Faculty of Dentistry, Alexandria University
Alexandria, Egypt
NCT Number: NCT06991699
The objective of this study is to assess the effectiveness of a Polyether ether ketone (PEEK) stent for management of gummy smile.
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Notify Me20 year and older
All sexes
Interventional
Not applicable
Alexandria, Egypt
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A CBCT will be performed to assess the anatomy of the subnasal area and plan the position, size, shape and thickness of the PEEK Stent. These data will be transferred to a 3D planning software to generate a digital model. Eventually, the PEEK stents will be milled in a milling machine and sterilized in ethylene oxide before the surgery. Local anesthesia will be administered into the vestibular mucosa along the extension of the anterior maxilla. VISTA technique begins with a vestibular access incision in the midline frenum and 2 bilateral incisions at premolar area. A periosteal elevator will be introduced through the incision and inserted between the bone and periosteum to elevate the tissue, creating a subperiosteal tunnel, extending distally based on the dynamic of the smile. The PEEK stent will be in one piece. They will be placed onto the bone and stabilized with 2 bone graft screw for each side. The midline incision and the lateral incisions will be sutured primarily.
Time frame: up to 9 months
Distance from gingival margin to lower border of upper lip vermilion border will be measured
Time frame: up to 9 months
evaluated using a 10-point visual analogue scale (VAS; 0 = not satisfied, 10 = highly satisfied)
Time frame: up to 9 months
taher helmy ismail metwaly
Other
A Novel Digitally Driven Approach for Gummy Smile Solution Using Milled Sub-nasal Stent: A Clinical Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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