Modified Free Gingival Graft , Connective Tissue GraftFGGNCT06580821
Efficacy of the Modified Free Gingival Graft Technique
A study testing mucogingigval surgery in people with Modified Free Gingival Graft , Connective Tissue Graft, run by Universidad de Especialidades Espiritu Santo at 1 site in Ecuador.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Modified Free Gingival Graft , Connective Tissue Graft
- What is being tested?
- mucogingigval surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEcuador
- Study dates
- 1 Sep 2024to 15 Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ecuador1 site, 1 recruiting
- Recruiting
Universidadees
Samborondón, Guayas, 09-01-952
Antonio G Lanata, 5 level, +593983820084, alanataf@uees.edu.ec
Sandy Cristina Gonzalez, 3 level, +593997472385
About this study
Official title: 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.
- Being tested
- mucogingigval surgery
- Keywords
- Gingival Recession, Surgical Flaps, Connective Tissue
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mucogingigval surgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Modified free gingival graft | Experimental | Not described Receives: Procedure: mucogingigval surgery |
| Conventional free gingival graft | Active comparator | Not described Receives: Procedure: mucogingigval surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start1 Sep 2024
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Modified Free Gingival Graft , Connective Tissue GraftStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial will performed in 30 patient with RT1 gingival recessions at mandibular incisors
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Especialidades Espiritu Santo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antonio Lanata Flores, Universidad de Especialidades Espiritu Santo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580821
- Sponsor's protocol ID
- 2024-ODONT-002A
- Acronym
- FGG
- Status last verified
- Oct 2024
- First submitted
- 27 Aug 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36627509