Management of Gummy SmilePhase 3VISTANCT06473805
3D Printed Implant for Management of Gummy Smile Through VISTA Technique
A Phase 3 study testing VISTA technique and 3D printed PMMA implant and VISTA technique and 3D printed PEEK implant in people with Management of Gummy Smile, run by Ain Shams University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Management of Gummy Smile
- What is being tested?
- VISTA technique and 3D printed PMMA implant and VISTA technique and 3D printed PEEK implant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2024to 1 Jan 2026
- Phase
- Phase 3
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3D Printed Polymethylmethacrylate Versus Polyether Ether Ketone Implant for Management of Gummy Smile Through VISTA Technique: A Randomized Clinical Study
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.
Read the detailed description
A smile plays an important role in determining a person's initial impression and its assessment has become integral to clinical evaluation owing to how appealing a smile could be among people. A gingival smile, gummy smile or high smile line is an aesthetic concern with 10-12% prevalence among dental patients mainly in women and is diagnosed when a patient shows ≥3 mm of free gingiva.
A gummy smile may result from a single cause but is more commonly found to be the result of an interplay of multiple factors and identifying the causative factor is the basis for its treatment. It may be broadly caused by dentoalveolar discrepancies or non-dentoalveolar discrepancies. Dentoalveolar discrepancies include short clinical crowns, altered passive eruption and gingival hypertrophy/hyperplasia. These discrepancies can be improved by restorative and periodontal approaches. Non-dentoalveolar discrepancies include hyperactive upper lip, short, or incompetent upper lip and vertical maxillary excess. Orthognathic surgery, lip repositioning (LRT), orthodontic treatment, and Botox injections are the main treatment modalities typically employed for treating thesis conditions.
LRT, first described by Kostianovsky and Rubinstein in 1976, has shown excellent efficacy in treating gummy smile, showing an average reduction of 2.71 to 3.4 mm at 6 months of follow-up in previous systematic reviews. However, the traditional technique has reported different partial or complete degrees of relapse. Therefore, different modifications have been developed to improve the predictability and stability of the technique and reduce morbidity and complications.
Most modifications reported in the last 5 years aim to provide improved stability of outcome by introducing techniques that eliminate or restrict the function of the muscles responsible for raising the upper lip during smile or that alter/restrict the hypermobility of lip movement. Some of these techniques include the use of adjuvants such as botulinum toxin (BOTOX).
Injecting overactive muscles with measured amount of botulinum toxin results in a reduction of muscle activity, relaxation of the lip muscles and decreasing upward pull on the lip. The improvement achieved is almost immediate but remains only for a period of 3-6 months, before slowly fading. This relatively short duration is the major disadvantage of the technique, that require constant reapplication and the effects of long-term use of Botox have not been adequately researched
Other approaches, such as the incorporation of muscle resection or the introduction of polymethylmethacrylate (PMMA) implants are intended to have a permanent effect. PMMA is a cross-chain polymer material compatible with human tissues, and since World War II it has been utilized in medicine, for cranioplasties in neurosurgeries, secondary to decompressive craniectomy. It is still the most used reconstructive material by many clinicians because it is one of the most available biocompatible alloplastic materials that elicit low foreign body reaction and provide adequate protection to adjacent neural tissues. Its first application in dentistry was for full dentures and it has shown promising results such as good biocompatibility with the oral tissues.
PMMA bone cement can also be used as graft material for extraction sites, furcation lesions, correction of maxillary and mandibular contours and in 2017, Torres et al. published the first study in which PMMA was used for sub nasal depression in cases of vertical maxillary excess. To restore deficient thickness of alveolar bone and perform adequate lip support, PMMA was directly modified and adapted on the bone surface. Another study in 2018 and 2024, Conventional full thickness mucoperiosteal flaps had been used to obtain access to the labial alveolar bone surface, to place and secure the PMMA device with fixation screws.
To overcome intraoperative complication such as incomplete polymerization, exothermic reactions, low physical properties and prolonged operation time, a new approach using 3D print for the use of PMMA cement to decrease lip movement, reposition the upper lip and decrease the gingival exposure. In 2023, de Castro et al., described alternative technique to treat gummy smile with minimally invasive vestibular incision subperiosteal tunnel access (VISTA) and PMMA implants for lip repositioning. Although the published case reports have shown good outcomes for this specific indication, there is a need to better codify the indications for the procedure and to have stronger clinical evidence to support its use.
In addition to PMMA, Polyether ether ketone (PEEK) has become a hot topic for new material research due to its good biocompatibility, excellent fatigue properties, excellent mechanical properties, high toughness, relatively low wear rate, corrosion and aging resistance, ease of processing, and color stability. Additionally. Recently, 3D printing has been used to manufacture PEEK scaffolds and prostheses. This technique can produce more precise and complex end products.
Considering its advantageous physical properties and the low rate of postoperative complications reported in the literature, PEEK is a reliable biomaterial for patient-specific implants in facial recontouring as has been described as part of reconstruction of skull defects and those in the orbital-maxillo-zygomatic district, both in post-traumatic and in post cancer situations. However, fewer reviews have provided a through summary about the recent advances in PEEK for a variety of dental applications.
Future research should focus on the impact of different materials of bone cement grafts whether PMMA or PEEK to manage the gingival smile in facial profile at rest and during smiling, thereby enabling the understanding of some of the possible side effects of this intervention.
- Conditions
- Management of Gummy Smile
- Being tested
- VISTA technique and 3D printed PMMA implant, VISTA technique and 3D printed PEEK implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VISTA technique and 3D printed PMMA implantProcedure or surgery
Also called minimally invasive vestibular incision subperiosteal tunnel access and 3D printed polymethylmethacrylate implant
Intraoral scanning and radiographic examination (CBCT) will be performed to assess the anatomy of the sub nasal area and plan the position, size and thickness of PMMA implant The data will be transferred to 3D planning software to create digital model that fit in the defect followed by 3D printing of the implant using VISTA technique
VISTA technique and 3D printed PEEK implantProcedure or surgery
Also called minimally invasive vestibular incision subperiosteal tunnel access and 3D printed Polyether ether ketone implant
Intraoral scanning and radiographic examination (CBCT) will be performed to assess the anatomy of the subnasal area and plan the position, size and thickness of PEEK implant The data will be transferred to 3D planning software to create digital model that fit in the defect followed by 3D printing of the implant using VISTA technique
| Study group | Role | What they receive |
|---|---|---|
| • Group I (3D printed PMMA implant spacer): | Active comparator | 10 patients with a gummy smile caused by excessive gingival display ≥ 4 mm due to subnasal depression will perform minimally invasive vestibular incision subperiosteal tunnel access (VISTA) and 3D printed PMMA implants. Receives: Procedure: VISTA technique and 3D printed PMMA implant |
| • Group II (3D printed PEEk implant spacer): | Active comparator | 10 patients with a gummy smile caused by excessive gingival display ≥ 4 mm due to subnasal depression will perform minimally invasive vestibular incision subperiosteal tunnel access (VISTA) and 3D printed PEEK implants. Receives: Procedure: VISTA technique and 3D printed PEEK implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure amount of gingival display in different follow-up intervals
To measure amount of gingival display in millimeters in different follow-up intervals.
Measured: at 1, 3, 6 and 12 months postoperatively
Secondary outcomes (2)
To evaluate patient satisfaction
To evaluate patient satisfaction by filling questionnaire
Measured: at 1, 3, 6 and 12 months postoperatively
to evaluate postoperative pain
to evaluate postoperative pain by visual analogue scale (from 0 to 10 score)
Measured: at 1, 3, 6 and 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Management of Gummy SmileStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients with a gummy smile caused by excessive gingival display ≥ 4 mm due to sub nasal depression will be randomly divided into 2 groups, each will perform minimally invasive vestibular incision subperiosteal tunnel access (VISTA) and place whether 3D printed PMMA or PEEK implants.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Zidan, Ain Shams University
- Investigators
- Hala A. Abuel Ela, Professor, Study director, Professor of Oral Medicine, Periodontology, Oral Diagnosis, Faculty of Dentistry, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06473805
- Sponsor's protocol ID
- FDASU-Rec ID052418
- Acronym
- VISTA
- Status last verified
- Jun 2024
- First submitted
- 19 Jun 2024
- Last updated
- 25 Jun 2024
- 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 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Printed Polymethylmethacrylate Versus Polyether Ether Ketone Implant for Management of Gummy Smile Through VISTA Technique: A Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06473805
- Acronym / sponsor ID
- VISTA / FDASU-Rec ID052418
- Conditions
- Management of Gummy Smile
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 25 Jun 2024 (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 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.
Detailed description
A smile plays an important role in determining a person's initial impression and its assessment has become integral to clinical evaluation owing to how appealing a smile could be among people. A gingival smile, gummy smile or high smile line is an aesthetic concern with 10-12% prevalence among dental patients mainly in women and is diagnosed when a patient shows ≥3 mm of free gingiva.
A gummy smile may result from a single cause but is more commonly found to be the result of an interplay of multiple factors and identifying the causative factor is the basis for its treatment. It may be broadly caused by dentoalveolar discrepancies or non-dentoalveolar discrepancies. Dentoalveolar discrepancies include short clinical crowns, altered passive eruption and gingival hypertrophy/hyperplasia. These discrepancies can be improved by restorative and periodontal approaches. Non-dentoalveolar discrepancies include hyperactive upper lip, short, or incompetent upper lip and vertical maxillary excess. Orthognathic surgery, lip repositioning (LRT), orthodontic treatment, and Botox injections are the main treatment modalities typically employed for treating thesis conditions.
LRT, first described by Kostianovsky and Rubinstein in 1976, has shown excellent efficacy in treating gummy smile, showing an average reduction of 2.71 to 3.4 mm at 6 months of follow-up in previous systematic reviews. However, the traditional technique has reported different partial or complete degrees of relapse. Therefore, different modifications have been developed to improve the predictability and stability of the technique and reduce morbidity and complications.
Most modifications reported in the last 5 years aim to provide improved stability of outcome by introducing techniques that eliminate or restrict the function of the muscles responsible for raising the upper lip during smile or that alter/restrict the hypermobility of lip movement. Some of these techniques include the use of adjuvants such as botulinum toxin (BOTOX).
Injecting overactive muscles with measured amount of botulinum toxin results in a reduction of muscle activity, relaxation of the lip muscles and decreasing upward pull on the lip. The improvement achieved is almost immediate but remains only for a period of 3-6 months, before slowly fading. This relatively short duration is the major disadvantage of the technique, that require constant reapplication and the effects of long-term use of Botox have not been adequately researched
Other approaches, such as the incorporation of muscle resection or the introduction of polymethylmethacrylate (PMMA) implants are intended to have a permanent effect. PMMA is a cross-chain polymer material compatible with human tissues, and since World War II it has been utilized in medicine, for cranioplasties in neurosurgeries, secondary to decompressive craniectomy. It is still the most used reconstructive material by many clinicians because it is one of the most available biocompatible alloplastic materials that elicit low foreign body reaction and provide adequate protection to adjacent neural tissues. Its first application in dentistry was for full dentures and it has shown promising results such as good biocompatibility with the oral tissues.
PMMA bone cement can also be used as graft material for extraction sites, furcation lesions, correction of maxillary and mandibular contours and in 2017, Torres et al. published the first study in which PMMA was used for sub nasal depression in cases of vertical maxillary excess. To restore deficient thickness of alveolar bone and perform adequate lip support, PMMA was directly modified and adapted on the bone surface. Another study in 2018 and 2024, Conventional full thickness mucoperiosteal flaps had been used to obtain access to the labial alveolar bone surface, to place and secure the PMMA device with fixation screws.
To overcome intraoperative complication such as incomplete polymerization, exothermic reactions, low physical properties and prolonged operation time, a new approach using 3D print for the use of PMMA cement to decrease lip movement, reposition the upper lip and decrease the gingival exposure. In 2023, de Castro et al., described alternative technique to treat gummy smile with minimally invasive vestibular incision subperiosteal tunnel access (VISTA) and PMMA implants for lip repositioning. Although the published case reports have shown good outcomes for this specific indication, there is a need to better codify the indications for the procedure and to have stronger clinical evidence to support its use.
In addition to PMMA, Polyether ether ketone (PEEK) has become a hot topic for new material research due to its good biocompatibility, excellent fatigue properties, excellent mechanical properties, high toughness, relatively low wear rate, corrosion and aging resistance, ease of processing, and color stability. Additionally. Recently, 3D printing has been used to manufacture PEEK scaffolds and prostheses. This technique can produce more precise and complex end products.
