---|
| Removable Twin BlockTwin block appliance (RFA) was introduced by William Clark in 1988. Many modifications for this appliance have been introduced lately. It has been named twin block for the characteristic of two unattached maxillary and mandibular plates with acrylic bite blocks, which makes 70o angle when come in contact with each other. Delta clasps are added for better retention of the appliance. This appliance plays a vital role in the treatment of mandibular retrognathia | Device | Removable Twin Block appliance group |
| Fixed Functional , AdvanSync ApplianceAdvanSync2 (Ormco Co., Glendora, Calif) is a FFA being introduced recently as an advancement of Herbst appliance. It is a molar-to-molar appliance, connected by a telescopic rod, which allow for simultaneous treatment with braces. It is much smaller in size than the conventional Herbst appliance and reduces treatment duration up to six to nine months. It is much more acceptable by the patients as they complain less about sores and discomfort, and is esthetically pleasant since it's not visible in the mouth. Short arms of this appliance help to decrease irritation and discomfort of the patient, and helps to advance the mandible in a constant forward direction to encourage growth, and reduce malocclusion. | Device | Fixed Functional Appliance AdvanSync group |
Primary outcome
effect of Class II malocclusion fixed functional bite corrector in comparison to class II removable bite corrector
Time frame: 9 to 10 months
efficacy of both the appliances is to be assessed
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 29 Jul 2022.
- Individual participant dataSharing planned: No
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EVALUATION OF TREATMENT CHANGES IN CLASS II DIVISION 1 MALOCCLUSION DURING EN MASSE RETRACTION OF UPPER ANTERIOR TEETH USING MINI IMPLANTS PLACED AT INFRAZYGOMATIC CREST AND INTERRADICULAR SITES A RANDOMIZED CLINICAL TRIAL.
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The Effectiveness of the Twin Block and Carriere Motion Appliances in Post-pubertal Patients and an Evaluation of the Impact of Class II Malocclusion and Its Correction on Oral Health-related Quality of Life
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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.
Abdullah Jan, Postgraduate study director
Armed Forces institute of Dentistry (AFID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Class II Division 1 Malocclusion and Mandibular Retrognathism, run by Dr. Fareena Ghaffar at 1 site in Pakistan.
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 6 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 29 Jul 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 Pakistan. 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?
effect of Class II malocclusion fixed functional bite corrector in comparison to class II removable bite corrector (time frame: 9 to 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2022; AzTrials last refreshed its copy on 6 Nov 2026.