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Not yet recruitingNCT07874022Updated Oct 14, 2026

Decision Regret Following Yonsei-Point Botulinum Toxin for Gummy Smile

An observational study in Excessive Gingival Display, sponsored by Cairo University. Not yet recruiting at 2 sites in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by Cairo University · Observational

Updated Oct 14, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
32
Ages
18 Years and older
Sex
All
01

Study summary

This study evaluates patient-reported decision regret in adult patients who previously received standardized Botulinum Toxin Type A (BoNT-A) injection at the Yonsei Point for excessive gingival display (gummy smile).

While BoNT-A provides predictable millimetric reduction in gingival exposure, subjective patient satisfaction and cognitive-emotional remorse remain under-investigated in periodontal plastic literature.

Eligible patients will be identified from hospital treatment records at Cairo University Faculty of Dentistry. Patient-reported decision regret will be measured at 3 months post-treatment using the Ottawa Decision Regret Scale (ODRS). Archived clinical and photogrammetric smile records will also be audited to evaluate gingival display reduction in millimeters.

Read the detailed description

BACKGROUND AND RATIONALE:

Excessive gingival display (EGD) is a common esthetic concern affecting approximately 10% to 13% of young adults. Upper lip elevator muscle hyperactivity is a primary etiology optimally treated with targeted neuromodulation. While standardized injection protocols such as the Yonsei Point (convergence of LLSAN, LLS, and ZMi muscles) yield consistent millimetric descent of the upper lip, clinical success does not always guarantee high patient satisfaction or absence of decision regret. Decision regret reflects negative cognitive-emotional remorse experienced after healthcare choices.

OBJECTIVES:

Primary Objective: To quantify patient-reported decision regret using the validated Ottawa Decision Regret Scale (ODRS) at 3 months post-treatment in adult patients who received Yonsei-point BoNT-A injection.

Secondary Objective: To measure photogrammetric gingival display reduction (mm) and evaluate its correlation with decision regret scores.

STUDY DESIGN AND METHODOLOGY:

This is a single-arm retrospective observational study combining a chart audit with a participant survey.

  1. Selection \& Identification: Clinical treatment logs at the Department of Periodontology, Cairo University, will be audited to identify patients aged >=18 years who underwent standardized Yonsei-point BoNT-A injection for hyperfunctional EGD (>=3 mm baseline exposure) and have complete baseline and 3-month post-treatment photographic files.
  2. Participant Recall \& Survey: Eligible participants will be contacted via telephone or scheduled follow-up visits. Upon obtaining informed consent, participants will complete the Ottawa Decision Regret Scale (ODRS; continuous score 0-100, where 0 represents no regret and 100 represents high regret).
  3. Image Analysis: Archived standardized smile photographs will undergo digital photogrammetric analysis to calculate gingival display reduction in millimeters.

DATA PROTECTION:

All extracted clinical data and survey responses will be de-identified using unique alphanumeric codes to maintain complete confidentiality.

02

Conditions studied

  • Excessive Gingival Display

Keywords

  • Botulinum Toxin Type A
  • Yonsei Point
  • Decision Regret
  • Ottawa Decision Regret Scale
  • Gummy Smile
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,909 studies on the registry; 1,445 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Browse Cairo University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with excessive gingival display associated with upper lip hyperactivity who received standardized Botulinum Toxin Type A (BoNT-A) injection at the Yonsei point at the Faculty of Dentistry, Cairo University.

Eligibility criteria

Inclusion Criteria:- Adult patients aged 18 years or older.

  • Patients diagnosed with excessive gingival display (>=3 mm exposure during maximum smile) due to upper lip hyperactivity.
  • Patients who previously received standardized Botulinum Toxin Type A (BoNT-A) injection at the Yonsei point.
  • Presence of complete baseline and 3-month post-treatment clinical and photographic records.

Exclusion Criteria:

  • Patients with vertical maxillary excess (VME) or altered passive eruption as the primary etiology of gummy smile.
  • Patients who underwent concomitant periodontal plastic surgery or lip repositioning.
  • Patients with a history of neuromuscular disorders (e.g., Myasthenia Gravis).
  • Pregnant or lactating females at the time of treatment.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
32 participants (estimated)
Patient registry
No

Groups and cohorts

  • Yonsei-point BoNT-A Cohort

    Adult patients (aged ≥18 years) with excessive gingival display associated with upper lip hyperactivity who previously received standardized Botulinum Toxin Type A injection at the Yonsei Point.

    Drug: Botulinum Toxin Type A injection at Yonsei Point

Interventions

  • DrugBotulinum Toxin Type A injection at Yonsei Point

    Standardized injection of Botulinum Toxin Type A targeted at the Yonsei point (the center of a triangle formed by levator labii superioris alaeque nasi, levator labii superioris, and zygomaticus minor muscles) for the management of excessive gingival display.

06

What researchers measure

Primary outcomes

  1. Patient-Reported Decision Regret Score

    Measured using the Ottawa Decision Regret Scale (ODRS). The scale consists of 5 items rated on a 5-point Likert scale, converted to a standardized score ranging from 0 (no regret) to 100 (high regret).

    Time frame: 3 months post-treatment

Secondary outcomes

  1. Reduction in Gingival Display

    Change in upper lip height / gingival exposure measured in millimeters (mm) using photogrammetric analysis of standardized digital photographs.

    Time frame: 3 months post-treatment (compared to baseline)

07

Study locations

2 sites
  • Faculty of Dentistry, Cairo University
    Cairo, Cairo Governorate, Egypt
  • Faculty of Dentistry, Cairo University
    Cairo, Egypt
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared to protect patient confidentiality and institutional data privacy protocols.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Jan 2027, 2 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2026
First posted
Oct 14, 2026
StartEst.
Nov 2026
Primary completionEst.
Jan 2027
CompletionEst.
Feb 2027
Last update
Oct 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07874022
Lead sponsor
Cairo University
Responsible party
Maie Ismaiel mohammed Fathy (Lecturer of Periodontology, Department of Periodontology, Faculty of Dentistry, Cairo University, Cairo University) — Principal investigator
First posted
Oct 14, 2026
Start date
Nov 2026 (estimated)
Primary completion
Jan 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Oct 14, 2026

Study contacts

Maie Ismaiel, LECTURER
Contact
maie.ismaiel@dentistry.cu.edu.eg
+201000020203

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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