Management of Excess Gingival Display Using Tunnel Technique With 3D Printed PEEK (Polyetheretherketone) Shell: A Case Series

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Excessive Gingival Display

Intervention / Treatment
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* Other: tunnel technique with a 3D printed PEEK shell to fill the skeletal subnasal depression


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with excess gingival display 2.5mm or more Patients with an exaggerated subnasal concavity Decreased value of SNA ( angle between sella, nation, A point) in cephalometric measurement Decreased cephalometric measurement of A to N-perpendicular (perpendicular from N on FHP) Decreased value in cephalometric measurement of the convexity at point A (linear measurement from point A to facial plane) Decreased value of Ricketts Esthetic plane in cephalometric measurement Decreased value of Holdaway H-angle in cephalometric measurement Nasolabial angle 100° ± 20 Patients 20-60 years old Medically free Compliant patient that agrees to the follow up period Exclusion Criteria: Pregnant and lactating females Smokers Diabetics Patients with parafunctional habits that may affect the outcome of the procedure Medically compromised patients

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEEK shell in the anterior maxilla inserted by tunnel technique<br>use of a minimally invasive tunnel technique to fill the skeletal subnasal depression with a PEEK shell in patients with an exaggerated subnasal depression associated with lack of lip support and excessive lip translation | Other: tunnel technique with a 3D printed PEEK shell to fill the skeletal subnasal depression<br>* 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 above the maxillary canines in the alveolar mucosa 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingival display | measured using a periodontal probe in millimeters | Day 0 - Month 3 - Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lip translation | measured using a periodontal probe in millimeters | Day 0 - Month 3 - Month 6 | 
| profile angle | lateral cephalometric xray | Day 0 - Month 6 | 
| lip length | measured using a periodontal probe in millimeters | Day 0 - Month 3 - Month 6 | 
| patient satisfaction | measured by a binary Questionnaire ( yes or no) | Day 7 | 
| Post operative pain | Measured by the visual analogue scale ( 0 no pain, 10 worst pain) | Day 7 | 
| blinded esthetic assessment | measured by a binary scale (yes or no) | Month 3- Month 6 |