Class II Division 1 MalocclusionNCT03467555
Evaluation of Distal Movement of Maxillary Dentition With Zygomatic Miniplates Using Cone Beam Computed Tomography
A study testing Class II correction using miniplates in zygomatic region in people with Class II Division 1 Malocclusion, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
The main objective of this study is to quantify the distal movement of maxillary central incisors and molars achieved with miniplate anchorage. Read more about this study
- Who is it for?
- Ages 17 to 35 years
- Conditions the study is for
- Class II Division 1 Malocclusion
- What is being tested?
- Class II correction using miniplates in zygomatic region
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2016to Dec 2019
- 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 17 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Non growing patients
- Bilateral Class II molar relationship, defined by at least end-to-end molar relationship.
- No or minor crowding in the mandible.
- Treatment completion without any permanent teeth extracted (excluding third molars).
- Both 1st and 2nd maxillary molars present on the side with a Class II relationship.
- Horizontal to average growth pattern.
Who cannot join
- Subjects with a history of fixed orthodontic treatment.
- Crossbite
- Vertical growth pattern
- Any systemic disease affecting bone and general growth
- Poor oral hygiene
- Cleft patients
- Patients who fail to follow up or undergo complete treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Distal Movement of Maxillary Dentition With Zygomatic Miniplates: a Clinical Study Using Cone Beam Computed Tomography
The main objective of this study is to quantify the distal movement of maxillary central incisors and molars achieved with miniplate anchorage.
Read the detailed description
Premolar extraction treatment with multibracketed system and reinforced anchorage has been a common modality for correcting maxillary incisor crowding or Class II malocclusion in nongrowing patients. Treatment of Class II malocclusion without extraction frequently requires distalization of maxillary molars into Class I relation by means of extraoral or intraoral forces. Previously, it had been difficult to move maxillary molars distally after full eruption of maxillary 2nd molars. Extraoral headgear traction restricting the forward growth of maxilla and /or distalizing the maxillary dentition has been the most commonly used and oldest method to correct a Class II buccal segment molar relationship.This distalizes not only 1st molar but also maxillary 1st and 2nd premolars via transeptal fibers. Headgear is seldom an option in adults due to aesthetics and compliance concerns. The disadvantages of extraoral appliances have motivated many investigators to develop the mechanics of intraoral molar distalization.
Various intraoral non compliance appliances like nickel-titanium spring , magnets , distal jet , pendulum appliances have been used to distalize maxillary molars. However, in these appliances, anchorage loss characterized by protrusion of maxillary incisors and an increase in overjet is seen. Also considerable amount of relapse occurred when the distalized molars were used as anchorage for the retraction of anteriors and premolar teeth.
Absolute skeletal anchorage available 24 hours a day is an alternative method for molar distalization. It provides stationary anchorage for various tooth movements without the need for active patient compliance and with no undesirable side effects. Miniscrews, which are generally placed between the roots, limit the amount of distalization possible as they come in contact with surrounding roots during tooth movement. Also, proximity of miniscrews to the roots may lead to failure of screw anchorage .These disadvantages can be overcome by the use of miniplates which are fixed at a distance from the root apices, and therefore do not interfere in tooth movement.
Until now, there have been only a few clinical studies on group distalization of posterior teeth. Thus, little information is available regarding the type of tooth movement that occurs and the limitations of distal movement. An attempt was also not made to study the root resorption and the amount of distal movement or tipping of maxillary 2nd molars since lateral cephalometric radiographs do not provide a clear view of this region.
To the best of our knowledge, no previous study has been conducted on Cone Beam Computed Tomography to evaluate the amount of distal movement of entire maxillary dentition using miniplates placed in zygomatic region and assess the root resorption in all the roots of maxillary molars. The purpose of this study is to evaluate distal movement of maxillary dentition using Cone Beam Computed Tomography to overcome the shortcomings of the previous studies.
MATERIALS AND METHOD Ours is a prospective clinical study to evaluate the distal movement of maxillary dentition achieved in three dimensions with miniplates placed in zygomatic region for the purpose of anchorage. The present study will be conducted in the Department of Orthodontics and Dentofacial Orthopaedics, in conjunction with Department of Oral and Maxillofacial Surgery, P.G.I.D.S., Pt. B.D.Sharma University of Health Sciences, Rohtak. The study will be carried out after the institutional approval obtained from the ethical committee.
