ClinicalTrials.gg
RecruitingNCT06580821FGGUpdated Oct 29, 2024

Efficacy of the Modified Free Gingival Graft Technique

An interventional study of mucogingigval surgery in Modified Free Gingival Graft , Connective Tissue Graft, sponsored by Universidad de Especialidades Espiritu Santo. Recruiting at 1 site in Ecuador. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-29.

Sponsored by Universidad de Especialidades Espiritu Santo · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Sep 2024; still recruiting 2 years 2 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Modified Free Gingival Graft , Connective Tissue Graft

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Keywords

  • Gingival Recession
  • Surgical Flaps
  • Connective Tissue
03

In context

Gingival Recession

426 studies on the registry are indexed under Gingival Recession; 106 are open to participants now.

This study's planned enrollment of 30 is close to the median of 30 across 390 interventional studies indexed under Gingival Recession.

Browse Gingival Recession studies →

Lead sponsor

Universidad de Especialidades Espiritu Santo is the lead sponsor of 10 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Systemically compromised patients
  • Smoker patients
  • Pregnant women, breastfeeding or use of oral
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Modified free gingival graft

    Procedure: mucogingigval surgery

  • Active comparator
    Conventional free gingival graft

    Procedure: mucogingigval surgery

Interventions

  • Proceduremucogingigval 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.

06

What researchers measure

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.

    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.

07

Study locations

1 of 1 sites recruiting
08

References and documents

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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2024 (actual). Primary completion is estimated for Dec 2024, 3 months after the start.

Of 233 non-industry interventional studies with no phase under Gingival Recession, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's planned 3 months is below that.

Counting every sponsor, half of 235 studies reached it within 19 months; a quarter within 11 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 27, 2024
First posted
Aug 30, 2024
StartActual
Sep 1, 2024
Primary completionEst.
Dec 15, 2024
CompletionEst.
Dec 15, 2029
Last update
Oct 29, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06580821
Lead sponsor
Universidad de Especialidades Espiritu Santo
Responsible party
Antonio Lanata Flores (Assistant Professor, Universidad de Especialidades Espiritu Santo) — Principal investigator
First posted
Aug 30, 2024
Start date
Sep 1, 2024
Primary completion
Dec 15, 2024 (estimated)
Completion
Dec 15, 2029 (estimated)
Last update
Oct 29, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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