Evaluation of Different Periodontal Plastic Surgery Techniques for Gummy Smile Treatment

Investigating different periodontal surgery techniques to treat gummy smile.

Study Overview

• Status: Recruiting
• Conditions: Gummy Smile
• Intervention / Treatment: Device: Peek device; Other: Crown lengthening/gingivectomy

Detailed 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;

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Filipa Sousa; Phone Number: +351 915029812; Email: filipampsousa@gmail.com
• Study Contact Backup: Name: Inês Gomes; Phone Number: 212946748; Email: inesgomes.ciiem@egasmoniz.edu.pt

Study Locations

• Portugal
  • Almada, Portugal, 2800-288
    • Recruiting
    • Egas Moniz Cooperativa de Ensino Superior
    • Contact: Inês Gomes; Phone Number: 212946748; Email: inesgomes.ciiem@egasmoniz.edu.pt
    • Contact: Filipa Sousa; Phone Number: +351915028912; Email: filipampsousa@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects with gummy smile and with upper lip hypermobility; Periodontal plastic surgery for peek device implantation with 4 screws in the anterior maxillary area	Device: Peek device; Participants with gummy smile will be recruited from the Dental Clinic of Instituto Universitário Egas Moniz
Experimental: 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	Device: Peek device; Participants with gummy smile will be recruited from the Dental Clinic of Instituto Universitário Egas Moniz
Experimental: Patiens who refuse device implantation - control group; Gingivectomy/crown lengthening procedure	Other: Crown lengthening/gingivectomy; Participante with gummy smile will be recruited from the Dental Clinic of Instituto Universitário Egas Moniz

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Superior incisors proportion (height x length)	Superior incisors height and lenght	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
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

Collaborators and Investigators

• Sponsor: Egas Moniz - Cooperativa de Ensino Superior, CRL
• Collaborators: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start (Anticipated): February 15, 2023
• Primary Completion (Anticipated): September 15, 2023
• Study Completion (Anticipated): December 15, 2023

Study Registration Dates

• First Submitted: September 22, 2022
• First Submitted That Met QC Criteria: November 7, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Estimate): January 6, 2023
• Last Update Submitted That Met QC Criteria: January 4, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PHDFPS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No