SOURCE OF DATA The sample size consists of 20 subjects selected from the patients attending the regular Out Patient Department at the Department of Orthodontics and Dentofacial Orthopaedics for orthodontic treatment.
TARGET SAMPLE SIZE A sample size of 17 for the present study was calculated at 90% power.To compensate for 10% dropouts the final sample size was calculated to be 20.
INTERVENTION AND DESIGN OF STUDY The main intervention in this clinical trial is surgical placement of zygomatic miniplates after initial leveling and alignment of maxillary dental arch. After selection of subjects (patients meeting selection criteria), treatment with 0.022" MBT preadjusted edgewise appliance was started. Maxillary arch will be stabilized with the help of 0.019" × 0.025" stainless steel wire. Pre-treatment diagnostic records and Cone Beam Computed Tomography will be taken before placing miniplates . Maxillary 3rd molars will be extracted, if present . L shaped 2mm titanium miniplates (OrthoMax,Vadodara , India) will be surgically placed under local anaesthesia in aseptic conditions at zygomatic region bilaterally. Hooks will be soldered on archwire used for stabilizing dentition. Ni-Ti closed coil spring/Elastomeric chain will be used to apply a force on both sides (calibrated using Dontrix Gauge ) from miniplates to soldered hooks. Patient will be recalled at 4 weeks interval. Records including Cone Beam Computed Tomography will be taken on achievement of Class I molar relation bilaterally. Lateral cephalograms and CBCT will be taken 2 years post retention.
DATA COLLECTION AND CONE BEAM COMPUTED TOMOGRAPHY ANALYSIS The investigator will record the patients' name, address, contact number and other relevant case history records will be taken. Cephalometric radiographs and Cone Beam Computed Tomography and will be recorded before placement of zygomatic miniplates, on achievement of Class I molar relation bilaterally and 2 years post retention for assessment of distalization. These records will be analyzed. The relevant values will be entered in a predesigned format. Soft tissue profile changes between pretreatment and post treatment will be assessed on lateral cephalogram and the raters- orthodontist, laypersons,patients,parents and general dentists will assess changes in facial appearance on a visual analog scale with profile photographs. Patient perception will be assessed using questionnaire rating by patient regarding various parameters at 1 week, 2 weeks, 1 month and 6 months after the placement of miniplate in zygomatic region. Changes in the upper-airway size will be measured by using lateral cephalometric radiographs taken before and after distalization.
INFORMED CONSENT OF THE PATIENT A valid, informed written consent of the patient or parent/ guardian will be obtained from the patient before registering the patient in this clinical study . Patient will be informed about all the theoretical risks and benefits of the intervention under test .Risks and hazards of radiation during CBCT will also be explained to the patient. The patient will be given 72 hours to discuss the study with his/her family and take the decision regarding participation in the study
- Conditions
- Class II Division 1 Malocclusion
- Being tested
- Class II correction using miniplates in zygomatic region
- 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.
Class II correction using miniplates in zygomatic regionDevice
| Study group | Role | What they receive |
|---|---|---|
| distalization group | Experimental | Class II correction using zygomatic miniplates Receives: Device: Class II correction using miniplates in zygomatic region |
What is being measured
The primary outcome is the main question the study is designed to answer.
distal movement of maxillary molars and central incisors measured in mm at crown and root levels
distal movement of maxillary molars and central incisors before and after intervention measured in mm at crown and root levels on Cone Beam Computed Tomography
Measured: 24 months
root resorption of maxillary teeth
root resorption of maxillary incisors, canines, premolars and molars evaluated by measuring the root lengths along the long axis of the roots from cemento- enamel junction to the root tips in mm on Cone Beam Computed Tomography before and after intervention
Measured: 24 months
patient experiences with zygomatic miniplates
questionaires given to patients for evaluating patient attitude and pain perception (using Visual Analog Scale) at different time intervals.
