Gummy SmileNCT06983262
Comparative Evaluation of Milled Polyether Ether Ketone (PEEK) Stent Placement and Lip Repositioning Surgery on the Treatment of Gummy Smile
A study testing Milled PEEK Stent and Lip repositioning surgery in people with Gummy Smile, run by taher helmy ismail metwaly at 1 site in Egypt.
Trial summary
The objective of this study is to compare between a Polyether ether ketone (PEEK) stent - and standard lip repositioning technique for management of gummy smile Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gummy Smile
- What is being tested?
- Milled PEEK Stent and Lip repositioning surgery
- 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
- 14 Feb 2024to 10 Apr 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systemically healthy individuals
- Chiefs complain gummy smile
- Gummy smile due to short hypermobile upper lip
- Gingival Display not more than 5 mm
Who cannot join
- Pregnancy
- Lactation
- History of smoking more than 10 cigarettes per day
- Systemic conditions or intake of medications that could affect soft and hard tissue healing
- Use of orthodontic appliances
- Gingival display above 5mm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Evaluation of Milled Polyether Ether Ketone (PEEK) Stent Placement and Lip Repositioning Surgery on the Treatment of Gummy Smile (A Randomized Controlled Clinical Trial)
The objective of this study is to compare between a Polyether ether ketone (PEEK) stent - and standard lip repositioning technique for management of gummy smile
- Conditions
- Gummy Smile
- Being tested
- Milled PEEK Stent, Lip repositioning surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Milled PEEK StentOther
A CBCT will be performed to assess the anatomy of the subnasal area and plan the position, size, shape and thickness of the PEEK Stent. These data will be transferred to a 3D planning software to generate a digital model. Eventually, the PEEK stents will be milled in a milling machine and sterilized in ethylene oxide before the surgery. Local anesthesia will be administered into the vestibular mucosa along the extension of the anterior maxilla. VISTA technique begins with a vestibular access incision in the midline frenum and 2 bilateral incisions at premolar area. A periosteal elevator will be introduced through the incision and inserted between the bone and periosteum to elevate the tissue, creating a subperiosteal tunnel, extending distally based on the dynamic of the smile. The PEEK stent will be in one piece. They will be placed onto the bone and stabilized with 2 bone graft screw for each side. The midline incision and the lateral incisions will be sutured primarily.
Lip repositioning surgeryProcedure or surgery
Profound anaesthesia will be achieved. A marking pencil§ will be used to outline the apical, coronal, and lateral boundaries of the elliptical incision. The coronal boundary will be at the mucogingival junction and will be used as a reference point to mark the apical boundary at two times the amount of gingival display. The coronal and apical incisions will be parallel to each other, and the apical incision gradually angled downward to meet the coronal incision. A partial thickness dissection will be made. The epithelium will be excised, exposing the underlying connective tissue. The mucosal flap will be advanced and sutured at the mucogingival junction.
| Study group | Role | What they receive |
|---|---|---|
| VISTA and Milled PEEK stent | Experimental | Not described Receives: Other: Milled PEEK Stent |
| Lip repositioning surgery | Active comparator | Not described Receives: Procedure: Lip repositioning surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain assessment
Postoperative pain will be evaluated at first and seventh day using numeric rating scale (NRS). Patient will rate his pain on a scale from 0 to 10, with 0 indicating no pain and 10 reflecting the worst possible pain.
- 0 = no pain
- 1-3 = mild pain
- 4-6 = moderate pain
- 7-10 = severe pain
Measured: up to one week
Facial Edema (Swelling)
Postoperative edema was measured with a flexible tape measure by calculating the distance between several facial landmarks and comparing them to preoperative values.
Measured: up to one week
Healing Quality
Measured according to Landry's Healing Index which records healing on basis of tissue colour, bleeding, ulceration, granulation tissue and epithelisation.
Scores range from 1 (Very poor) to 5 (excellent)
Measured: up to 3 weeks
Gingival display
Distance from gingival margin to lower border of upper lip vermilion border will be measured
Measured: up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start14 Feb 2024
- Primary completion10 Apr 2025
- Study completion10 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gummy SmileStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- taher helmy ismail metwaly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, taher helmy ismail metwaly, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983262
- Sponsor's protocol ID
- 1/3-2024
- Status last verified
- Jul 2026
- First submitted
- 4 Mar 2025
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Milled Polyether Ether Ketone (PEEK) Stent Placement and Lip Repositioning Surgery on the Treatment of Gummy Smile (A Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT06983262
- Acronym / sponsor ID
- 1/3-2024
- Conditions
- Gummy Smile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- taher helmy ismail metwalyUniversity, hospital or other
- Study start
- 14 Feb 2024 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 10 Apr 2025 (actual)
- First posted
- 21 May 2025 (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.
