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NCT Number: NCT06580821

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.

Recruiting

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidadees

Samborondón, Guayas, 09-01-952, Ecuador

Location status: Recruiting

Location contact

Antonio G Lanata, 5 level

CONTACT

[email protected]

+593983820084

Sandy Cristina Gonzalez, 3 level

CONTACT

+593997472385

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mucogingigval surgery

Procedure

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Universidad de Especialidades Espiritu Santo

Other

Registry information

Official study title

Evaluation of the Efficacy of the Modified Free Gingival Graft Technique

Acronym: FGG

Important dates

Study start
2024
Primary completion
2024
Study completion
2029
First posted
Aug 30, 2024
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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