Efficacy of the Modified Free Gingival Graft Technique

NCT06580821 | Recruiting

• 1 other identifier: 2024-ODONT-002A
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Modified Free Gingival Graft , Connective Tissue Graft

Keywords

Gingival Recession; Surgical Flaps; Connective Tissue

Outcome Measures

Primary Outcomes (1)

• To evaluate the long-term efficacy of the modified free gingival graft technique on root coverage.

  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.

Study Arms (2)

Modified free gingival graft

EXPERIMENTAL

Procedure: mucogingigval surgery

Conventional free gingival graft

ACTIVE COMPARATOR

Procedure: mucogingigval surgery

Interventions

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.

Conventional free gingival graft; Modified free gingival graft

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Especialidades Espiritu Santo: lead

Study Sites (1)

Universidadees

Samborondón, Guayas, 09-01-952, Ecuador

RECRUITING

Related Publications (1)

• Carcuac O, Trullenque-Eriksson A, Derks J. Modified free gingival graft technique for treatment of gingival recession defects at mandibular incisors: A randomized clinical trial. J Periodontol. 2023 Jun;94(6):722-730. doi: 10.1002/JPER.22-0581. Epub 2023 Jan 30.

  PMID: 36627509 BACKGROUND

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized clinical trial will performed in 30 patient with RT1 gingival recessions at mandibular incisors

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 30, 2024
• Study Start: September 1, 2024
• Primary Completion: December 15, 2024
• Study Completion (Estimated): December 15, 2029
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EC (1)