Excessive Gingival DisplayNCT07334015
Treatment of Excessive Gingival Display (Lip Repositioning and Z Plasty)
A study testing z plasty frenectomy and Modified lip repositioning in people with Excessive Gingival Display, run by Suez Canal University at 1 site in Egypt.
Trial summary
evaluate clinically the postoperative outcomes of the Z plasty frenectomy technique in comparison to modified lip repositioning surgery Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Excessive Gingival Display
- What is being tested?
- z plasty frenectomy and Modified lip repositioning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2024to 30 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female patients aged 18 to 30 years
- ASA physical status I or II
- Presence of excessive gingival display (gummy smile)
- Indication for surgical treatment of excessive gingival display
- Willingness to participate and attend follow-up visits
Who cannot join
- Poor oral hygiene
- Patients with active acute infection
- Patients with poor oral habits
- Pregnant or lactating women
- Heavy smokers
- Alcohol or drug addicts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Modified Lip Repositioning Surgery and Z Plasty Frenectomy for Treatment of Excessive Gingival Display
evaluate clinically the postoperative outcomes of the Z plasty frenectomy technique in comparison to modified lip repositioning surgery
Read the detailed description
Excessive gingival display is a cosmetic problem where it is usually managed by different approaches such as lip repositioning.
Aim: Is to evaluate clinically the postoperative outcomes of the Z plasty frenectomy technique in comparison to modified lip repositioning surgery Methodology: The clinical study will include 16 patients with gummy smile divided into two groups equally and randomly according to technique using www.randomizer.org.
Group 1: will be treated with conventional modified lip repositioning technique and the labial frenum will be left intact.
Group 2: will be treated with z plasty frenectomy. Clinical follow up will be at 1,3, 6 and 9 months.
Clinical evaluation will be done through using (VAS). It will be used to measure patient satisfaction through pain killer scale . - Likert scale to measure patient satisfaction - Periodontal probe will be used to measure the relapse. Also signs of infection will be recorded.
- Conditions
- Excessive Gingival Display
- Being tested
- z plasty frenectomy, Modified lip repositioning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
z plasty frenectomyProcedure or surgery
Also called Z Plasty
Z-plasty frenectomy is a surgical procedure in which the frenum is released and rearranged using a Z-shaped incision. This technique helps improve tissue mobility and reduce tension. The procedure is performed under local anesthesia"
Modified lip repositioningProcedure or surgery
Also called lip repositioning, gummy smile
"Modified lip repositioning is a minimally invasive surgical technique used to reduce excessive gingival display. The procedure involves removing a small strip of mucosa and repositioning the upper lip to limit its upward movement during smiling. It is performed under local anesthesia ."
| Study group | Role | What they receive |
|---|---|---|
| study group: z plasty frenectomy | Experimental | Participants in the study group will be treated with Z- plasty frenectomy and will be followed up for 9 months Receives: Procedure: z plasty frenectomy |
| control group : modified lip repositioning | Experimental | Participants in the control group will undergo modified lip repositioning with a follow-up period of 9 months. Receives: Procedure: Modified lip repositioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gingival Display (mm)
Gingival display will be assessed in millimeters using standardized clinical photographs taken at maximum smile. Measurements will be performed using a periodontal probe to determine the vertical distance between the inferior border of the upper lip and the gingival margin of the maxillary central incisors. A reduction in gingival display indicates improvement, while an increase indicates relapse. Measurements will be recorded at baseline and during follow-up visits.
Measured: Up to 9 months
Secondary outcomes (4)
Pain score
Postoperative pain will be assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Lower scores indicate less pain.
Measured: Up to 9 months
Patient Satisfaction Score
Patient satisfaction will be evaluated using a numerical rating scale from 0 to 10, where 0 indicates complete dissatisfaction and 10 indicates maximum satisfaction. Higher scores indicate greater satisfaction.
Measured: Up to 9 months
Signs of infection
Postoperative infection will be assessed clinically based on the presence of signs such as redness, swelling, pain, discharge, or delayed healing at the surgical site. The outcome will be recorded as present or absent.
Measured: Up to 9 months
Surgical Time
Surgical time will be measured in minutes from the initial incision to the completion of wound closure. Shorter surgical time indicates a more efficient procedure.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start10 Sep 2024
- Primary completion19 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Excessive Gingival DisplayStudies of the same condition, open and under way.
