Evaluation of Different Periodontal Plastic Surgery Techniques for Gummy Smile Treatment

NCT ID: NCT05616715

Last Updated: 2023-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2023-12-15

Brief Summary

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Investigating different periodontal surgery techniques to treat gummy smile.

Detailed Description

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Participants will be subdivided into 3 (three) groups:

1. Patients with upper lip hypermobility - surgery for device implantation in the anterior area of the maxilla;
2. Patients with short teeth and upper lip hypermobility - flap surgery/gingivectomy and device implantation; and
3. Patients who refuse implantation - flap surgery/gingivectomy;

Conditions

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Gummy Smile

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Subjects with gummy smile and with upper lip hypermobility

Periodontal plastic surgery for peek device implantation with 4 screws in the anterior maxillary area

Group Type EXPERIMENTAL

Peek device

Intervention Type DEVICE

Participants with gummy smile will be recruited from the Dental Clinic of Instituto Universitário Egas Moniz

Subjects with gummy smile and with short teeth and upper lip hypermobility

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

Group Type EXPERIMENTAL

Peek device

Intervention Type DEVICE

Participants with gummy smile will be recruited from the Dental Clinic of Instituto Universitário Egas Moniz

Patiens who refuse device implantation - control group

Gingivectomy/crown lengthening procedure

Group Type EXPERIMENTAL

Crown lengthening/gingivectomy

Intervention Type OTHER

Participante with gummy smile will be recruited from the Dental Clinic of Instituto Universitário Egas Moniz

Interventions

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Peek device

Participants with gummy smile will be recruited from the Dental Clinic of Instituto Universitário Egas Moniz

Intervention Type DEVICE

Crown lengthening/gingivectomy

Participante with gummy smile will be recruited from the Dental Clinic of Instituto Universitário Egas Moniz

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Gummy smile due to two etiologies (combined or isolated);
* Short clinical crown of teeth due to the altered passive eruption;
* Upper lip hyperactivity

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zimmer Biomet

INDUSTRY

Sponsor Role collaborator

Egas Moniz - Cooperativa de Ensino Superior, CRL

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Egas Moniz Cooperativa de Ensino Superior

Almada, , Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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Filipa Sousa

Role: CONTACT

+351 915029812

Ines Gomes

Role: CONTACT

212946748

Facility Contacts

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Filipa Sousa

Role: primary

+351915028912

Inês Gomes

Role: backup

212946748

Other Identifiers

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PHDFPS

Identifier Type: -

Identifier Source: org_study_id

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