NCT06017791

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 17, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 30, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

November 8, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 7, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2026

Completed
Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

2.2 years

First QC Date

August 17, 2023

Last Update Submit

March 19, 2026

Conditions

Excessive Gingival Display

Outcome Measures

Primary Outcomes (1)

  • Gingival display

    measured using a periodontal probe in millimeters

    Day 0 - Month 3 - Month 6

Secondary Outcomes (6)

  • lip translation

    Day 0 - Month 3 - Month 6

  • profile angle

    Day 0 - Month 6

  • lip length

    Day 0 - Month 3 - Month 6

  • patient satisfaction

    Day 7

  • Post operative pain

    Day 7

  • +1 more secondary outcomes

Study Arms (1)

PEEK shell in the anterior maxilla inserted by tunnel technique

EXPERIMENTAL

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

Interventions

tunnel technique with a 3D printed PEEK shell to fill the skeletal subnasal depressionOTHER

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

PEEK shell in the anterior maxilla inserted by tunnel technique

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnant and lactating females
  • Smokers
  • Diabetics
  • Patients with parafunctional habits that may affect the outcome of the procedure
  • Medically compromised patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Farah Mamdouh

Cairo, 11835, Egypt

Location

Related Publications (10)

  • Brizuela M, Ines D. Excessive Gingival Display. 2023 Mar 19. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK470437/

    PMID: 29262052BACKGROUND

  • El-Bokle, Dalia & Ghany, Amany. (2022). A sequential diagnostic scheme for excessive gingival display (Gummy Smile). AJO-DO Clinical Companion. 2. 10.1016/j.xaor.2022.05.003

    BACKGROUND

  • Impellizzeri A, Palmigiani R, Horodynski M, D'alfonso T, Polimeni A, De Stefano A, Galluccio G. Is There a Correlation between Gingival Display and Incisal Inclination in a Gummy Smile? Study on Cephalometric Parameters. Healthcare (Basel). 2023 Jan 25;11(3):344. doi: 10.3390/healthcare11030344.

    PMID: 36766919BACKGROUND

  • Monaco A, Streni O, Marci MC, Marzo G, Gatto R, Giannoni M. Gummy smile: clinical parameters useful for diagnosis and therapeutical approach. J Clin Pediatr Dent. 2004 Fall;29(1):19-25. doi: 10.17796/jcpd.29.1.y01l3r4m06q3k2x0.

    PMID: 15554398BACKGROUND

  • Toth, J. M. (2012). Biocompatibility of Polyaryletheretherketone Polymers. PEEK Biomaterials Handbook, 81-92. doi:10.1016/b978-1-4377-4463-7.10007-7

    BACKGROUND

  • Freitas de Andrade P, Meza-Mauricio J, Kern R, Faveri M. Labial Repositioning Using Print Manufactured Polymethylmethacrylate- (PMMA-) Based Cement for Gummy Smile. Case Rep Dent. 2021 Dec 21;2021:7607522. doi: 10.1155/2021/7607522. eCollection 2021.

    PMID: 34970460BACKGROUND

  • Labial repositioning using polymethylmethracylate (PMMA)-based cement for esthetic smile rehabilitation-A case report Toni Arcuri a, Maykson Feitosa Pereira da Costa b, Iury Machado Ribeiroa, Byron Daia Barreto Júnior b, João Paulo Lyra eSilvac,∗ a Department of Dentistry, Paulista University, UNIP, Brasília, Brazil b Private Office in Brasilia, Brazil c Department of Dentistry, Universitary Center Euro Americano, UNIEURO, Brasília, Brazil

    BACKGROUND

  • ASSENZA, B. & Carinci, Francesco & CRISTINZI, A. & Sinjari, Bruna & Murmura, Giovanna & Scarano, Antonio. (2011). A COSMETIC TECHNIQUE CALLED LIP REPOSITIONING IN PATIENT OF EXCESSIVE GINGIVAL DISPLAY. European Journal of Inflammation. 9. 115-119.

    BACKGROUND

  • Dym H, Pierre R 2nd. Diagnosis and Treatment Approaches to a "Gummy Smile". Dent Clin North Am. 2020 Apr;64(2):341-349. doi: 10.1016/j.cden.2019.12.003. Epub 2020 Jan 24.

    PMID: 32111273BACKGROUND

  • Saleem R, Kukreja BJ, Goyal M, Kumar M. Treating short upper lip with "Unified lip repositioning" technique: Two case reports. J Indian Soc Periodontol. 2022 Jan-Feb;26(1):89-93. doi: 10.4103/jisp.jisp_90_20. Epub 2022 Jan 1.

    PMID: 35136324BACKGROUND

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

August 17, 2023

First Posted

August 30, 2023

Study Start

November 8, 2023

Primary Completion

January 7, 2026

Study Completion

January 7, 2026

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, CSR
Time Frame
2025

Locations

EG(1)