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Gingiva AtrophyNCT06037694

Effectiveness of Meshed Free Gingival Graft for Widening of Keratinized Tissues

A study testing Conventional Free Gingival Graft and 'Mesh Free Gingival Graft in people with Gingiva Atrophy, run by Göteborg University at 1 site in United Arab Emirates.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The overall objective of this project is to evaluate, over a period of 1 year, the outcomes of either conventional free gingival graft (FGG) or mesh-FGG to increase the width of keratinized mucosa (KM) at implant sites. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Gingiva Atrophy
What is being tested?
Conventional Free Gingival Graft and 'Mesh Free Gingival Graft
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited Arab Emirates
Study dates
1 Jan 2024to 1 Aug 2026
Phase
Interventional
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥18 years of age,
  • systemically healthy,
  • presence of ≥2 adjacent implants in both sides of the mandibles showing <2 mm of KM on the buccal aspects,
  • subjects have to present with discomfort from brushing and/or difficulties in maintaining proper home care due to inadequate dimension of KM
  • Full-Mouth Plaque Score (FMPS) <20%,
  • Full-Mouth Bleeding Score (FMBS) <20%.

Who cannot join

  • pregnancy or lactation,
  • tobacco smoking,
  • uncontrolled medical condition,
  • medication that can affect gingival conditions.

Trial locations and contacts

1 site in 1 country.

Olivier Carcuac, DDS, PhD contact

556275575 ext. 00971

olivier.carcuac@gu.se

Jan Derks, DDS, PhD contact

317863124 ext. 0046

jan.derks@odontologi.gu.se

United Arab Emirates1 site, 1 recruiting

  • ConfiDent ® Dental Surgery Clinic, Dubai Palm Jumeirah

    Dubai, Dubai, 0000

    Olivier Carcuac, DDS, PhD, 0097556275575, olivier.carcuac@gu.se

    Recruiting

Other trials in United Arab Emirates

About this study

Official title: Widening of Keratinized Tissues With an Expanded Meshed Free Gingival Graft: a Multi-center Randomized Controlled Trial.

The overall objective of this project is to evaluate, over a period of 1 year, the outcomes of either conventional free gingival graft (FGG) or mesh-FGG to increase the width of keratinized mucosa (KM) at implant sites.

Read the detailed description

The importance of the width of keratinized mucosa (KM) at implant sites remains a subject of ongoing debate. Reduced dimensions of KM (width <2 mm) are associated with mucosal recession, biofilm accumulation, soft-tissue inflammation, marginal bone loss, peri-implantitis and patient discomfort. Surgical options to increase the width of KM include an apically positioned flap, either alone or in combination with an autogenous graft or a xenogeneic collagen matrix. The free gingival graft (FGG) is a well-established technique with a history of successful clinical use. The harvesting procedure for autogenous graft from the palatal mucosa, however, is usually associated with significant patient morbidity, especially when there is a need to graft extensive mucosal areas. To overcome this problem, various graft modifications have been proposed to limit the need for large-area autografts. Examples include the accordion technique, the strip gingival autograft technique, and a vertical modification of the strip gingival graft. The expanded mesh graft, another graft modification, has been used in the field of plastic surgery, especially in the treatment of large burn wounds. Recently, De Greef, Carcuac, De Mars et al. proposed this technique to be used in periodontal plastic surgery, more specifically, in the widening of KM at implant sites by means of a meshed free gingival graft (mesh-FGG). In this case series, initially inadequate width of KM in edentulous areas could be successfully increased prior to implant installation, without the need for any extensive autograft harvesting. Data from trials comparing mesh-FGG to conventional FGG and assessing the long-term efficacy of this novel technique, however, are missing.

The investigators hypothesize that the mesh-FGG technique will demonstrate similar clinical results (non-inferiority: increase in KM width) but improved patient-reported outcomes (superiority: post-surgical morbidity) compared to the FGG.

Conditions
Gingiva Atrophy
Being tested
Conventional Free Gingival Graft, 'Mesh Free Gingival Graft
Medical subject headings
Gingival Recession

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Conventional Free Gingival GraftProcedure or surgery

    Implant site with insufficient dimensions of KM will be covered by a conventional free gingival graft.

  • 'Mesh Free Gingival GraftProcedure or surgery

    Implant site with insufficient dimensions of KM will be covered by a expanded meshed free gingival graft.

