Evaluation of Different Periodontal Plastic Surgery Techniques for Gummy Smile Treatment

Gummy Smile Clinical Trial

Official title:

Evaluation of Different Periodontal Plastic Surgery Techniques for Gummy Smile Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05616715
• Other study ID #: PHDFPS
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: December 15, 2023

Study information

• Verified date: September 2022
• Source: Egas Moniz - Cooperativa de Ensino Superior, CRL
• Contact: Filipa Sousa
• Phone: +351 915029812
• Email: filipampsousa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigating different periodontal surgery techniques to treat gummy smile.

Description:

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;

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 15, 2023
• Est. primary completion date: September 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gummy Smile

Intervention

Device:
• Peek device
Participants with gummy smile will be recruited from the Dental Clinic of Instituto Universitário Egas Moniz

Other:
• Crown lengthening/gingivectomy
Participante with gummy smile will be recruited from the Dental Clinic of Instituto Universitário Egas Moniz

Locations

Country	Name	City	State
Portugal	Egas Moniz Cooperativa de Ensino Superior	Almada

Sponsors (2)

Lead Sponsor	Collaborator
Egas Moniz - Cooperativa de Ensino Superior, CRL	Zimmer Biomet

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Superior incisors proportion (height x length)	Superior incisors height and lenght	Baseline and week 24
Primary	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
Primary	Change in Periodontal probing	Three probes (mesial, buccal and distal) for exposed teeth during smile	Baseline and week 24
Primary	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
Primary	Change in Interlabial space at rest	When in rest position, measure distance between lips	Baseline and week 24