Excessive Gingival DisplayNCT07874022
Decision Regret Following Yonsei-Point Botulinum Toxin for Gummy Smile
An observational study of Excessive Gingival Display, run by Cairo University at 2 sites in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Excessive Gingival Display
- What is being tested?
- Botulinum Toxin Type A injection at Yonsei Point
- Type of treatment
- Injection or infusion
- How many people
- 32 participants
- Where
- 2 sitesEgypt
- Study dates
- Nov 2026to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites
Faculty of Dentistry, Cairo University
Cairo, Cairo Governorate
Maie Ismaiel, lecturer, +201000020203, maie.ismaiel@dentistry.cu.edu.eg
Maie Ismaiel
Faculty of Dentistry, Cairo University
Cairo
About this study
Official title: Beyond Clinical Correction: Patient-Reported Decision Regret Following Yonsei-Point Botulinum Toxin Type A Injection for Excessive Gingival Display
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.
- 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.
- 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).
- 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.
- Conditions
- Excessive Gingival Display
- Being tested
- Botulinum Toxin Type A injection at Yonsei Point
- Keywords
- Botulinum Toxin Type A, Yonsei Point, Decision Regret, Ottawa Decision Regret Scale, Gummy Smile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum Toxin Type A injection at Yonsei PointDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Botulinum Toxin Type A injection at Yonsei Point |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 3 months post-treatment (compared to baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive Gingival DisplayStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maie Ismaiel mohammed Fathy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874022
- Sponsor's protocol ID
- CUDENT-PERIO-2026-ODRS
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect patient confidentiality and institutional data privacy protocols.
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Beyond Clinical Correction: Patient-Reported Decision Regret Following Yonsei-Point Botulinum Toxin Type A Injection for Excessive Gingival Display
- ClinicalTrials.gov ID
- NCT07874022
- Acronym / sponsor ID
- CUDENT-PERIO-2026-ODRS
- Conditions
- Excessive Gingival Display
- Keywords
- Botulinum Toxin Type A, Yonsei Point, Decision Regret, Ottawa Decision Regret Scale, Gummy Smile
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 14 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- 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.
- 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).
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Yonsei-point BoNT-A Cohort | – | Drug: Botulinum Toxin Type A injection at Yonsei PointAdult 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum Toxin Type A injection at Yonsei PointStandardized 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. | Drug | Yonsei-point BoNT-A Cohort |
Primary outcome
Patient-Reported Decision Regret Score
Time frame: 3 months post-treatment
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).
1 secondary outcome
Reduction in Gingival Display
Time frame: 3 months post-treatment (compared to baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect patient confidentiality and institutional data privacy protocols.
Related trials for Excessive Gingival Display
Enrolling by invitation
Can Adjunctive Oral Magnesium Supplementation Prolong the Effect of Botulinum Toxin Type A in Excessive Gingival Display?
Magnesium, Botulinum Toxin Type A
Recruiting
Periodontal Tissue Stability After Surgical Correction of Altered Passive Eruption
Altered Passive Eruption
Active, not recruiting
Effect of Botox Before Modified Lip Repositioning Repositioning Only in Relapse of the Excessive Gingival Display Within One Year
Excessive Gingival Display
Recruiting
Comparison Between Liquid Fibrin and Soft Laser Effects on Healing and Relapse After Lip Repositioning Surgery
Gummy Smile
Recruiting
EMG-guided Botox Injection Versus Conventional Botox Injection in Gummy Smile Patients
Excessive Gingival Display
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Excessive Gingival Display, run by Cairo University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maie Ismaiel, LECTURER (+201000020203, maie.ismaiel@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Decision Regret Score (time frame: 3 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.