Comparative Evaluation of Milled Polyether Ether Ketone (PEEK) Stent Placement and Lip Repositioning Surgery on the Treatment of Gummy Smile
NCT ID: NCT06983262
Last Updated: 2025-07-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
16 participants
INTERVENTIONAL
2024-02-14
2025-04-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Novel Digitally Driven Approach for Gummy Smile Solution Using Milled Sub-nasal Stent
NCT06991699
3D Printed Implant for Management of Gummy Smile Through VISTA Technique
NCT06473805
Comparison Between Lip Repositioning and Muscle Traction Technique in Treatment of Gummy Smile
NCT07285343
The Effect of Using Two Different Suturing Techniques on Free Gingival Marginal Stability
NCT04219436
Effect of Cross-linked Hyaluronic Acid Filler Versus Botulinum Toxin Type A (Botox) in Management of Gummy Smile
NCT06952218
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
VISTA and Milled PEEK stent
Milled PEEK Stent
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.
Lip repositioning surgery
Lip repositioning surgery
Profound anaesthesia will be achieved. A marking pencil§ will be used to outline the apical, coronal, and lateral boundaries of the elliptical incision. The coronal boundary will be at the mucogingival junction and will be used as a reference point to mark the apical boundary at two times the amount of gingival display. The coronal and apical incisions will be parallel to each other, and the apical incision gradually angled downward to meet the coronal incision. A partial thickness dissection will be made. The epithelium will be excised, exposing the underlying connective tissue. The mucosal flap will be advanced and sutured at the mucogingival junction.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Milled PEEK Stent
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.
Lip repositioning surgery
Profound anaesthesia will be achieved. A marking pencil§ will be used to outline the apical, coronal, and lateral boundaries of the elliptical incision. The coronal boundary will be at the mucogingival junction and will be used as a reference point to mark the apical boundary at two times the amount of gingival display. The coronal and apical incisions will be parallel to each other, and the apical incision gradually angled downward to meet the coronal incision. A partial thickness dissection will be made. The epithelium will be excised, exposing the underlying connective tissue. The mucosal flap will be advanced and sutured at the mucogingival junction.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Chiefs complain gummy smile
* Gummy smile due to short hypermobile upper lip
* Gingival Display not more than 5 mm
Exclusion Criteria
* Lactation
* History of smoking more than 10 cigarettes per day
* Systemic conditions or intake of medications that could affect soft and hard tissue healing
* Use of orthodontic appliances
* Gingival display above 5mm
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
taher helmy ismail metwaly
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
taher helmy ismail metwaly
MSc. Candidate in Periodontology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculty of Dentistry, Alexandria University
Alexandria, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1/3-2024
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.