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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06017791
Enrollment
10
Registered
2023-08-30
Start date
2023-11-08
Completion date
2026-01-07
Last updated
2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Excessive Gingival Display

Brief 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

Interventions

OTHERtunnel 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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

Inclusion criteria

* Patients with excess gingival display 2.5mm or more * Patients with an exaggerated subnasal concavity * Decreased/normal value of SNA ( angle between sella, nation, A point) in cephalometric measurement * Decreased/normal cephalometric measurement of A to N-perpendicular (perpendicular from N on FHP) * Decreased/normal value in cephalometric measurement of the convexity at point A (linear measurement from point A to facial plane) * Decreased/normal value of Ricketts Esthetic plane in cephalometric measurement * Decreased/normal value of Holdaway H-angle in cephalometric measurement * Nasolabial angle range from 100° to 120° * 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

Design outcomes

Primary

MeasureTime frameDescription
Gingival displayDay 0 - Month 3 - Month 6measured using a periodontal probe in millimeters

Secondary

MeasureTime frameDescription
lip translationDay 0 - Month 3 - Month 6measured using a periodontal probe in millimeters
profile angleDay 0 - Month 6lateral cephalometric xray
lip lengthDay 0 - Month 3 - Month 6measured using a periodontal probe in millimeters
patient satisfactionDay 7measured by a binary Questionnaire ( yes or no)
Post operative painDay 7Measured by the visual analogue scale ( 0 no pain, 10 worst pain)
blinded esthetic assessmentMonth 3- Month 6measured by a binary scale (yes or no)

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026