NCT05616715

Brief Summary

Investigating different periodontal surgery techniques to treat gummy smile.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 15, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

February 15, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2023

Completed
Last Updated

January 6, 2023

Status Verified

September 1, 2022

Enrollment Period

7 months

First QC Date

September 22, 2022

Last Update Submit

January 4, 2023

Conditions

Gummy Smile

Outcome Measures

Primary Outcomes (5)

  • Change in Superior incisors proportion (height x length)

    Superior incisors height and lenght

    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)

    Baseline and week 24

  • Change in Periodontal probing

    Three probes (mesial, buccal and distal) for exposed teeth during smile

    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

    Baseline and week 24

  • Change in Interlabial space at rest

    When in rest position, measure distance between lips

    Baseline and week 24

Study Arms (3)

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

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

Device: Peek device

Patiens who refuse device implantation - control group

EXPERIMENTAL

Gingivectomy/crown lengthening procedure

Other: Crown lengthening/gingivectomy

Interventions

Peek deviceDEVICE

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 hypermobilitySubjects with gummy smile and with upper lip hypermobility
Crown lengthening/gingivectomyOTHER

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

Patiens who refuse device implantation - control group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Egas Moniz Cooperativa de Ensino Superior

Almada, 2800-288, Portugal

RECRUITING

MeSH Terms

Interventions

Crown LengtheningGingivectomy

Intervention Hierarchy (Ancestors)

Orthodontics, CorrectiveOrthodonticsDentistryOral Surgical ProceduresSurgical Procedures, OperativePeriodontics

Central Study Contacts

Filipa Sousa

CONTACT

+351 915029812filipampsousa@gmail.com

Ines Gomes

CONTACT

212946748inesgomes.ciiem@egasmoniz.edu.pt

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2022

First Posted

November 15, 2022

Study Start

February 15, 2023

Primary Completion

September 15, 2023

Study Completion

December 15, 2023

Last Updated

January 6, 2023

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

PT(1)