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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Cairo University
- Enrollment
- 30
- Primary Endpoint
- Root proximity
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
during the insertion procedure the principle investigator and the co supervisor couldn't be blinded, as the two insertion techniques are completely different.
Eligibility Criteria
- Ages
- 14 Years to 45 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Three dimensional printed digital guide
one mini-screw will be inserted in the buccal interradicular space between upper second premolar and first molar using Three dimensional printed digital guide, which is a device deisgned and printed through CAD/CAM technology, it's a printed plate fit on the teeth and buccal mucosa with a channel for mini- screw insertion, mini-screw will be inserted through the plate's channel
Intervention: Three dimensional printed digital guide (Device)
Conventional free hand insertion
one mini-screw will be inserted in the buccal interradicular space between upper second premolar and first molar using conventional free hand insertion of mini-screw, which is a technique using the guiding anatomy for mini-screw insertion using the driver and the operator's skill.
Outcomes
Primary Outcomes
Root proximity
Time Frame: immediately after mini-screw insertion (T0)
Distance between inserted mini screw and the adjacent roots in microns
Secondary Outcomes
- Patient discomfort:(immediately after mini-screw insertion (T0))
Investigators
Hadir Aboshady
Principle investigator
Cairo University
