3D Printed Reverse Twin Block for Class III Malocclusion
ConditionClass III Malocclusion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-13
SponsorUniversity of Baghdad
About this trial
This RCT aims to evaluate the effectiveness of a novel 3D printed reverse twin block appliance in the management of maxillary deficiency in growing patients having class III malocclusion. The clinical outcomes of this appliance will be compared with the conventional reverse twin block appliance over 6 months treatment period.
primary objective is evaluating of the effectiveness of 3DRTB in correcting sagittal discrepancies due to maxillary deficiency in class III malocclusion compared to conventional one while secondary objectives are assessment of transverse and vertical jaw relationship produced by 3DRTB compared to CRTB and to evaluate the soft tissue profile of class III patients and to evaluate the maxillary and mandibular incisor inclination, also assessment of patient perception with both appliances by using questionnaire and finally to assess the impact of 3DRTB on oral health compared to CRTB by using oral hygiene index.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The age group selected is mixed dentition group 8-13 years with residual potential maxillary growth. Patient maturity will be assessed using the Cervical Vertebral Maturation (CVM) method on lateral cephalogram, patients in CS1-CS3 stages will be included to ensure remaining maxillary growth.
Presence of permanent first molar with lower anterior teeth to retain the appliance.
Skeletal/dental class III tendency with anterior cross bite or reverse overjet: a. Clinically the overjet is equal or less than zero up to -3 mm.
Prescence of unilateral or bilateral posterior crossbite.
Disqualifiers
Patients with cleft lip and palate and/or craniofacial anomalies.
History of previous orthopedic and/or orthodontic treatment.
Presence of uncontrolled systemic disease or medically compromised status.
Uncooperative patient/parents.
Trial design
Design model
Parallel
Treatments tested in this trial
3D printed Reverse Twin Block appliance
Devicea CAD-CAM novel reverse twin block appliance will be used for orthopedic management of maxillary deficiency in growing patients with class III malocclusion.
Conventional Reverse Twin Block appliance
Devicea conventionally fabricated Reverse Twin Block appliance will be used for correction of maxillary deficiency in growing patients with class III malocclusion
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: 3D printed Reverse Twin Block applianceExperimental treatment 1 intervention
Group B: Conventional Reverse Twin Block applianceActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in sagittal relation using lateral cephalometric radiograph.
By using cephalometric radiograph skeletal changes in sagittal plane will be measured like: 1. SNA angle in degrees. 2. SNB angle in degrees. 3. ANB angle in degrees. 4. Wits appraisal in degrees. 5. SN-Pog angle
Time frame
T0 baseline records T1 3 months after initiation of treatment T2 6 months after initiation of treatmentSecondary outcomes
1
Transverse relationship by Study model
This will measure by scanned digital study model to calculate the amount of expansion at T0, T1, T2. 1. Intermolar width: which is the distance between the mesiobuccal cusp tips of the right and left maxillary first molars. 2. Arch length: Arch length will be achieved by measuring the summation of right and left lines that passing through the midpoint between the distal surfaces of the deciduous second molar or the first permanent molar to the midpoint between the central incisors.
Time frame
T0 baseline records T1 after 3 months T2 after 6 monthsOther outcomes
1
Oral hygiene index-children (OHI-C) will be measured
The six index teeth that will be included: 1. 16/55: Maxillary right permanent first molar or maxillary right primary second molar. 2. 11/51: Maxillary right permanent central incisor or maxillary right primary central incisor. 3. 26/65: Maxillary left permanent first molar or maxillary left primary second molar. 4. 36/75: Mandibular left permanent first molar or mandibular left primary second molar. 5. 31/71: Mandibular left permanent central incisor or mandibular left primary central incisor. 6. 46/85: Mandibular right permanent first molar or mandibular right primary second molar.
Time frame
T0 baseline record T1 after 3 months T2 after 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov