Efficacy of the Modified Free Gingival Graft Technique (FGG)

October 25, 2024 updated by: Antonio Lanata Flores, Universidad de Especialidades Espiritu Santo

Evaluation of the Efficacy of the Modified Free Gingival Graft Technique

Gingival recessions can be defined as the exposure of the root surface after an apical migration of the gingival margin in relation to the cemento-enamel junction. Gingival recessions affect both younger and older populations. Various surveys revealed that 88% of people ≥65 years of age and 50% of people between 18 and 64 years of age have ≥1 site with gingival recession. Gingival recessions can occur due to anatomical, pathological factors or trauma and will result in a loss of attachment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ecuador
    • Guayas
      • Samborondón, Guayas, Ecuador, 09-01-952
        • Recruiting
        • Universidadees
        • Contact:
        • Contact:
          • Sandy Cristina Gonzalez, 3 level
          • Phone Number: +593997472385

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients with at least two or less localized recession in mandibular incisors
  • Cairo type 1 recession
  • Patients who have good plaque control of less than 20%
  • Patients between 18-64 years old

Exclusion Criteria:

  • Systemically compromised patients
  • Smoker patients
  • Pregnant women, breastfeeding or use of oral contraceptives
  • Patients who are taking medication that may affect healing and coagulation
  • Previous periodontal surgeries in the RG area
  • Patients with periodontal disease
  • Patients who have undergone chemotherapy and radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modified free gingival graft
Procedure: mucogingigval surgery
Is a form of mucogingival surgery that attempts to improve the height of the keratinized tissue (KT), as well as augment the thickness of the gingival phenotype to facilitate meticulous oral hygiene.
Active Comparator: Conventional free gingival graft
Procedure: mucogingigval surgery
Is a form of mucogingival surgery that attempts to improve the height of the keratinized tissue (KT), as well as augment the thickness of the gingival phenotype to facilitate meticulous oral hygiene.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the long-term efficacy of the modified free gingival graft technique on root coverage.
Time Frame: From enrollment to the end of treatment at 12 months, evaluating at 7 days, 14 days, at the first month and after that every 3 months.
This technique is a modified version of the Free gingival graft, which is a surgery that attempts to improve the height of the keratinized tissue, as well as augment the thickness of the gingival phenotype. This modified version is based on a connective pedicle flap is flipped from its apical origin to cover the exposed root surface prior to the positioning of the Free gingival Graft. The rationale behind the approach is to improve the revascularization of the graft.
From enrollment to the end of treatment at 12 months, evaluating at 7 days, 14 days, at the first month and after that every 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Especialidades Espiritu Santo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Estimated)

December 15, 2024

Study Completion (Estimated)

December 15, 2029

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

August 29, 2024

First Posted (Actual)

August 30, 2024

Study Record Updates

Last Update Posted (Actual)

October 29, 2024

Last Update Submitted That Met QC Criteria

October 25, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024-ODONT-002A

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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