3D Printed Reverse Twin Block for Class III Malocclusion (3DRTB)
Effectiveness of a Novel 3D Printed Reverse Twin Block in The Management of Maxillary Deficiency of Class III Malocclusion: A Randomized Clinical 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Linda Basim, PhD
- Telefonnummer: +9647812867005
- E-post: landa.hadi2403@codental.uobaghdad.edu.iq
Studieorter
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Baghdad, Irak
- Rekrytering
- Collage of Dentistry, University of Baghdad
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- 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.
b. Cephalometric ANB angle equal or less than zero up to -3 degrees and Wits appraisal ≤ -2.
- Prescence of unilateral or bilateral posterior crossbite.
- Mild to moderate anterior crowding.
- Acceptable oral hygiene baseline defined by oral hygiene index (OHI). -
Exclusion Criteria:
- 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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 3D printed Reverse Twin Block appliance
patients with class III malocclusion will receive a novel 3D printed reverse twin block with expansion screw for expansion and protraction of maxilla and will be digitally designed using CAD software and fabricated using photopolymer resin.
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a CAD-CAM novel reverse twin block appliance will be used for orthopedic management of maxillary deficiency in growing patients with class III malocclusion.
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Aktiv komparator: Conventional Reverse Twin Block appliance
patients with class III malocclusion will receive a conventional reverse twin block with expansion screw for expansion and protraction of maxilla and will be fabricated from acrylic resin.
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a conventionally fabricated Reverse Twin Block appliance will be used for correction of maxillary deficiency in growing patients with class III malocclusion
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Changes in sagittal relation using lateral cephalometric radiograph.
Tidsram: T0 baseline records T1 3 months after initiation of treatment T2 6 months after initiation of treatment
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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
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T0 baseline records T1 3 months after initiation of treatment T2 6 months after initiation of treatment
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Transverse relationship by Study model
Tidsram: T0 baseline records T1 after 3 months T2 after 6 months
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This will measure by scanned digital study model to calculate the amount of expansion at T0, T1, T2.
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T0 baseline records T1 after 3 months T2 after 6 months
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Oral hygiene index-children (OHI-C) will be measured
Tidsram: T0 baseline record T1 after 3 months T2 after 6 months
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The six index teeth that will be included:
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T0 baseline record T1 after 3 months T2 after 6 months
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1213426
Plan för individuella deltagardata (IPD)
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