3D Printed Implant for Management of Gummy Smile Through VISTA Technique (NCT06473805) | Clinical Trial Compass
Not Yet RecruitingPhase 3
3D Printed Implant for Management of Gummy Smile Through VISTA Technique
Egypt20 participantsStarted 2024-09-01
Plain-language summary
the most important esthetic concern for dental patients is excessive display of gingiva during smiling due to multiple causes e.g. hyperplasia of gingival, skeletal overgrowth of the anterior maxilla, altered passive eruption, maxillary alveolar tooth extrusion, short lip and lip hypermobility therefore accurate diagnosis of these factors is essential before treatment to ensure the most suitable approach is chosen. Maxillary overgrowth may cause sub nasal skeletal depression that lead to retraction of upper lip during smiling, causing gingiva display. The aim of this study is to describe an alternative technique to treat gingival smile with minimally invasive vestibular incision subperiosteal tunnel access (VISTA) to place 3D printed polymethylmethacrylate (PMMA)-based bone cement versus polyether ether ketone (PEEK) for lip repositioning.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients having excessive gingival display ≥ 4 mm.
* Clinically diagnosed and radiographically confirmed maxillary subnasal depression.
* Good compliance with the plaque control instructions following therapy.
* Availability for follow-up and maintenance program.
Exclusion Criteria:
* Smokers.
* Pregnant and lactating females.
* Patients with insufficient keratinized gingiva.
* Patients who had done any surgical procedure in the same region.
* Patients who had done fixed or removable prostheses in any anterior maxillary teeth.
* patients currently using medications linked to gingival hyperplasia.
* Systemic diseases that could affect the outcome of the therapy (according to the modified Burkett's health history questionnaire).
* Vulnerable groups of patients' e.g. (handicapped patients).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To measure amount of gingival display in different follow-up intervals
Timeframe: at 1, 3, 6 and 12 months postoperatively