Efficacy of the Modified Free Gingival Graft Technique

NCT ID: NCT06580821

Last Updated: 2024-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-01

Study Completion Date

2029-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Modified Free Gingival Graft , Connective Tissue Graft

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized clinical trial will performed in 30 patient with RT1 gingival recessions at mandibular incisors
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
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.

Study Groups

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Modified free gingival graft

Group Type EXPERIMENTAL

mucogingigval surgery

Intervention Type 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

Group Type ACTIVE_COMPARATOR

mucogingigval surgery

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universidad de Especialidades Espiritu Santo

OTHER

Sponsor Role lead

Responsible Party

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Antonio Lanata Flores

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidadees

Samborondón, Guayas, Ecuador

Site Status RECRUITING

Countries

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Ecuador

Facility Contacts

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Antonio G Lanata, 5 level

Role: primary

+593983820084

Sandy Cristina Gonzalez, 3 level

Role: backup

+593997472385

References

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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.

Reference Type BACKGROUND
PMID: 36627509 (View on PubMed)

Other Identifiers

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2024-ODONT-002A

Identifier Type: -

Identifier Source: org_study_id

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