New 3D-Printed implant may fix gummy smiles without major surgery
NCT ID NCT06017791
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested a custom 3D-printed PEEK shell placed under the gum in the upper jaw to reduce excessive gum display (gummy smile) in 10 patients. The shell was inserted through small incisions using a tunnel technique. The goal was to see if it could decrease the amount of gum showing when smiling, while also measuring pain, lip movement, and patient satisfaction.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 3D-printed PEEK shell placed via tunnel technique
- What this could lead to
- If successful, this could offer a new, minimally invasive option to reduce a gummy smile without major surgery.
- What could go wrong
- This is a very small case series (10 people) with no control group, so results may not apply to everyone. Long-term safety and effectiveness are not yet known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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10 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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Jan 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
20 to 60 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Farah Mamdouh
Cairo, 11835, Egypt
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New lip surgery shows promise for gummy smile fix