Study groups in NCT06037694
Study groupRoleWhat they receive
Free Gingival GraftActive comparatorA mucogingival surgery where a conventional free gingival graft harvested from the palate is placed on a recipient site prepared to increase the width of KM at implant sites.
Receives: Procedure: Conventional Free Gingival Graft
Meshed Free Gingival GraftExperimentalA mucogingival surgery where a meshed free gingival graft harvested from the palate is placed on a recipient site prepared to increase the width of KM at implant sites.
Receives: Procedure: 'Mesh Free Gingival Graft

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of Keratinized Mucosa width (KMW)

    Measured as the distance from the muco-gingival-junction to the occlusal portion of the mucosa

    Measured: up to 1 year

Secondary outcomes (3)

  1. Changes of Keratinized Mucosa Thickness (KMT)

    measured by a therapeutic probe with a rubber stop

    Measured: up to 1 year

  2. Patient Morbidity

    Measured with Visual Analogue Scale (VAS), which consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')

    Measured: up to 2 weeks

  3. Patient Satisfaction

    Measured with Visual Analogue Scale (VAS), which consists of a 10cm line, with two end points representing 0 ('not satisfied') and 10 ('satisfied as much as it could possibly be')

    Measured: up to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2023
  2. Study start1 Jan 2024
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Aug 2026 (estimated)

Resources

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
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06037694
Sponsor's protocol ID
OCarcuac-meshFGG
Status last verified
Oct 2024
First submitted
7 Sep 2023
Last updated
21 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Schwarz F, Derks J, Monje A, Wang HL. Peri-implantitis. J Clin Periodontol. 2018 Jun;45 Suppl 20:S246-S266. doi: 10.1111/jcpe.12954.

    PubMed 29926484

  • Sanz M, Schwarz F, Herrera D, McClain P, Figuero E, Molina A, Monje A, Montero E, Pascual A, Ramanauskaite A, Renouard F, Sader R, Schiegnitz E, Urban I, Heitz-Mayfield L. Importance of keratinized mucosa around dental implants: Consensus report of group 1 of the DGI/SEPA/Osteology Workshop. Clin Oral Implants Res. 2022 Jun;33 Suppl 23:47-55. doi: 10.1111/clr.13956.

    PubMed 35763021

  • Lim HC, An SC, Lee DW. A retrospective comparison of three modalities for vestibuloplasty in the posterior mandible: apically positioned flap only vs. free gingival graft vs. collagen matrix. Clin Oral Investig. 2018 Jun;22(5):2121-2128. doi: 10.1007/s00784-017-2320-y. Epub 2017 Dec 23.

    PubMed 29275490

  • Tavelli L, Barootchi S, Avila-Ortiz G, Urban IA, Giannobile WV, Wang HL. Peri-implant soft tissue phenotype modification and its impact on peri-implant health: A systematic review and network meta-analysis. J Periodontol. 2021 Jan;92(1):21-44. doi: 10.1002/JPER.19-0716. Epub 2020 Aug 9.

    PubMed 32710810

  • Singh M, Nuutila K, Collins KC, Huang A. Evolution of skin grafting for treatment of burns: Reverdin pinch grafting to Tanner mesh grafting and beyond. Burns. 2017 Sep;43(6):1149-1154. doi: 10.1016/j.burns.2017.01.015. Epub 2017 Jan 30.

    PubMed 28153583

  • De Greef A, Carcuac O, De Mars G, Stankov V, Cortasse B, Giordani G, Van Dooren E. The expanded mesh free gingival graft: A novel approach to increase the width of keratinized mucosa. Clin Adv Periodontics. 2024 Sep;14(3):157-164. doi: 10.1002/cap.10264. Epub 2023 Aug 16.

    PubMed 37551510

  • Thoma DS, Naenni N, Figuero E, Hammerle CHF, Schwarz F, Jung RE, Sanz-Sanchez I. Effects of soft tissue augmentation procedures on peri-implant health or disease: A systematic review and meta-analysis. Clin Oral Implants Res. 2018 Mar;29 Suppl 15:32-49. doi: 10.1111/clr.13114.

    PubMed 29498129

Questions about this trial

What is this clinical trial studying?

A study testing Conventional Free Gingival Graft and 'Mesh Free Gingival Graft in people with Gingiva Atrophy, run by Göteborg University at 1 site in United Arab Emirates.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Olivier Carcuac, DDS, PhD (556275575 ext. 00971, olivier.carcuac@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of Keratinized Mucosa width (KMW) (time frame: up to 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06037694, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2025.

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