Considering its advantageous physical properties and the low rate of postoperative complications reported in the literature, PEEK is a reliable biomaterial for patient-specific implants in facial recontouring as has been described as part of reconstruction of skull defects and those in the orbital-maxillo-zygomatic district, both in post-traumatic and in post cancer situations. However, fewer reviews have provided a through summary about the recent advances in PEEK for a variety of dental applications.
Future research should focus on the impact of different materials of bone cement grafts whether PMMA or PEEK to manage the gingival smile in facial profile at rest and during smiling, thereby enabling the understanding of some of the possible side effects of this intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients with a gummy smile caused by excessive gingival display ≥ 4 mm due to sub nasal depression will be randomly divided into 2 groups, each will perform minimally invasive vestibular incision subperiosteal tunnel access (VISTA) and place whether 3D printed PMMA or PEEK implants.
| Arm | Type | Receives |
|---|---|---|
| • Group I (3D printed PMMA implant spacer): | Active comparator | Procedure: VISTA technique and 3D printed PMMA implant10 patients with a gummy smile caused by excessive gingival display ≥ 4 mm due to subnasal depression will perform minimally invasive vestibular incision subperiosteal tunnel access (VISTA) and 3D printed PMMA implants. |
| • Group II (3D printed PEEk implant spacer): | Active comparator | Procedure: VISTA technique and 3D printed PEEK implant10 patients with a gummy smile caused by excessive gingival display ≥ 4 mm due to subnasal depression will perform minimally invasive vestibular incision subperiosteal tunnel access (VISTA) and 3D printed PEEK implants. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| VISTA technique and 3D printed PMMA implantAlso: minimally invasive vestibular incision subperiosteal tunnel access and 3D printed polymethylmethacrylate implantIntraoral scanning and radiographic examination (CBCT) will be performed to assess the anatomy of the sub nasal area and plan the position, size and thickness of PMMA implant The data will be transferred to 3D planning software to create digital model that fit in the defect followed by 3D printing of the implant using VISTA technique | Procedure or surgery | • Group I (3D printed PMMA implant spacer): |
| VISTA technique and 3D printed PEEK implantAlso: minimally invasive vestibular incision subperiosteal tunnel access and 3D printed Polyether ether ketone implantIntraoral scanning and radiographic examination (CBCT) will be performed to assess the anatomy of the subnasal area and plan the position, size and thickness of PEEK implant The data will be transferred to 3D planning software to create digital model that fit in the defect followed by 3D printing of the implant using VISTA technique | Procedure or surgery | • Group II (3D printed PEEk implant spacer): |
Primary outcome
To measure amount of gingival display in different follow-up intervals
Time frame: at 1, 3, 6 and 12 months postoperatively
To measure amount of gingival display in millimeters in different follow-up intervals.
2 secondary outcomes
To evaluate patient satisfaction
Time frame: at 1, 3, 6 and 12 months postoperatively
to evaluate postoperative pain
Time frame: at 1, 3, 6 and 12 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
- Modifying gummy smile: a minimally invasive approachLink provided by the sponsor.
- A Standardized Technique for Gummy Smile Treatment Using Repeated Botulinum Toxins: A 1-year Follow-up StudyLink provided by the sponsor.
- A comparison between modified and conventional surgical techniques for surgical lip repositioning in the management of the gummy smileLink provided by the sponsor.
- Correction of Gummy Smile by Surgical Lip Repositioning with Myotomy versus Botox Injection TechniqueLink provided by the sponsor.
Related trials for Management of Gummy Smile
Not yet recruiting
Effect of Cross-linked Hyaluronic Acid Filler Versus Botulinum Toxin Type A (Botox) in Management of Gummy Smile
Gummy Smile Due to Hypermobile Upper Lip
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.
Hala A. Abuel Ela, Professor study director
Professor of Oral Medicine, Periodontology, Oral Diagnosis, Faculty of Dentistry, Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing VISTA technique and 3D printed PMMA implant and VISTA technique and 3D printed PEEK implant in people with Management of Gummy Smile, run by Ain Shams 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Jun 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nada S. Ahmed, PHD student (01060041571, nadazidan1271994@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To measure amount of gingival display in different follow-up intervals (time frame: at 1, 3, 6 and 12 months postoperatively). 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 25 Jun 2024.