NCT06017791

Management of Excess Gingival Display Using Tunnel Technique With 3D Designed PEEK Shell: A Case Series

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The aim of the current study is to evaluate the use of a PEEK shell placed in the anterior maxilla placed by tunnel technique in decreasing the gingival display

Detailed description

While lip repositioning has been established as a treatment modality to address excess gum display (EGD) , an often overlooked contributing factor is the lack of lip support. This is often caused by the architecture of the maxilla at the subnasal area. Maxillary overgrowth may give rise to a subnasal skeletal depression producing decreased lip support and marked upper lip retraction during a smile. Restricting muscle pull by lip repositioning surgery as a treatment option limits muscle movement, however it does not address lip support. In 2018 an alternative intervention was later proposed in a case report study . The technique involves raising a full thickness flap and applying PMMA (polymethyl methacrylate) cement to fill the subnasal depression and limit the upper lip movement. Since its introduction, a limited number of studies have attempted to investigate the technique, however there are not enough studies to support the outcome or the stability of the technique. The aim of the current study is to evaluate the use of a tunnel technique with a 3D printed PEEK (Polyetherether ketone) shell to fill the skeletal subnasal depression

Conditions

• Excessive Gingival Display

Interventions

Type	Name	Description
OTHER	tunnel technique with a 3D printed PEEK shell to fill the skeletal subnasal depression	The area will be anesthetized using infiltration technique with 1.5ml of anesthetic solution containing Articaine Hydrochloride 68 mg/1.7 ml with Adrenaline 0.017 mg/1.7 ml Two bilateral full thickness vertical incisions will be created using a #15 blade. One on each side of the frenum A subperiosteal tunnel connecting the two vertical incisions will be created using a periosteal elevator/tunneling knife until the complete communication between the two ends is established The custom made PEEK framework will be inserted from the incision on one side and eased through until it sits in the subnasal concavity. Once fitted in place the shell will be fixed in place using two mini screws bilaterally, one on each side. The two vertical incisions will be closed by interrupted sutures 6-0 Polyglycolic acid suture material

Timeline

• Start date: 2023-11-08
• Primary completion: 2026-01-07
• Completion: 2026-01-07
• First posted: 2023-08-30
• Last updated: 2026-03-23

Locations

1 site across 1 country: Egypt