- More trials run by Suez Canal 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups 16 patient in each group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leen somaf, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334015
- Sponsor's protocol ID
- 2024/857
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tatakis DN. Lip Repositioning Techniques and Modifications. Dent Clin North Am. 2022 Jul;66(3):373-384. doi: 10.1016/j.cden.2022.02.002. Epub 2022 Jun 1.
PubMed 35738733
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Modified Lip Repositioning Surgery and Z Plasty Frenectomy for Treatment of Excessive Gingival Display
- ClinicalTrials.gov ID
- NCT07334015
- Acronym / sponsor ID
- 2024/857
- Conditions
- Excessive Gingival Display
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 19 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 12 Jan 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.
evaluate clinically the postoperative outcomes of the Z plasty frenectomy technique in comparison to modified lip repositioning surgery
Detailed description
Excessive gingival display is a cosmetic problem where it is usually managed by different approaches such as lip repositioning.
Aim: Is to evaluate clinically the postoperative outcomes of the Z plasty frenectomy technique in comparison to modified lip repositioning surgery Methodology: The clinical study will include 16 patients with gummy smile divided into two groups equally and randomly according to technique using www.randomizer.org.
Group 1: will be treated with conventional modified lip repositioning technique and the labial frenum will be left intact.
Group 2: will be treated with z plasty frenectomy. Clinical follow up will be at 1,3, 6 and 9 months.
Clinical evaluation will be done through using (VAS). It will be used to measure patient satisfaction through pain killer scale . - Likert scale to measure patient satisfaction - Periodontal probe will be used to measure the relapse. Also signs of infection will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2 groups 16 patient in each group
| Arm | Type | Receives |
|---|---|---|
| study group: z plasty frenectomy | Experimental | Procedure: z plasty frenectomyParticipants in the study group will be treated with Z- plasty frenectomy and will be followed up for 9 months |
| control group : modified lip repositioning | Experimental | Procedure: Modified lip repositioningParticipants in the control group will undergo modified lip repositioning with a follow-up period of 9 months. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Female patients aged 18 to 30 years
- ASA physical status I or II
- Presence of excessive gingival display (gummy smile)
- Indication for surgical treatment of excessive gingival display
- Willingness to participate and attend follow-up visits
Key exclusion criteria (6 listed)
- Poor oral hygiene
- Patients with active acute infection
- Patients with poor oral habits
- Pregnant or lactating women
- Heavy smokers
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 |
|---|---|---|
| z plasty frenectomyAlso: Z PlastyZ-plasty frenectomy is a surgical procedure in which the frenum is released and rearranged using a Z-shaped incision. This technique helps improve tissue mobility and reduce tension. The procedure is performed under local anesthesia" | Procedure or surgery | study group: z plasty frenectomy |
| Modified lip repositioningAlso: lip repositioning, gummy smile"Modified lip repositioning is a minimally invasive surgical technique used to reduce excessive gingival display. The procedure involves removing a small strip of mucosa and repositioning the upper lip to limit its upward movement during smiling. It is performed under local anesthesia ." | Procedure or surgery | control group : modified lip repositioning |
Primary outcome
Change in Gingival Display (mm)
Time frame: Up to 9 months
Gingival display will be assessed in millimeters using standardized clinical photographs taken at maximum smile. Measurements will be performed using a periodontal probe to determine the vertical distance between the inferior border of the upper lip and the gingival margin of the maxillary central incisors. A reduction in gingival display indicates improvement, while an increase indicates relapse. Measurements will be recorded at baseline and during follow-up visits.
4 secondary outcomes
Pain score
Time frame: Up to 9 months
Patient Satisfaction Score
Time frame: Up to 9 months
Signs of infection
Time frame: Up to 9 months
Surgical Time
Time frame: During surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
- Background: PubMed 35738733Tatakis DN. Lip Repositioning Techniques and Modifications. Dent Clin North Am. 2022 Jul;66(3):373-384. doi: 10.1016/j.cden.2022.02.002. Epub 2022 Jun 1.
- Reference describing the modified lip repositioning surgical technique used to reduce excessive gingival display in gummy smile patients.Link provided by the sponsor.
- Study explaining the use of Z-plasty for lengthening the upper lip and improving esthetic outcomes in cases of excessive gingival display.Link provided by the sponsor.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing z plasty frenectomy and Modified lip repositioning in people with Excessive Gingival Display, run by Suez Canal University at 1 site 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Gingival Display (mm) (time frame: Up to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07334015, which also lists 1 linked publication.
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 12 Jan 2026.