Measured: 20 months
soft tissue profile changes
soft tissue profile changes after intervention evaluated on lateral cephalogram and the raters- orthodontist, laypersons,patients,parents and general dentists will assess changes in facial appearance on a visual analog scale with profile photographs
Measured: 30 months
Secondary outcomes (4)
mandibular plane angle
changes in mandibular plane angle after intervention
Measured: 24 months
the movement of maxillary central incisors and molars in vertical plane
the movement of maxillary central incisors and molars in vertical plane assessed by measuring the perpendicular distance between the incisal edge/ mesio-buccal cusp to the palatal plane on Cone Beam Computed Tomography
Measured: 24 months
transverse changes
intercanine and intermolar width will be assessed on CBCT before and after distalization
Measured: 24 months
Airway changes
changes in the upper-airway size will be measured by using lateral cephalometric radiographs before and after distalization
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study startDec 2016
- Primary completionOct 2019
- Study completionDec 2019
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.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sonal Chowdhary, Principal investigator, Post Graduate Institute of Dental Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467555
- Sponsor's protocol ID
- sonal tulika
- Status last verified
- Jun 2020
- First submitted
- 3 Mar 2018
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Distal Movement of Maxillary Dentition With Zygomatic Miniplates: a Clinical Study Using Cone Beam Computed Tomography
- ClinicalTrials.gov ID
- NCT03467555
- Acronym / sponsor ID
- sonal tulika
- Conditions
- Class II Division 1 Malocclusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 16 Mar 2018 (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.
The main objective of this study is to quantify the distal movement of maxillary central incisors and molars achieved with miniplate anchorage.
Detailed description
Premolar extraction treatment with multibracketed system and reinforced anchorage has been a common modality for correcting maxillary incisor crowding or Class II malocclusion in nongrowing patients. Treatment of Class II malocclusion without extraction frequently requires distalization of maxillary molars into Class I relation by means of extraoral or intraoral forces. Previously, it had been difficult to move maxillary molars distally after full eruption of maxillary 2nd molars. Extraoral headgear traction restricting the forward growth of maxilla and /or distalizing the maxillary dentition has been the most commonly used and oldest method to correct a Class II buccal segment molar relationship.This distalizes not only 1st molar but also maxillary 1st and 2nd premolars via transeptal fibers. Headgear is seldom an option in adults due to aesthetics and compliance concerns. The disadvantages of extraoral appliances have motivated many investigators to develop the mechanics of intraoral molar distalization.
Various intraoral non compliance appliances like nickel-titanium spring , magnets , distal jet , pendulum appliances have been used to distalize maxillary molars. However, in these appliances, anchorage loss characterized by protrusion of maxillary incisors and an increase in overjet is seen. Also considerable amount of relapse occurred when the distalized molars were used as anchorage for the retraction of anteriors and premolar teeth.
Absolute skeletal anchorage available 24 hours a day is an alternative method for molar distalization. It provides stationary anchorage for various tooth movements without the need for active patient compliance and with no undesirable side effects. Miniscrews, which are generally placed between the roots, limit the amount of distalization possible as they come in contact with surrounding roots during tooth movement. Also, proximity of miniscrews to the roots may lead to failure of screw anchorage .These disadvantages can be overcome by the use of miniplates which are fixed at a distance from the root apices, and therefore do not interfere in tooth movement.
Until now, there have been only a few clinical studies on group distalization of posterior teeth. Thus, little information is available regarding the type of tooth movement that occurs and the limitations of distal movement. An attempt was also not made to study the root resorption and the amount of distal movement or tipping of maxillary 2nd molars since lateral cephalometric radiographs do not provide a clear view of this region.
To the best of our knowledge, no previous study has been conducted on Cone Beam Computed Tomography to evaluate the amount of distal movement of entire maxillary dentition using miniplates placed in zygomatic region and assess the root resorption in all the roots of maxillary molars. The purpose of this study is to evaluate distal movement of maxillary dentition using Cone Beam Computed Tomography to overcome the shortcomings of the previous studies.
MATERIALS AND METHOD Ours is a prospective clinical study to evaluate the distal movement of maxillary dentition achieved in three dimensions with miniplates placed in zygomatic region for the purpose of anchorage. The present study will be conducted in the Department of Orthodontics and Dentofacial Orthopaedics, in conjunction with Department of Oral and Maxillofacial Surgery, P.G.I.D.S., Pt. B.D.Sharma University of Health Sciences, Rohtak. The study will be carried out after the institutional approval obtained from the ethical committee.
SOURCE OF DATA The sample size consists of 20 subjects selected from the patients attending the regular Out Patient Department at the Department of Orthodontics and Dentofacial Orthopaedics for orthodontic treatment.
TARGET SAMPLE SIZE A sample size of 17 for the present study was calculated at 90% power.To compensate for 10% dropouts the final sample size was calculated to be 20.
