Gummy SmileNCT05616715
Evaluation of Different Periodontal Plastic Surgery Techniques for Gummy Smile Treatment
A study testing Peek device and Crown lengthening/gingivectomy in people with Gummy Smile, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
Trial summary
Investigating different periodontal surgery techniques to treat gummy smile. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Gummy Smile
- What is being tested?
- Peek device and Crown lengthening/gingivectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePortugal
- Study dates
- 15 Feb 2023to 15 Dec 2023
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Gummy smile due to two etiologies (combined or isolated);
- Short clinical crown of teeth due to the altered passive eruption;
- Upper lip hyperactivity
Who cannot join
- Smokers;
- Pregnant or breastfeeding patients;
- Patients with systemic diseases that can affect the result of surgical treatment (such as diabetes, heart diseases and taking blood anticoagulant medication, blood diseases, immunodeficiency disease etc.);
- Cleft lip;
- Craniofacial syndrome;
- Facial alteration surgeries during the study;
- Active orto treatment.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Egas Moniz Cooperativa de Ensino Superior
Almada, 2800-288
Filipa Sousa, +351915028912, filipampsousa@gmail.com
Inês Gomes, 212946748, inesgomes.ciiem@egasmoniz.edu.pt
About this study
Investigating different periodontal surgery techniques to treat gummy smile.
Read the detailed description
Participants will be subdivided into 3 (three) groups:
- Patients with upper lip hypermobility - surgery for device implantation in the anterior area of the maxilla;
- Patients with short teeth and upper lip hypermobility - flap surgery/gingivectomy and device implantation; and
- Patients who refuse implantation - flap surgery/gingivectomy;
- Conditions
- Gummy Smile
- Being tested
- Peek device, Crown lengthening/gingivectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peek deviceDevice
Participants with gummy smile will be recruited from the Dental Clinic of Instituto Universitário Egas Moniz
Crown lengthening/gingivectomyOther
Participante with gummy smile will be recruited from the Dental Clinic of Instituto Universitário Egas Moniz
| Study group | Role | What they receive |
|---|---|---|
| Subjects with gummy smile and with upper lip hypermobility | Experimental | Periodontal plastic surgery for peek device implantation with 4 screws in the anterior maxillary area Receives: Device: Peek device |
| Subjects with gummy smile and with short teeth and upper lip hypermobility | Experimental | Gingivectomy/crown lengthening and device implantation in the anterior maxillary area. First crown lengthening procedure (CLP) will be performed creating a distance of 3mm between cementoenamel junction (CEJ). Next peek device will be position with 4 screws Receives: Device: Peek device |
| Patiens who refuse device implantation - control group | Experimental | Gingivectomy/crown lengthening procedure Receives: Other: Crown lengthening/gingivectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Superior incisors proportion (height x length)
Superior incisors height and lenght
Measured: Baseline and week 24
Change in Exposure of central incisors at rest
Measurement between incisal border of central incisors and the border of the lower lip during smile (in millimeters)
Measured: Baseline and week 24
Change in Periodontal probing
Three probes (mesial, buccal and distal) for exposed teeth during smile
Measured: Baseline and week 24
Change in Gengiva exposure at rest and forced smile
When lips are in rest position measure the amount of exposed gingiva and during a forced smile, make the same measure
Measured: Baseline and week 24
Change in Interlabial space at rest
When in rest position, measure distance between lips
Measured: Baseline and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study start15 Feb 2023 (estimated)
- Primary completion15 Sep 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRL
- Sponsor type
- University, hospital or other
- Collaborators
- Zimmer Biomet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616715
- Sponsor's protocol ID
- PHDFPS
- Status last verified
- Sep 2022
- First submitted
- 22 Sep 2022
- Last updated
- 6 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Different Periodontal Plastic Surgery Techniques for Gummy Smile Treatment
- ClinicalTrials.gov ID
- NCT05616715
- Acronym / sponsor ID
- PHDFPS
- Conditions
- Gummy Smile
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Egas Moniz - Cooperativa de Ensino Superior, CRLUniversity, hospital or other
- Collaborators
- Zimmer Biomet
- Study start
- 15 Feb 2023 (estimated)
- Primary completion
- 15 Sep 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 15 Nov 2022 (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.
Investigating different periodontal surgery techniques to treat gummy smile.
Detailed description
Participants will be subdivided into 3 (three) groups:
- Patients with upper lip hypermobility - surgery for device implantation in the anterior area of the maxilla;
- Patients with short teeth and upper lip hypermobility - flap surgery/gingivectomy and device implantation; and
- Patients who refuse implantation - flap surgery/gingivectomy;
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Subjects with gummy smile and with upper lip hypermobility | Experimental | Device: Peek devicePeriodontal plastic surgery for peek device implantation with 4 screws in the anterior maxillary area |
| Subjects with gummy smile and with short teeth and upper lip hypermobility | Experimental | Device: Peek deviceGingivectomy/crown lengthening and device implantation in the anterior maxillary area. First crown lengthening procedure (CLP) will be performed creating a distance of 3mm between cementoenamel junction (CEJ). Next peek device will be position with 4 screws |
| Patiens who refuse device implantation - control group | Experimental | Other: Crown lengthening/gingivectomyGingivectomy/crown lengthening procedure |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Gummy smile due to two etiologies (combined or isolated);
- Short clinical crown of teeth due to the altered passive eruption;
- Upper lip hyperactivity
Key exclusion criteria (7 listed)
- Smokers;
- Pregnant or breastfeeding patients;
- Patients with systemic diseases that can affect the result of surgical treatment (such as diabetes, heart diseases and taking blood anticoagulant medication, blood diseases, immunodeficiency disease etc.);
- Cleft lip;
- Craniofacial syndrome;
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 |
|---|---|---|
| Peek deviceParticipants with gummy smile will be recruited from the Dental Clinic of Instituto Universitário Egas Moniz | Device | Subjects with gummy smile and with short teeth and upper lip hypermobility, Subjects with gummy smile and with upper lip hypermobility |
| Crown lengthening/gingivectomyParticipante with gummy smile will be recruited from the Dental Clinic of Instituto Universitário Egas Moniz | Other | Patiens who refuse device implantation - control group |
Primary outcome
Change in Superior incisors proportion (height x length)
Time frame: Baseline and week 24
Superior incisors height and lenght
Change in Exposure of central incisors at rest
Time frame: Baseline and week 24
Measurement between incisal border of central incisors and the border of the lower lip during smile (in millimeters)
Change in Periodontal probing
Time frame: Baseline and week 24
Three probes (mesial, buccal and distal) for exposed teeth during smile
Change in Gengiva exposure at rest and forced smile
Time frame: Baseline and week 24
When lips are in rest position measure the amount of exposed gingiva and during a forced smile, make the same measure
Change in Interlabial space at rest
Time frame: Baseline and week 24
When in rest position, measure distance between lips
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2023.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peek device and Crown lengthening/gingivectomy in people with Gummy Smile, run by Egas Moniz - Cooperativa de Ensino Superior, CRL at 1 site in Portugal.
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 7 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 6 Jan 2023. 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 Portugal. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Filipa Sousa (+351 915029812, filipampsousa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Superior incisors proportion (height x length) (time frame: Baseline and week 24). The study lists 5 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 6 Jan 2023.