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Clinical Trials/NCT06580821
NCT06580821RecruitingNot Applicable

Evaluation of the Efficacy of the Modified Free Gingival Graft Technique

Universidad de Especialidades Espiritu Santo2 sites in 1 country30 target enrollmentStarted: September 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
30
Locations
2
Primary Endpoint
To evaluate the long-term efficacy of the modified free gingival graft technique on root coverage.

Study Overview

Brief Summary

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Masking Description

The participants will not know which technique is being used to treat gingival recession.

The investigator will not be informed which cover up treatment was performed in the gingival recession.

The outcomes assessor will not be informed of which procedures were performed on the participants.

Eligibility Criteria

Ages
18 Years to 64 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Universidad de Especialidades Espiritu Santo
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Antonio Lanata Flores

Assistant Professor

Universidad de Especialidades Espiritu Santo

Study Sites (2)

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