The objective of this study is to compare between a Polyether ether ketone (PEEK) stent - and standard lip repositioning technique for management of gummy smile
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VISTA and Milled PEEK stent | Experimental | Other: Milled PEEK Stent |
| Lip repositioning surgery | Active comparator | Procedure: Lip repositioning surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Systemically healthy individuals
- Chiefs complain gummy smile
- Gummy smile due to short hypermobile upper lip
- Gingival Display not more than 5 mm
Key exclusion criteria (6 listed)
- Pregnancy
- Lactation
- History of smoking more than 10 cigarettes per day
- Systemic conditions or intake of medications that could affect soft and hard tissue healing
- Use of orthodontic appliances
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 |
|---|---|---|
| Milled PEEK StentA CBCT will be performed to assess the anatomy of the subnasal area and plan the position, size, shape and thickness of the PEEK Stent. These data will be transferred to a 3D planning software to generate a digital model. Eventually, the PEEK stents will be milled in a milling machine and sterilized in ethylene oxide before the surgery. Local anesthesia will be administered into the vestibular mucosa along the extension of the anterior maxilla. VISTA technique begins with a vestibular access incision in the midline frenum and 2 bilateral incisions at premolar area. A periosteal elevator will be introduced through the incision and inserted between the bone and periosteum to elevate the tissue, creating a subperiosteal tunnel, extending distally based on the dynamic of the smile. The PEEK stent will be in one piece. They will be placed onto the bone and stabilized with 2 bone graft screw for each side. The midline incision and the lateral incisions will be sutured primarily. | Other | VISTA and Milled PEEK stent |
| Lip repositioning surgeryProfound anaesthesia will be achieved. A marking pencil§ will be used to outline the apical, coronal, and lateral boundaries of the elliptical incision. The coronal boundary will be at the mucogingival junction and will be used as a reference point to mark the apical boundary at two times the amount of gingival display. The coronal and apical incisions will be parallel to each other, and the apical incision gradually angled downward to meet the coronal incision. A partial thickness dissection will be made. The epithelium will be excised, exposing the underlying connective tissue. The mucosal flap will be advanced and sutured at the mucogingival junction. | Procedure or surgery | Lip repositioning surgery |
Primary outcome
Postoperative pain assessment
Time frame: up to one week
Postoperative pain will be evaluated at first and seventh day using numeric rating scale (NRS). Patient will rate his pain on a scale from 0 to 10, with 0 indicating no pain and 10 reflecting the worst possible pain. * 0 = no pain * 1-3 = mild pain * 4-6 = moderate pain * 7-10 = severe pain
Facial Edema (Swelling)
Time frame: up to one week
Postoperative edema was measured with a flexible tape measure by calculating the distance between several facial landmarks and comparing them to preoperative values.
Healing Quality
Time frame: up to 3 weeks
Measured according to Landry's Healing Index which records healing on basis of tissue colour, bleeding, ulceration, granulation tissue and epithelisation. Scores range from 1 (Very poor) to 5 (excellent)
Gingival display
Time frame: up to 9 months
Distance from gingival margin to lower border of upper lip vermilion border will be measured
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 13 Jul 2026.
Related trials for Gummy Smile
Not yet recruiting
Accuracy of Stackable Double Periodontal Guide in Esthetic Crown Lengthening
Gummy Smile of Altered Passive Eruption Type 1B
Not yet recruitingObservational study
Decision Regret Following Yonsei-Point Botulinum Toxin for Gummy Smile
Excessive Gingival Display
Recruiting
Periodontal Tissue Stability After Surgical Correction of Altered Passive Eruption
Altered Passive Eruption
RecruitingObservational study
Evaluating AI for Diagnosing and Treating Gummy Smiles: A Pilot Study
Gummy Smile, Artifical Intelligence
RecruitingObservational study
Gummy Smile and Altered Passive Eruption Prevalence
Altered Passive Eruption of Teeth
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 Milled PEEK Stent and Lip repositioning surgery in people with Gummy Smile, run by taher helmy ismail metwaly 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 4 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 13 Jul 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?
Postoperative pain assessment (time frame: up to one week). The study lists 4 primary outcomes in all. 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 13 Jul 2026.