INTERVENTION AND DESIGN OF STUDY The main intervention in this clinical trial is surgical placement of zygomatic miniplates after initial leveling and alignment of maxillary dental arch. After selection of subjects (patients meeting selection criteria), treatment with 0.022" MBT preadjusted edgewise appliance was started. Maxillary arch will be stabilized with the help of 0.019" × 0.025" stainless steel wire. Pre-treatment diagnostic records and Cone Beam Computed Tomography will be taken before placing miniplates . Maxillary 3rd molars will be extracted, if present . L shaped 2mm titanium miniplates (OrthoMax,Vadodara , India) will be surgically placed under local anaesthesia in aseptic conditions at zygomatic region bilaterally. Hooks will be soldered on archwire used for stabilizing dentition. Ni-Ti closed coil spring/Elastomeric chain will be used to apply a force on both sides (calibrated using Dontrix Gauge ) from miniplates to soldered hooks. Patient will be recalled at 4 weeks interval. Records including Cone Beam Computed Tomography will be taken on achievement of Class I molar relation bilaterally. Lateral cephalograms and CBCT will be taken 2 years post retention.
DATA COLLECTION AND CONE BEAM COMPUTED TOMOGRAPHY ANALYSIS The investigator will record the patients' name, address, contact number and other relevant case history records will be taken. Cephalometric radiographs and Cone Beam Computed Tomography and will be recorded before placement of zygomatic miniplates, on achievement of Class I molar relation bilaterally and 2 years post retention for assessment of distalization. These records will be analyzed. The relevant values will be entered in a predesigned format. Soft tissue profile changes between pretreatment and post treatment will be assessed on lateral cephalogram and the raters- orthodontist, laypersons,patients,parents and general dentists will assess changes in facial appearance on a visual analog scale with profile photographs. Patient perception will be assessed using questionnaire rating by patient regarding various parameters at 1 week, 2 weeks, 1 month and 6 months after the placement of miniplate in zygomatic region. Changes in the upper-airway size will be measured by using lateral cephalometric radiographs taken before and after distalization.
INFORMED CONSENT OF THE PATIENT A valid, informed written consent of the patient or parent/ guardian will be obtained from the patient before registering the patient in this clinical study . Patient will be informed about all the theoretical risks and benefits of the intervention under test .Risks and hazards of radiation during CBCT will also be explained to the patient. The patient will be given 72 hours to discuss the study with his/her family and take the decision regarding participation in the study
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| distalization group | Experimental | Device: Class II correction using miniplates in zygomatic regionClass II correction using zygomatic miniplates |
Who may qualify
- Ages
- 17 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Non growing patients
- Bilateral Class II molar relationship, defined by at least end-to-end molar relationship.
- No or minor crowding in the mandible.
- Treatment completion without any permanent teeth extracted (excluding third molars).
- Both 1st and 2nd maxillary molars present on the side with a Class II relationship.
Key exclusion criteria (7 listed)
- Subjects with a history of fixed orthodontic treatment.
- Crossbite
- Vertical growth pattern
- Any systemic disease affecting bone and general growth
- Poor oral hygiene
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Class II correction using miniplates in zygomatic region | Device | distalization group |
Primary outcome
distal movement of maxillary molars and central incisors measured in mm at crown and root levels
Time frame: 24 months
distal movement of maxillary molars and central incisors before and after intervention measured in mm at crown and root levels on Cone Beam Computed Tomography
root resorption of maxillary teeth
Time frame: 24 months
root resorption of maxillary incisors, canines, premolars and molars evaluated by measuring the root lengths along the long axis of the roots from cemento- enamel junction to the root tips in mm on Cone Beam Computed Tomography before and after intervention
patient experiences with zygomatic miniplates
Time frame: 20 months
questionaires given to patients for evaluating patient attitude and pain perception (using Visual Analog Scale) at different time intervals.
soft tissue profile changes
Time frame: 30 months
soft tissue profile changes after intervention evaluated on lateral cephalogram and the raters- orthodontist, laypersons,patients,parents and general dentists will assess changes in facial appearance on a visual analog scale with profile photographs
4 secondary outcomes
mandibular plane angle
Time frame: 24 months
the movement of maxillary central incisors and molars in vertical plane
Time frame: 24 months
transverse changes
Time frame: 24 months
Airway changes
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Individual participant dataSharing planned: Yes
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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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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.
Sonal Chowdhary principal investigator
Post Graduate Institute of Dental Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Class II correction using miniplates in zygomatic region in people with Class II Division 1 Malocclusion, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
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 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2020. 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 India. 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?
distal movement of maxillary molars and central incisors measured in mm at crown and root levels (time frame: 24 months). The study lists 4 primary outcomes in all. 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 9 Jun 2020.