Clinical trial NCT03653078: Root Proximity During Mini-Screw Insertion Using a Digital Three-Dimensional Printed Guide
Official title: Evaluation of Root Proximity During Mini-Screw Insertion Using a Digital Three-Dimensional Printed Guide Versus Conventional Free Hand Placement Technique in Adult Orthodontic Patients A Split Mouth Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orthodontic Appliance Complication
Keywords: Surgical guide
Surgical stent
orthodontic mini screw
temporary anchorage device
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: adult orthodontic participants
Primary purpose: TREATMENT

Brief summary: Although mini screw insertion is considered as a simple and non-invasive technique, it's a critical procedure which requires precision and accuracy. The placement of mini-screw poses a challenge to the orthodontist, particularly if the space available for mini-screws is limited.4 The proximity to the vital structures surrounding the proposed mini-screw position necessitates the precise knowledge of the anatomy of the insertion area.5 The incidence of mini-screw to tooth contact in the placement of inter-radicular region was 27%.6 Although failure of mini screw is considered a multi-factorial concern, many studies reported the proximity of a mini-screw to tooth structures is a major risk factor for failure, especially in the inter-radicular inserted mini-screws. guided insertion was believed to give more favorable results. Above all, the recent technology of the scanning and three-dimensional printing could pave the way to construct a simple accurate guide. Additionally all previous studies assessed the insertion accuracy using CBCT post-operatively, that can't be applied on human subjects for ethical reasons. Thus a non-invasive method for assessment of mini-screw insertion should be implemented.

Detailed description: PICOs P: Adult orthodontic patients need mini screws in maxillary arch bilaterally for anchorage I: Three dimensional printed digital guide for mini screw insertion C: Conventional free hand insertion technique

- O: Primary outcome: Root proximity

Secondary outcomes:

* Patient discomfort during insertion 17
* Insertion accuracy
* Angular deviation
* Linear deviation
* Failure 18 S: Split Mouth Randomized clinical Trial

Eligibility criteria: Inclusion Criteria:

* Orthodontic patients with Angle's Class I bimaxillary protrusion • Patients having average mandibular plane angle

Exclusion Criteria:

* Mixed dentition patients

  * Smoker patients
  * Patients with Increased lower facial height
  * Patients with missing posterior teeth
  * Bleeding disorders or anticoagulant therapy
  * Patients with cleft lip \& palate
  * Patients with facial asymmetry
  * Patients with transverse maxillary deficiency

Primary outcomes:
measure: Root proximity
timeFrame: immediately after mini-screw insertion (T0)
Secondary outcomes:
measure: Patient discomfort:
timeFrame: immediately after mini-screw insertion (T0)
Other outcomes:
Locations:
Study officials:
References:
citation: Bae MJ, Kim JY, Park JT, Cha JY, Kim HJ, Yu HS, Hwang CJ. Accuracy of miniscrew surgical guides assessed from cone-beam computed tomography and digital models. Am J Orthod Dentofacial Orthop. 2013 Jun;143(6):893-901. doi: 10.1016/j.ajodo.2013.02.018.
citation: Suzuki EY, Suzuki B. Accuracy of miniscrew implant placement with a 3-dimensional surgical guide. J Oral Maxillofac Surg. 2008 Jun;66(6):1245-52. doi: 10.1016/j.joms.2007.08.047.